Fresh Recalls

FDA recalls — page 9

2,784 recent recalls from the U.S. Food & Drug Administration in our current data (last 90 days). Showing 2,401–2,700, newest first.

FDA Class II · Medical device · May 13, 2026

DEX Ophthalmic Tissue Forceps recall — Katalyst Surgical, LLC

Field Safety Corrective Action for IFU in DEX Forceps and Scissors.

Company / brand: Katalyst Surgical recalls

Official ID Z-2075-2026 · Official record ↗

FDA Class II · Medical device · May 13, 2026

DEX Ophthalmic Tissue Forceps recall — Katalyst Surgical, LLC

Field Safety Corrective Action for IFU in DEX Forceps and Scissors.

Company / brand: Katalyst Surgical recalls

Official ID Z-2074-2026 · Official record ↗

FDA Class II · Medical device · May 13, 2026

DEX Ophthalmic Tissue Forceps recall — Katalyst Surgical, LLC

Field Safety Corrective Action for IFU in DEX Forceps and Scissors.

Company / brand: Katalyst Surgical recalls

Official ID Z-2073-2026 · Official record ↗

FDA Class II · Medical device · May 13, 2026

DEX Ophthalmic Tissue Forceps recall — Katalyst Surgical, LLC

Field Safety Corrective Action for IFU in DEX Forceps and Scissors.

Company / brand: Katalyst Surgical recalls

Official ID Z-2072-2026 · Official record ↗

FDA Class II · Medical device · May 13, 2026

DEX Ophthalmic Tissue Forceps recall — Katalyst Surgical, LLC

Field Safety Corrective Action for IFU in DEX Forceps and Scissors.

Company / brand: Katalyst Surgical recalls

Official ID Z-2071-2026 · Official record ↗

FDA Class II · Medical device · May 13, 2026

DEX Ophthalmic Tissue Forceps recall — Katalyst Surgical, LLC

Field Safety Corrective Action for IFU in DEX Forceps and Scissors.

Company / brand: Katalyst Surgical recalls

Official ID Z-2070-2026 · Official record ↗

FDA Class II · Medical device · May 13, 2026

DEX Ophthalmic Tissue Forceps recall — Katalyst Surgical, LLC

Field Safety Corrective Action for IFU in DEX Forceps and Scissors.

Company / brand: Katalyst Surgical recalls

Official ID Z-2069-2026 · Official record ↗

FDA Class II · Medical device · May 13, 2026

Mint Lesion recall — Mint Medical GmbH

If the connection between a mint Lesion workstation and the mint Lesion server is interrupted while performing a read, in rare cases some information may be lost or incorrectly lin…

Company / brand: Mint Medical recalls

Official ID Z-2068-2026 · Official record ↗

FDA Class II · Medical device · May 13, 2026

BioFire Joint Infection (JI) Panel REF recall — BioFire Diagnostics, LLC

Contamination to in-vitro diagnostic test may result in false positives.

Company / brand: BioFire Diagnostics recalls

Official ID Z-2067-2026 · Official record ↗

FDA Class II · Medical device · May 13, 2026

LIFEPAK 15 recall — Physio-Control, Inc.

Some defibrillators serviced between July 2023 through November 2025 were serviced without objective evidence that a Performance Inspection Procedure (PIP) was conducted, and the i…

Company / brand: Physio-Control recalls

Official ID Z-2065-2026 · Official record ↗

FDA Class II · Medical device · May 13, 2026

ERBEFLO 2 recall — Erbe Medical, LLC

Devices providing sterile water/CO2/air to endoscopes were manufactured with a distal irrigation segment connector configuration that may be more susceptible to unintended water fl…

Company / brand: Erbe Medical recalls

Official ID Z-2064-2026 · Official record ↗

FDA Class II · Medical device · May 13, 2026

ERBEFLO CleverCap recall — Erbe Medical, LLC

Devices providing sterile water/CO2/air to endoscopes were manufactured with a distal irrigation segment connector configuration that may be more susceptible to unintended water fl…

Company / brand: Erbe Medical recalls

Official ID Z-2063-2026 · Official record ↗

FDA Class II · Medical device · May 13, 2026

ERBEFLO CleverCap CO2 recall — Erbe Medical, LLC

Devices providing sterile water/CO2/air to endoscopes were manufactured with a distal irrigation segment connector configuration that may be more susceptible to unintended water fl…

Company / brand: Erbe Medical recalls

Official ID Z-2062-2026 · Official record ↗

FDA Class II · Medical device · May 13, 2026

Brand Name recall — Spacelabs Healthcare, Inc.

Due to a manufacturing issue (i.e. malfunctioning of electrical Leakage tester).

Company / brand: Spacelabs Healthcare recalls

Official ID Z-2052-2026 · Official record ↗

FDA Class II · Medical device · May 13, 2026

Prodisc C SK U recall — Centinel Spine, Inc.

Product labeling mix up. The prodisc C SK U.S. Implant Extra Large 6mm product was labeled as a 5mm and prodisc C SK U.S. Implant Extra Large 5mm product was labeled as a 6mm.

Company / brand: Centinel Spine recalls

Official ID Z-2051-2026 · Official record ↗

FDA Class II · Medical device · May 13, 2026

Prodisc C SK U recall — Centinel Spine, Inc.

Product labeling mix up. The prodisc C SK U.S. Implant Extra Large 6mm product was labeled as a 5mm and prodisc C SK U.S. Implant Extra Large 5mm product was labeled as a 6mm.

Company / brand: Centinel Spine recalls

Official ID Z-2050-2026 · Official record ↗

FDA Class II · Medical device · May 13, 2026

LUX-Dx II Plus recall — Boston Scientific Corporation

For some patients upgraded from a LUX-Dx M301 device to a new Model M302 or M312, the new ICM device is not collecting PVC Burden data (both M302/M312) or monitoring for Bradyarrhy…

Company / brand: Boston Scientific recalls

Official ID Z-2049-2026 · Official record ↗

FDA Class II · Medical device · May 13, 2026

LUX-DX II recall — Boston Scientific Corporation

For some patients upgraded from a LUX-Dx M301 device to a new Model M302 or M312, the new ICM device is not collecting PVC Burden data (both M302/M312) or monitoring for Bradyarrhy…

Company / brand: Boston Scientific recalls

Official ID Z-2048-2026 · Official record ↗

FDA Class II · Medical device · May 13, 2026

Brand Name recall — Intuitive Surgical, Inc.

Due to manipulator containing screws with in the arm sub-assembly that my be susceptible to breaking.

Company / brand: Intuitive Surgical recalls

Official ID Z-2046-2026 · Official record ↗

FDA Class I · Medical device · May 13, 2026

Medical Action Industries Inc recall — Medical Action Industries, Inc. 306

Convenience kit contains a syringe in which the rotating adapter may unwind during use, resulting in a loose connection and/or full disconnection between the syringe and manifold"

Company / brand: Medical Action Industries recalls

Official ID Z-2007-2026 · Official record ↗

FDA Class I · Medical device · May 13, 2026

Convenience kits containing Medline Namic Angiographic Control Syringes with Rotating Adap recall — American Contract Systems Inc

Impacted kits contain syringes recalled by Medline Industries. Syringe rotating adaptor may unwind during use, which may result in a loose connection or full disconnection between …

Company / brand: American Contract Systems recalls

Official ID Z-1981-2026 · Official record ↗

FDA Class I · Medical device · May 13, 2026

Halyard VA DETROIT CATH LAB PACK kit recall — AVID Medical, Inc.

Potential risk for Medline syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.

Company / brand: AVID Medical recalls

Official ID Z-1979-2026 · Official record ↗

FDA Class I · Medical device · May 13, 2026

Halyard SAMMC ANGIOGRAPHY kit recall — AVID Medical, Inc.

Potential risk for Medline syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.

Company / brand: AVID Medical recalls

Official ID Z-1978-2026 · Official record ↗

FDA Class I · Medical device · May 13, 2026

Halyard PERC TRAY kit recall — AVID Medical, Inc.

Potential risk for Medline syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.

Company / brand: AVID Medical recalls

Official ID Z-1977-2026 · Official record ↗

FDA Class I · Medical device · May 13, 2026

Halyard NEURO IR PERIPHERAL (PS 64405) kit recall — AVID Medical, Inc.

Potential risk for Medline syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.

Company / brand: AVID Medical recalls

Official ID Z-1976-2026 · Official record ↗

FDA Class I · Medical device · May 13, 2026

Halyard HEART CATH recall — AVID Medical, Inc.

Potential risk for Medline syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.

Company / brand: AVID Medical recalls

Official ID Z-1975-2026 · Official record ↗

FDA Class I · Medical device · May 13, 2026

Halyard CATH LAB kit recall — AVID Medical, Inc.

Potential risk for Medline syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.

Company / brand: AVID Medical recalls

Official ID Z-1974-2026 · Official record ↗

FDA Class I · Medical device · May 13, 2026

Halyard CATH LAB kit recall — AVID Medical, Inc.

Potential risk for Medline syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.

Company / brand: AVID Medical recalls

Official ID Z-1973-2026 · Official record ↗

FDA Class I · Medical device · May 13, 2026

Halyard CARDIAC CATH TRAY SHANDS JAX kit recall — AVID Medical, Inc.

Potential risk for Medline syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.

Company / brand: AVID Medical recalls

Official ID Z-1972-2026 · Official record ↗

FDA Class I · Medical device · May 13, 2026

Halyard CARDIAC CATH PACK SAN23CARDQ kit recall — AVID Medical, Inc.

Potential risk for Medline syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.

Company / brand: AVID Medical recalls

Official ID Z-1971-2026 · Official record ↗

FDA Class I · Medical device · May 13, 2026

Halyard CARDIAC CATH PACK kit recall — AVID Medical, Inc.

Potential risk for Medline syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.

Company / brand: AVID Medical recalls

Official ID Z-1970-2026 · Official record ↗

FDA Class I · Medical device · May 13, 2026

VOCSN V+Pro package recall — Ventec Life Systems, Inc.

Respiratory system intended to provide continuous/intermittent ventilator support, may not have been evaluated under all intended high-pressure conditions during production testing…

Company / brand: Ventec Life Systems recalls

Official ID Z-1942-2026 · Official record ↗

FDA Class I · Medical device · May 13, 2026

Beacon Tip Centimeter Sizing Catheter RPN/GPN NR5 recall — Cook Incorporated

Marker bands may be at an increased risk of cracking/breakage. Potential adverse events that may result include increased procedural time, harms associated with device fragmentatio…

Company / brand: Cook Incorporated recalls

Official ID Z-1936-2026 · Official record ↗

FDA Class I · Medical device · May 13, 2026

Aurous Centimeter Sizing Catheter RPN N5 recall — Cook Incorporated

Marker bands may be at an increased risk of cracking/breakage. Potential adverse events that may result include increased procedural time, harms associated with device fragmentatio…

Company / brand: Cook Incorporated recalls

Official ID Z-1935-2026 · Official record ↗

FDA Class I · Medical device · May 13, 2026

Centimeter Sizing Catheter RPN N5 recall — Cook Incorporated

Marker bands may be at an increased risk of cracking/breakage. Potential adverse events that may result include increased procedural time, harms associated with device fragmentatio…

Company / brand: Cook Incorporated recalls

Official ID Z-1934-2026 · Official record ↗

FDA Class I · Medical device · May 13, 2026

Intuitive 8 mm SureForm 30 Gray Reloads Reference Numbers recall — Intuitive Surgical, Inc.

Reloads for curved-tipped stapler may potentially produce an incomplete staple line.

Company / brand: Intuitive Surgical recalls

Official ID Z-1855-2026 · Official record ↗

FDA Class I · Food · May 13, 2026

Bulk WN-976-782-1 Seasoning for Cheese Sauce recall — Givaudan Flavors Corp

Product has the potential to be contaminated with Salmonella.

Company / brand: Givaudan Flavors recalls

Official ID H-0837-2026 · Official record ↗

FDA Class II · Food · May 13, 2026

Publix Bran Flakes recall — Post Consumer Brands, LLC

Foreign Material (plastic)

Company / brand: Post Consumer Brands recalls

Official ID H-0776-2026 · Official record ↗

FDA Class II · Food · May 13, 2026

LUNDBERG FAMILY FAMRS WHITE RICE JASMINE NET WT 32 OZ (2 lb) 907 g Manufactured and Distri recall — Wehah Farms

Potential contamination with foreign materials.

Company / brand: Wehah Farms recalls

Official ID H-0767-2026 · Official record ↗

FDA Class I · Food · May 13, 2026

RAW FARM ORIGINAL RAW CHEDDAR 80 OZ [BULK ITEM] UPC recall — Raw Farm LLC

Multi-state outbreak of E. coli O157:H7.

Company / brand: Raw Farm recalls

Official ID H-0766-2026 · Official record ↗

FDA Class I · Food · May 13, 2026

RAW FARM SHREDDED RAW CHEDDAR 80 OZ [BULK ITEM] UPC recall — Raw Farm LLC

Multi-state outbreak of E. coli O157:H7.

Company / brand: Raw Farm recalls

Official ID H-0765-2026 · Official record ↗

FDA Class I · Food · May 13, 2026

RAW FARM RAW CHEDDAR SIMPLY SHREDDED Original MADE WITH recall — Raw Farm LLC

Multi-state outbreak of E. coli O157:H7.

Company / brand: Raw Farm recalls

Official ID H-0764-2026 · Official record ↗

FDA Class I · Food · May 13, 2026

RAW FARM RAW CHEDDAR Jalapeno NEVER WARMED ABOVE 102F (TRULY RAW) MADE WITH WHOLE RAW MILK recall — Raw Farm LLC

Multi-state outbreak of E. coli O157:H7.

Company / brand: Raw Farm recalls

Official ID H-0763-2026 · Official record ↗

FDA Class I · Food · May 13, 2026

RAW FARM RAW CHEDDAR Original NEVER WARMED ABOVE 102F (TRULY RAW) MADE WITH WHOLE RAW MILK recall — Raw Farm LLC

Multi-state outbreak of E. coli O157:H7.

Company / brand: Raw Farm recalls

Official ID H-0762-2026 · Official record ↗

FDA Class II · Food · May 13, 2026

Good & Gather Fresh from Our Deli recall — Target Corporation

Undeclared allergens (sesame and soy)

Company / brand: Target recalls

Official ID H-0761-2026 · Official record ↗

FDA Class II · Food · May 13, 2026

Chocolate Showers Ice Cream - 32 oz (5 labels recall — Silver Moon LP dba Loard's Ice Cream

Undeclared Soy (with mitigating circumstances)

Company / brand: Silver Moon LP dba Loard's Ice Cream recalls

Official ID H-0760-2026 · Official record ↗

FDA Class III · Food · May 13, 2026

Peppermint Ice Cream - 32 oz (4 labels recall — Silver Moon LP dba Loard's Ice Cream

Undeclared Red #40

Company / brand: Silver Moon LP dba Loard's Ice Cream recalls

Official ID H-0759-2026 · Official record ↗

FDA Class II · Food · May 13, 2026

Chocolate Mint Ice Cream - 32 oz (4 labels recall — Silver Moon LP dba Loard's Ice Cream

Undeclared Soy (with mitigating circumstances), Yellow #5, Blue #1

Company / brand: Silver Moon LP dba Loard's Ice Cream recalls

Official ID H-0758-2026 · Official record ↗

FDA Class III · Food · May 13, 2026

Burgundy Cherry Ice Cream - 32 oz (4 labels recall — Silver Moon LP dba Loard's Ice Cream

Undeclared Red #40, Blue #1, Blue #2

Company / brand: Silver Moon LP dba Loard's Ice Cream recalls

Official ID H-0757-2026 · Official record ↗

FDA Class II · Food · May 13, 2026

Banana Ice Cream - 32 oz (4 labels recall — Silver Moon LP dba Loard's Ice Cream

Undeclared Yellow #5

Company / brand: Silver Moon LP dba Loard's Ice Cream recalls

Official ID H-0756-2026 · Official record ↗

FDA Class II · Food · May 13, 2026

Loard's Vanilla Ice Cream - 32 oz recall — Silver Moon LP dba Loard's Ice Cream

Undeclared Milk.

Company / brand: Silver Moon LP dba Loard's Ice Cream recalls

Official ID H-0755-2026 · Official record ↗

FDA Class II · Food · May 13, 2026

Loard's Ube Ice Cream - 32 oz recall — Silver Moon LP dba Loard's Ice Cream

Undeclared Milk, Red #3, Red #40, Blue #1, Blue #2.

Company / brand: Silver Moon LP dba Loard's Ice Cream recalls

Official ID H-0754-2026 · Official record ↗

FDA Class II · Food · May 13, 2026

Loard's Toasted Almond Ice Cream - 32 oz recall — Silver Moon LP dba Loard's Ice Cream

Undeclared Milk, Almonds.

Company / brand: Silver Moon LP dba Loard's Ice Cream recalls

Official ID H-0753-2026 · Official record ↗

FDA Class II · Food · May 13, 2026

Loard's Strawberry Ice Cream - 32 oz recall — Silver Moon LP dba Loard's Ice Cream

Undeclared Milk, Red #40.

Company / brand: Silver Moon LP dba Loard's Ice Cream recalls

Official ID H-0752-2026 · Official record ↗

FDA Class II · Food · May 13, 2026

Loard's Sea Salt Caramel Ice Cream - 32 oz recall — Silver Moon LP dba Loard's Ice Cream

Undeclared Milk, Soy, Sulfites.

Company / brand: Silver Moon LP dba Loard's Ice Cream recalls

Official ID H-0751-2026 · Official record ↗

FDA Class II · Food · May 13, 2026

Loard's Rocky Road Ice Cream - 56 oz recall — Silver Moon LP dba Loard's Ice Cream

Undeclared Milk, Walnuts, Eggs.

Company / brand: Silver Moon LP dba Loard's Ice Cream recalls

Official ID H-0750-2026 · Official record ↗

FDA Class II · Food · May 13, 2026

Loard's Raspberry Sherbert - 32 oz recall — Silver Moon LP dba Loard's Ice Cream

Undeclared Milk, Red #40.

Company / brand: Silver Moon LP dba Loard's Ice Cream recalls

Official ID H-0749-2026 · Official record ↗

FDA Class II · Food · May 13, 2026

Loard's Rainbow Sherbert - 32 oz recall — Silver Moon LP dba Loard's Ice Cream

Undeclared Milk, Soy, Yellow #5, Red #40, Green #3.

Company / brand: Silver Moon LP dba Loard's Ice Cream recalls

Official ID H-0748-2026 · Official record ↗

FDA Class II · Food · May 13, 2026

Loard's Pumpkin Ice Cream - 32 oz recall — Silver Moon LP dba Loard's Ice Cream

Undeclared Milk, Yellow #6.

Company / brand: Silver Moon LP dba Loard's Ice Cream recalls

Official ID H-0747-2026 · Official record ↗

FDA Class II · Food · May 13, 2026

Loard's Pistachio Ice Cream - 32 oz recall — Silver Moon LP dba Loard's Ice Cream

Undeclared Milk, Pistachios, Yellow #5, Blue #1.

Company / brand: Silver Moon LP dba Loard's Ice Cream recalls

Official ID H-0746-2026 · Official record ↗

FDA Class II · Food · May 13, 2026

Loard's Peppermint Ice Cream - 32 oz recall — Silver Moon LP dba Loard's Ice Cream

Undeclared Milk, Soy, Red #40.

Company / brand: Silver Moon LP dba Loard's Ice Cream recalls

Official ID H-0745-2026 · Official record ↗

FDA Class II · Food · May 13, 2026

Loard's Pecan Praline Ice Cream - 32 oz recall — Silver Moon LP dba Loard's Ice Cream

Undeclared Milk, Pecans.

Company / brand: Silver Moon LP dba Loard's Ice Cream recalls

Official ID H-0744-2026 · Official record ↗

FDA Class II · Food · May 13, 2026

Loard's Peanut Butter Fudge Ice Cream - 32 oz recall — Silver Moon LP dba Loard's Ice Cream

Undeclared Milk, Peanuts.

Company / brand: Silver Moon LP dba Loard's Ice Cream recalls

Official ID H-0743-2026 · Official record ↗

FDA Class II · Food · May 13, 2026

Loard's Orange Sherbert - 32 oz recall — Silver Moon LP dba Loard's Ice Cream

Undeclared Milk, Yellow #5.

Company / brand: Silver Moon LP dba Loard's Ice Cream recalls

Official ID H-0742-2026 · Official record ↗

FDA Class II · Food · May 13, 2026

Loard's Mocha Chip Ice Cream - 32 oz recall — Silver Moon LP dba Loard's Ice Cream

Undeclared Milk.

Company / brand: Silver Moon LP dba Loard's Ice Cream recalls

Official ID H-0741-2026 · Official record ↗

FDA Class II · Food · May 13, 2026

Loard's Mocha Almond Fudge Ice Cream - 32 oz recall — Silver Moon LP dba Loard's Ice Cream

Undeclared Milk, Almonds, Soy.

Company / brand: Silver Moon LP dba Loard's Ice Cream recalls

Official ID H-0740-2026 · Official record ↗

FDA Class II · Food · May 13, 2026

Loard's Maple Walnut Ice Cream - 32 oz recall — Silver Moon LP dba Loard's Ice Cream

Undeclared Milk, Walnuts, Sulfites.

Company / brand: Silver Moon LP dba Loard's Ice Cream recalls

Official ID H-0739-2026 · Official record ↗

FDA Class II · Food · May 13, 2026

Loard's Mango Ice Cream - 32 oz recall — Silver Moon LP dba Loard's Ice Cream

Undeclared Milk, Yellow #5.

Company / brand: Silver Moon LP dba Loard's Ice Cream recalls

Official ID H-0738-2026 · Official record ↗

FDA Class II · Food · May 13, 2026

Loard's Lime Sherbert - 32 oz recall — Silver Moon LP dba Loard's Ice Cream

Undeclared Milk, Wheat, Soy, Yellow #5, Green #3.

Company / brand: Silver Moon LP dba Loard's Ice Cream recalls

Official ID H-0737-2026 · Official record ↗

FDA Class II · Food · May 13, 2026

Loard's Lemon Chiffon Ice Cream - 32 oz recall — Silver Moon LP dba Loard's Ice Cream

Undeclared Milk, Eggs, Yellow #5.

Company / brand: Silver Moon LP dba Loard's Ice Cream recalls

Official ID H-0736-2026 · Official record ↗

FDA Class II · Food · May 13, 2026

Loard's Horchata Ice Cream - 32 oz recall — Silver Moon LP dba Loard's Ice Cream

Undeclared Milk, Soy.

Company / brand: Silver Moon LP dba Loard's Ice Cream recalls

Official ID H-0735-2026 · Official record ↗

FDA Class II · Food · May 13, 2026

Loard's Green Tea Ice Cream - 32 oz recall — Silver Moon LP dba Loard's Ice Cream

Undeclared Milk, Yellow #5.

Company / brand: Silver Moon LP dba Loard's Ice Cream recalls

Official ID H-0734-2026 · Official record ↗

FDA Class II · Food · May 13, 2026

Loard's Egg Nog Ice Cream - 32 oz recall — Silver Moon LP dba Loard's Ice Cream

Undeclared Milk, Eggs, Yellow #5.

Company / brand: Silver Moon LP dba Loard's Ice Cream recalls

Official ID H-0733-2026 · Official record ↗

FDA Class II · Food · May 13, 2026

Loard's Cookies and Cream Ice Cream - 32 oz recall — Silver Moon LP dba Loard's Ice Cream

Undeclared Milk, Wheat, Soy.

Company / brand: Silver Moon LP dba Loard's Ice Cream recalls

Official ID H-0732-2026 · Official record ↗

FDA Class II · Food · May 13, 2026

Loard's Coffee Ice Cream - 32 oz recall — Silver Moon LP dba Loard's Ice Cream

Undeclared Milk.

Company / brand: Silver Moon LP dba Loard's Ice Cream recalls

Official ID H-0731-2026 · Official record ↗

FDA Class II · Food · May 13, 2026

Loard's Coconut Pineapple Ice Cream - 32 oz recall — Silver Moon LP dba Loard's Ice Cream

Undeclared Milk.

Company / brand: Silver Moon LP dba Loard's Ice Cream recalls

Official ID H-0730-2026 · Official record ↗

FDA Class II · Food · May 13, 2026

Loard's Chocolate Ice Cream - 32 oz recall — Silver Moon LP dba Loard's Ice Cream

Undeclared Milk.

Company / brand: Silver Moon LP dba Loard's Ice Cream recalls

Official ID H-0729-2026 · Official record ↗

FDA Class II · Food · May 13, 2026

Loard's Chocolate Showers Ice Cream - 32 oz recall — Silver Moon LP dba Loard's Ice Cream

Undeclared Milk, Soy.

Company / brand: Silver Moon LP dba Loard's Ice Cream recalls

Official ID H-0728-2026 · Official record ↗

FDA Class II · Food · May 13, 2026

Loard's Chocolate Mint Ice Cream - 32 oz recall — Silver Moon LP dba Loard's Ice Cream

Undeclared Milk, Soy, Yellow #5, Blue #1.

Company / brand: Silver Moon LP dba Loard's Ice Cream recalls

Official ID H-0727-2026 · Official record ↗

FDA Class II · Food · May 13, 2026

Loard's Chocolate Marble Ice Cream - 32 oz recall — Silver Moon LP dba Loard's Ice Cream

Undeclared Milk.

Company / brand: Silver Moon LP dba Loard's Ice Cream recalls

Official ID H-0726-2026 · Official record ↗

FDA Class II · Food · May 13, 2026

Loard's Cherry Vanilla Ice Cream - 32 oz recall — Silver Moon LP dba Loard's Ice Cream

Undeclared Milk, Red #40.

Company / brand: Silver Moon LP dba Loard's Ice Cream recalls

Official ID H-0725-2026 · Official record ↗

FDA Class II · Food · May 13, 2026

Loard's Champagne Sherbert - 32 oz recall — Silver Moon LP dba Loard's Ice Cream

Undeclared Milk, Red #40.

Company / brand: Silver Moon LP dba Loard's Ice Cream recalls

Official ID H-0724-2026 · Official record ↗

FDA Class II · Food · May 13, 2026

Loard's Caramel Cashew Ice Cream - 32 oz recall — Silver Moon LP dba Loard's Ice Cream

Undeclared Milk, Cashews, Soy, Sulfites.

Company / brand: Silver Moon LP dba Loard's Ice Cream recalls

Official ID H-0723-2026 · Official record ↗

FDA Class II · Food · May 13, 2026

Loard's Butterscotch Marble Ice Cream - 32 oz recall — Silver Moon LP dba Loard's Ice Cream

Undeclared Milk.

Company / brand: Silver Moon LP dba Loard's Ice Cream recalls

Official ID H-0722-2026 · Official record ↗

FDA Class II · Food · May 13, 2026

Loard's Butter Brickle Ice Cream - 32 oz recall — Silver Moon LP dba Loard's Ice Cream

Undeclared Milk, Almonds, Soy.

Company / brand: Silver Moon LP dba Loard's Ice Cream recalls

Official ID H-0721-2026 · Official record ↗

FDA Class II · Food · May 13, 2026

Loard's Burgundy Cherry Ice Cream - 32 oz recall — Silver Moon LP dba Loard's Ice Cream

Undeclared Milk, Red #40, Blue #1, Blue #2.

Company / brand: Silver Moon LP dba Loard's Ice Cream recalls

Official ID H-0720-2026 · Official record ↗

FDA Class II · Food · May 13, 2026

Loard's Brownie Nut Fudge Ice Cream - 32 oz recall — Silver Moon LP dba Loard's Ice Cream

Undeclared Milk, Walnuts, Eggs, Wheat, Soy.

Company / brand: Silver Moon LP dba Loard's Ice Cream recalls

Official ID H-0719-2026 · Official record ↗

FDA Class II · Food · May 13, 2026

Loard's Blueberry Cheesecake Ice Cream - 32 oz recall — Silver Moon LP dba Loard's Ice Cream

Undeclared Milk, Red #40, Blue #1.

Company / brand: Silver Moon LP dba Loard's Ice Cream recalls

Official ID H-0718-2026 · Official record ↗

FDA Class II · Food · May 13, 2026

Loard's Black Walnut Ice Cream - 32 oz recall — Silver Moon LP dba Loard's Ice Cream

Undeclared Milk, Walnuts.

Company / brand: Silver Moon LP dba Loard's Ice Cream recalls

Official ID H-0717-2026 · Official record ↗

FDA Class II · Food · May 13, 2026

Loard's Black Raspberry Ice Cream - 32 oz recall — Silver Moon LP dba Loard's Ice Cream

Undeclared Milk, Red #40, Blue #1.

Company / brand: Silver Moon LP dba Loard's Ice Cream recalls

Official ID H-0716-2026 · Official record ↗

FDA Class II · Food · May 13, 2026

Loard's Black Raspberry Marble Ice Cream - 32 oz recall — Silver Moon LP dba Loard's Ice Cream

Undeclared Milk, Red #40, Blue #1.

Company / brand: Silver Moon LP dba Loard's Ice Cream recalls

Official ID H-0715-2026 · Official record ↗

FDA Class II · Food · May 13, 2026

Loard's Banana Ice Cream - 32 oz recall — Silver Moon LP dba Loard's Ice Cream

Undeclared Milk, Yellow #5.

Company / brand: Silver Moon LP dba Loard's Ice Cream recalls

Official ID H-0714-2026 · Official record ↗

FDA Class II · Food · May 13, 2026

Loard's Almond Joy Ice Cream - 32 oz recall — Silver Moon LP dba Loard's Ice Cream

Undeclared Milk, Almonds, Soy, Sulfites.

Company / brand: Silver Moon LP dba Loard's Ice Cream recalls

Official ID H-0713-2026 · Official record ↗

FDA Class I · Food · May 13, 2026

french broad CHOCOLATE bette's bake sale (a multi-flavor bonbon assortment) recall — French Broad Chocolate Factory

Undeclared nut allergen (walnut) due to mislabeling. The product's printed tasting guide incorrectly identifies the Walnut Fudge and Peach Cobbler flavor chocolates (bonbons). Cons…

Company / brand: French Broad Chocolate Factory recalls

Official ID H-0712-2026 · Official record ↗

FDA Class II · Food · May 13, 2026

Horizon Organic Chocolate Organic Lowfat Milk recall — Horizon Organic Dairy, LLC

Package integrity compromised.

Company / brand: Horizon Organic Dairy recalls

Official ID H-0711-2026 · Official record ↗

FDA Class II · Food · May 13, 2026

Hatch Green Chile Creamed Honey 671333101339 * These product labels may also say Whipped H recall — Walker Honey Co

Creamed honey products may contain stainless steel dust/flakes and/or small particles or shreds of plastic.

Company / brand: Walker Honey Co recalls

Official ID H-0710-2026 · Official record ↗

FDA Class II · Food · May 13, 2026

Darkside of the Hive Creamed Honey/Salted Chocolate Creamed Honey 671333101414 *These prod recall — Walker Honey Co

Creamed honey products may contain stainless steel dust/flakes and/or small particles or shreds of plastic.

Company / brand: Walker Honey Co recalls

Official ID H-0709-2026 · Official record ↗

FDA Class II · Food · May 13, 2026

Natural Creamed Honey recall — Walker Honey Co

Creamed honey products may contain stainless steel dust/flakes and/or small particles or shreds of plastic.

Company / brand: Walker Honey Co recalls

Official ID H-0708-2026 · Official record ↗

FDA Class II · Food · May 13, 2026

Lemon Creamed Honey recall — Walker Honey Co

Creamed honey products may contain stainless steel dust/flakes and/or small particles or shreds of plastic.

Company / brand: Walker Honey Co recalls

Official ID H-0707-2026 · Official record ↗

FDA Class II · Food · May 13, 2026

Hatch Creamed Honey 671333101339 * These product labels may also say Whipped Honey instead recall — Walker Honey Co

Creamed honey products may contain stainless steel dust/flakes and/or small particles or shreds of plastic.

Company / brand: Walker Honey Co recalls

Official ID H-0706-2026 · Official record ↗

FDA Class II · Food · May 13, 2026

Dark Pecan Creamed Honey/Pecan Creamed Honey 671333101407 * These product labels may also recall — Walker Honey Co

Creamed honey products may contain stainless steel dust/flakes and/or small particles or shreds of plastic.

Company / brand: Walker Honey Co recalls

Official ID H-0705-2026 · Official record ↗

FDA Class II · Food · May 13, 2026

Cinnamon Creamed Honey 671333101360 * These product labels may also say Whipped Honey inst recall — Walker Honey Co

Creamed honey products may contain stainless steel dust/flakes and/or small particles or shreds of plastic.

Company / brand: Walker Honey Co recalls

Official ID H-0704-2026 · Official record ↗

FDA Class II · Food · May 13, 2026

Blackberry Creamed Honey 671333101308 * These product labels may also say Whipped Honey in recall — Walker Honey Co

Creamed honey products may contain stainless steel dust/flakes and/or small particles or shreds of plastic.

Company / brand: Walker Honey Co recalls

Official ID H-0703-2026 · Official record ↗

FDA Class II · Food · May 13, 2026

Raspberry Creamed Honey 671333101322 ¿ These product labels may also say Whipped Honey ins recall — Walker Honey Co

Creamed honey products may contain stainless steel dust/flakes and/or small particles or shreds of plastic.

Company / brand: Walker Honey Co recalls

Official ID H-0702-2026 · Official record ↗

FDA Class II · Food · May 13, 2026

Fain s Blackberry Honey Spread recall — Walker Honey Co

Creamed honey products may contain stainless steel dust/flakes and/or small particles or shreds of plastic.

Company / brand: Walker Honey Co recalls

Official ID H-0701-2026 · Official record ↗

FDA Class I · Food · May 13, 2026

Buttermilk Powder - paper bags 25 kg recall — California Dairies Inc.

Potential contamination with Salmonella.

Company / brand: California Dairies recalls

Official ID H-0700-2026 · Official record ↗

FDA Class I · Food · May 13, 2026

Low Heat Non-Fat Dried Milk Powder - paper bags 25 kg recall — California Dairies Inc.

Potential contamination with Salmonella.

Company / brand: California Dairies recalls

Official ID H-0699-2026 · Official record ↗

FDA Class I · Food · May 13, 2026

Low Heat Non-Fat Dried Milk Powder - plastic totes (NTE) 2200 lbs recall — California Dairies Inc.

Potential contamination with Salmonella.

Company / brand: California Dairies recalls

Official ID H-0698-2026 · Official record ↗

FDA Class III · Food · May 13, 2026

SunRidge Farms Organic SUNSET SOUP MIX CERTIFIED ORGANIC BY QAI NET WT recall — Falcon Trading Co., Inc.

Potential contamination with pesticides, haloxyfop and thiamethoxam

Company / brand: Falcon Trading Co recalls

Official ID H-0697-2026 · Official record ↗

FDA Class III · Food · May 13, 2026

SunRidge Farms Organic CHILI BEAN BLEND CERTIFIED ORGANIC BY QAI NET WT recall — Falcon Trading Co., Inc.

Potential contamination with pesticides, haloxyfop and thiamethoxam

Company / brand: Falcon Trading Co recalls

Official ID H-0696-2026 · Official record ↗

FDA Class III · Food · May 13, 2026

SunRidge Farms Organic Black Beans CERTIFIED ORGANIC BY QAI NET WT recall — Falcon Trading Co., Inc.

Potential contamination with pesticides, haloxyfop and thiamethoxam

Company / brand: Falcon Trading Co recalls

Official ID H-0695-2026 · Official record ↗

FDA Class II · Food · May 13, 2026

Woodstock Organic Shelled Edamame 10 oz recall — Green Organic Vegetables

Foreign object: metal pieces

Company / brand: Green Organic Vegetables recalls

Official ID H-0694-2026 · Official record ↗

FDA Class I · Food · May 13, 2026

MILK-N-EGG MIX NET WEIGHT recall — Griffith Foods Inc.

Potential Salmonella contamination. The firm was notified from their supplier that the nonfat dry milk may be contaminated with Salmonella.

Company / brand: Griffith Foods recalls

Official ID H-0693-2026 · Official record ↗

FDA Class I · Food · May 13, 2026

MILK WASH NET WEIGHT recall — Griffith Foods Inc.

Potential Salmonella contamination. The firm was notified from their supplier that the nonfat dry milk may be contaminated with Salmonella.

Company / brand: Griffith Foods recalls

Official ID H-0692-2026 · Official record ↗

FDA Class I · Food · May 13, 2026

Costco Service Deli Department 63 MEATLOAF SEASONING MORE FLV Pack Size recall — Griffith Foods Inc.

Potential Salmonella contamination. The firm was notified from their supplier that the nonfat dry milk may be contaminated with Salmonella.

Company / brand: Griffith Foods recalls

Official ID H-0691-2026 · Official record ↗

FDA Class II · Food · May 13, 2026

Montebianco recall — Disaronno Ingredients S.p.a.

Undeclared allergen Milk. The presence of the milk allergen in the product was found to exceed acceptable levels despite the product being labeled with the statement *May contain m…

Company / brand: Disaronno Ingredients S.p.a recalls

Official ID H-0690-2026 · Official record ↗

FDA Class II · Food · May 13, 2026

XZL recall — SUNGAL INC

Product Contains undeclared FD&C Yellow #5 & #6 and Red #40

Company / brand: SUNGAL recalls

Official ID H-0689-2026 · Official record ↗

FDA Class III · Food · May 13, 2026

Christopher Ranch Peeled Garlic 6 oz recall — Tops Markets LLC

The potential contamination with Clostridium botulinum, due to risk of temperature abuse during chilled storage at the firm

Company / brand: Tops Markets recalls

Official ID H-0688-2026 · Official record ↗

FDA Class III · Food · May 13, 2026

Garland Fresh Peeled Garlic 6 oz recall — Tops Markets LLC

The potential contamination with Clostridium botulinum, due to risk of temperature abuse during chilled storage at the firm

Company / brand: Tops Markets recalls

Official ID H-0687-2026 · Official record ↗

FDA Class I · Drug · May 13, 2026

Lactated Ringer's Injection USP recall — B BRAUN MEDICAL INC

Presence of Particulate Matter.

Company / brand: B BRAUN MEDICAL recalls

Official ID D-0540-2026 · Official record ↗

FDA Class II · Drug · May 13, 2026

TPN bag (patient specific) recall — Central Admixture Pharmacy Services, Inc (CAPS) Los Angeles

Incorrect Product Formulation: product did not contain insulin as listed in the label.

Company / brand: Central Admixture Pharmacy Services recalls

Official ID D-0524-2026 · Official record ↗

FDA Class II · Drug · May 13, 2026

NAPROXEN ORAL SUSPENSION recall — Acella Pharmaceuticals, LLC

Chemical contamination; presence of lead and lithium above specification

Company / brand: Acella Pharmaceuticals recalls

Official ID D-0523-2026 · Official record ↗

FDA Class II · Drug · May 13, 2026

Duloxetine Delayed-Release Capsules USP recall — Breckenridge Pharmaceutical, Inc.

CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit

Company / brand: Breckenridge Pharmaceutical recalls

Official ID D-0522-2026 · Official record ↗

FDA Class II · Drug · May 13, 2026

Enalapril Maleate Tablets recall — JB Chemicals and Pharmaceuticals Ltd

Failed Impurities/Degradation Specifications:Out of specification result occurred in Organic Impurities Test

Company / brand: JB Chemicals and Pharmaceuticals recalls

Official ID D-0520-2026 · Official record ↗

FDA Class II · Drug · May 13, 2026

Octreotide Acetate for Injectable Suspension recall — Teva Pharmaceuticals USA, Inc

Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and Drug Administration (FDA) inspection at the contract manufacturer.

Company / brand: Teva Pharmaceuticals USA recalls

Official ID D-0519-2026 · Official record ↗

FDA Class II · Drug · May 13, 2026

BD PurPrep recall — CareFusion 213, LLC

Lack of assurance of Sterility: potential product contamination

Company / brand: CareFusion 213 recalls

Official ID D-0518-2026 · Official record ↗

FDA Class II · Drug · May 13, 2026

BD PurPrep recall — CareFusion 213, LLC

Lack of assurance of Sterility: potential product contamination

Company / brand: CareFusion 213 recalls

Official ID D-0517-2026 · Official record ↗

FDA Class II · Drug · May 13, 2026

Duloxetine Delayed-Release Capsules recall — Ajanta Pharma Ltd.

CGMP Deviations: Presence of N-nitroso-Duloxetine impurity above FDA recommended limit of 0.83 ppm, identified at the 12-month and 18-month long-term stability intervals.

Company / brand: Ajanta Pharma recalls

Official ID D-0516-2026 · Official record ↗

FDA Class II · Drug · May 13, 2026

Duloxetine Delayed-Release Capsules recall — Ajanta Pharma Ltd.

CGMP Deviations: Presence of N-nitroso-Duloxetine impurity above FDA recommended limit of 0.83 ppm, identified at the 12-month and 18-month long-term stability intervals.

Company / brand: Ajanta Pharma recalls

Official ID D-0515-2026 · Official record ↗

FDA Class II · Drug · May 13, 2026

Duloxetine Delayed-Release Capsules recall — Ajanta Pharma Ltd.

CGMP Deviations: Presence of N-nitroso-Duloxetine impurity above FDA recommended limit of 0.83 ppm, identified at the 12-month and 18-month long-term stability intervals.

Company / brand: Ajanta Pharma recalls

Official ID D-0514-2026 · Official record ↗

FDA Class II · Drug · May 13, 2026

DELFLEX recall — Fresenius Medical Care Holdings, Inc.

Lack of Assurance of Sterility: Potential leaks from perforations in bags.

Company / brand: Fresenius Medical Care Holdings recalls

Official ID D-0513-2026 · Official record ↗

FDA Class II · Drug · May 13, 2026

DELFLEX recall — Fresenius Medical Care Holdings, Inc.

Lack of Assurance of Sterility: Potential leaks from perforations in bags.

Company / brand: Fresenius Medical Care Holdings recalls

Official ID D-0512-2026 · Official record ↗

FDA Class III · Drug · May 13, 2026

busPIRone Hydrochloride Tablets recall — Unichem Pharmaceuticals USA Inc.

Subpotent drug

Company / brand: Unichem Pharmaceuticals USA recalls

Official ID D-0511-2026 · Official record ↗

FDA Class II · Medical device · May 6, 2026

Medline and Centurion medical convenience kits recall — Medline Industries, LP

Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing Cardinal Health Webcol Large Alcohol Prep Pads. Cardinal Health has deemed Web…

Company / brand: Medline Industries recalls

Official ID Z-2045-2026 · Official record ↗

FDA Class II · Medical device · May 6, 2026

Centurion medical convenience kits recall — Medline Industries, LP

Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing Cardinal Health Webcol Large Alcohol Prep Pads. Cardinal Health has deemed Web…

Company / brand: Medline Industries recalls

Official ID Z-2044-2026 · Official record ↗

FDA Class II · Medical device · May 6, 2026

Medline or Centurion medical convenience kits recall — Medline Industries, LP

Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing Cardinal Health Webcol Large Alcohol Prep Pads. Cardinal Health has deemed Web…

Company / brand: Medline Industries recalls

Official ID Z-2043-2026 · Official record ↗

FDA Class II · Medical device · May 6, 2026

Centurion medical convenience kits recall — Medline Industries, LP

Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing Cardinal Health Webcol Large Alcohol Prep Pads. Cardinal Health has deemed Web…

Company / brand: Medline Industries recalls

Official ID Z-2042-2026 · Official record ↗

FDA Class II · Medical device · May 6, 2026

Medline and Centurion medical convenience kits recall — Medline Industries, LP

Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing Cardinal Health Webcol Large Alcohol Prep Pads. Cardinal Health has deemed Web…

Company / brand: Medline Industries recalls

Official ID Z-2041-2026 · Official record ↗

FDA Class II · Medical device · May 6, 2026

Medline medical convenience kits recall — Medline Industries, LP

Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing Cardinal Health Webcol Large Alcohol Prep Pads. Cardinal Health has deemed Web…

Company / brand: Medline Industries recalls

Official ID Z-2040-2026 · Official record ↗

FDA Class II · Medical device · May 6, 2026

Centurion medical convenience kits recall — Medline Industries, LP

Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing Cardinal Health Webcol Large Alcohol Prep Pads. Cardinal Health has deemed Web…

Company / brand: Medline Industries recalls

Official ID Z-2039-2026 · Official record ↗

FDA Class II · Medical device · May 6, 2026

Medline medical procedure kits recall — Medline Industries, LP

During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-o…

Company / brand: Medline Industries recalls

Official ID Z-2038-2026 · Official record ↗

FDA Class II · Medical device · May 6, 2026

Medline medical procedure kits recall — Medline Industries, LP

During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-o…

Company / brand: Medline Industries recalls

Official ID Z-2037-2026 · Official record ↗

FDA Class II · Medical device · May 6, 2026

Medline medical procedure kits recall — Medline Industries, LP

During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-o…

Company / brand: Medline Industries recalls

Official ID Z-2036-2026 · Official record ↗

FDA Class II · Medical device · May 6, 2026

Medline medical procedure kits recall — Medline Industries, LP

During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-o…

Company / brand: Medline Industries recalls

Official ID Z-2035-2026 · Official record ↗

FDA Class II · Medical device · May 6, 2026

Medline medical procedure kits recall — Medline Industries, LP

During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-o…

Company / brand: Medline Industries recalls

Official ID Z-2034-2026 · Official record ↗

FDA Class II · Medical device · May 6, 2026

Medline medical procedure kits recall — Medline Industries, LP

During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-o…

Company / brand: Medline Industries recalls

Official ID Z-2033-2026 · Official record ↗

FDA Class II · Medical device · May 6, 2026

Medline medical procedure kits recall — Medline Industries, LP

During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-o…

Company / brand: Medline Industries recalls

Official ID Z-2032-2026 · Official record ↗

FDA Class II · Medical device · May 6, 2026

Medline medical procedure kits recall — Medline Industries, LP

During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-o…

Company / brand: Medline Industries recalls

Official ID Z-2031-2026 · Official record ↗

FDA Class II · Medical device · May 6, 2026

Medline medical procedure kits recall — Medline Industries, LP

During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-o…

Company / brand: Medline Industries recalls

Official ID Z-2030-2026 · Official record ↗

FDA Class II · Medical device · May 6, 2026

Medline medical procedure kits recall — Medline Industries, LP

During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-o…

Company / brand: Medline Industries recalls

Official ID Z-2029-2026 · Official record ↗

FDA Class II · Medical device · May 6, 2026

Centurion medical procedure kits recall — Medline Industries, LP

During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-o…

Company / brand: Medline Industries recalls

Official ID Z-2028-2026 · Official record ↗

FDA Class II · Medical device · May 6, 2026

Medline medical procedure kits recall — Medline Industries, LP

During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-o…

Company / brand: Medline Industries recalls

Official ID Z-2027-2026 · Official record ↗

FDA Class II · Medical device · May 6, 2026

Medline medical procedure kits recall — Medline Industries, LP

During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-o…

Company / brand: Medline Industries recalls

Official ID Z-2026-2026 · Official record ↗

FDA Class II · Medical device · May 6, 2026

Medline medical procedure kits recall — Medline Industries, LP

During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-o…

Company / brand: Medline Industries recalls

Official ID Z-2025-2026 · Official record ↗

FDA Class II · Medical device · May 6, 2026

Medline medical procedure kits recall — Medline Industries, LP

During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-o…

Company / brand: Medline Industries recalls

Official ID Z-2024-2026 · Official record ↗

FDA Class II · Medical device · May 6, 2026

Medline medical procedure kits recall — Medline Industries, LP

During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-o…

Company / brand: Medline Industries recalls

Official ID Z-2023-2026 · Official record ↗

FDA Class II · Medical device · May 6, 2026

Medline medical procedure kits recall — Medline Industries, LP

During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-o…

Company / brand: Medline Industries recalls

Official ID Z-2022-2026 · Official record ↗

FDA Class II · Medical device · May 6, 2026

Medline and Centurion medical procedure kits recall — Medline Industries, LP

During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-o…

Company / brand: Medline Industries recalls

Official ID Z-2021-2026 · Official record ↗

FDA Class II · Medical device · May 6, 2026

Medline medical procedure kits recall — Medline Industries, LP

During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-o…

Company / brand: Medline Industries recalls

Official ID Z-2020-2026 · Official record ↗

FDA Class II · Medical device · May 6, 2026

Medline medical procedure kits recall — Medline Industries, LP

During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-o…

Company / brand: Medline Industries recalls

Official ID Z-2019-2026 · Official record ↗

FDA Class II · Medical device · May 6, 2026

Medline medical procedure kits recall — Medline Industries, LP

During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-o…

Company / brand: Medline Industries recalls

Official ID Z-2018-2026 · Official record ↗

FDA Class II · Medical device · May 6, 2026

Medline medical procedure kits recall — Medline Industries, LP

During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-o…

Company / brand: Medline Industries recalls

Official ID Z-2017-2026 · Official record ↗

FDA Class II · Medical device · May 6, 2026

Medline medical procedure kits recall — Medline Industries, LP

During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-o…

Company / brand: Medline Industries recalls

Official ID Z-2016-2026 · Official record ↗

FDA Class II · Medical device · May 6, 2026

Medline medical procedure kits recall — Medline Industries, LP

During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-o…

Company / brand: Medline Industries recalls

Official ID Z-2015-2026 · Official record ↗

FDA Class II · Medical device · May 6, 2026

Medline medical procedure kits recall — Medline Industries, LP

During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-o…

Company / brand: Medline Industries recalls

Official ID Z-2014-2026 · Official record ↗

FDA Class II · Medical device · May 6, 2026

Medline medical procedure kits recall — Medline Industries, LP

During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-o…

Company / brand: Medline Industries recalls

Official ID Z-2013-2026 · Official record ↗

FDA Class II · Medical device · May 6, 2026

Medline medical procedure kits recall — Medline Industries, LP

During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-o…

Company / brand: Medline Industries recalls

Official ID Z-2012-2026 · Official record ↗

FDA Class II · Medical device · May 6, 2026

Medline medical procedure kits recall — Medline Industries, LP

During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-o…

Company / brand: Medline Industries recalls

Official ID Z-2011-2026 · Official record ↗

FDA Class II · Medical device · May 6, 2026

Medline medical procedure kits recall — Medline Industries, LP

During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-o…

Company / brand: Medline Industries recalls

Official ID Z-2010-2026 · Official record ↗

FDA Class II · Medical device · May 6, 2026

Medline medical procedure kits recall — Medline Industries, LP

During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-o…

Company / brand: Medline Industries recalls

Official ID Z-2009-2026 · Official record ↗

FDA Class II · Medical device · May 6, 2026

Medline Neuro Sponges recall — Medline Industries, LP

During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-o…

Company / brand: Medline Industries recalls

Official ID Z-2008-2026 · Official record ↗

FDA Class II · Medical device · May 6, 2026

Brand Name recall — Elekta, Inc.

Locking mechanisms may not properly secure to the Arc system, resulting in shifting of coordinates during procedures.

Company / brand: Elekta recalls

Official ID Z-2006-2026 · Official record ↗

FDA Class II · Medical device · May 6, 2026

epoc BGEM BUN Test Card (25 pk) for the epoc Blood Analysis System recall — Siemens Healthcare Diagnostics Inc

Use of the affected product can result in discrepant low pH and measured Total Carbon Dioxide (mTCO2) results and corresponding calculated values in arterial, venous, and capillary…

Company / brand: Siemens Healthcare Diagnostics recalls

Official ID Z-2005-2026 · Official record ↗

FDA Class II · Medical device · May 6, 2026

Philips Bridge Prep Kit REF recall — Merit Medical Systems, Inc.

catheter may experience resistance when being advanced over the guidewire

Company / brand: Merit Medical Systems recalls

Official ID Z-2004-2026 · Official record ↗

FDA Class II · Medical device · May 6, 2026

Philips Bridge Prep Kit REF recall — Merit Medical Systems, Inc.

catheter may experience resistance when being advanced over the guidewire

Company / brand: Merit Medical Systems recalls

Official ID Z-2003-2026 · Official record ↗

FDA Class II · Medical device · May 6, 2026

Philips Bridge Prep Kit REF recall — Merit Medical Systems, Inc.

catheter may experience resistance when being advanced over the guidewire

Company / brand: Merit Medical Systems recalls

Official ID Z-2002-2026 · Official record ↗

FDA Class II · Medical device · May 6, 2026

i-STAT G3+ cartridge recall — Abbott Point Of Care Inc.

Approximately 7.6% of cartridges from specific i-STAT EG7+ (list number 03P76-25), i-STAT EG6+ (list number 03P77-25) and i-STAT G3+ (list number 03P78-26) cartridge lots in the U.…

Company / brand: Abbott Point Of Care recalls

Official ID Z-2001-2026 · Official record ↗

FDA Class II · Medical device · May 6, 2026

i-STAT EG6+ cartridge recall — Abbott Point Of Care Inc.

Approximately 7.6% of cartridges from specific i-STAT EG7+ (list number 03P76-25), i-STAT EG6+ (list number 03P77-25) and i-STAT G3+ (list number 03P78-26) cartridge lots in the U.…

Company / brand: Abbott Point Of Care recalls

Official ID Z-2000-2026 · Official record ↗

FDA Class II · Medical device · May 6, 2026

i-STAT EG7+ cartridge recall — Abbott Point Of Care Inc.

Approximately 7.6% of cartridges from specific i-STAT EG7+ (list number 03P76-25), i-STAT EG6+ (list number 03P77-25) and i-STAT G3+ (list number 03P78-26) cartridge lots in the U.…

Company / brand: Abbott Point Of Care recalls

Official ID Z-1999-2026 · Official record ↗

FDA Class III · Medical device · May 6, 2026

Heraeus recall — Heraeus Medical GmbH (Dental Division)

Based on long-term stability testing, it was determined that in units older than 1.5 years (17 months) the mixing rod may, in rare cases, come loose from its lock during the mixing…

Company / brand: Heraeus Medical (Dental Division) recalls

Official ID Z-1998-2026 · Official record ↗

FDA Class III · Medical device · May 6, 2026

Heraeus recall — Heraeus Medical GmbH (Dental Division)

Based on long-term stability testing, it was determined that in units older than 1.5 years (17 months) the mixing rod may, in rare cases, come loose from its lock during the mixing…

Company / brand: Heraeus Medical (Dental Division) recalls

Official ID Z-1997-2026 · Official record ↗

FDA Class II · Medical device · May 6, 2026

iLet Bionic Pancreas recall — Beta Bionics, Inc.

insulin pump software versions 1.4.2, and 1.4.3 issue with Dexcom Continuous Glucose Monitoring (CGM) G7 sensor may result in delayed CGM reading then switch to non-CGM dosing, lea…

Company / brand: Beta Bionics recalls

Official ID Z-1996-2026 · Official record ↗

FDA Class II · Medical device · May 6, 2026

Straumann n!ce Zr recall — Straumann USA LLC

Includes an incorrect screw seat interface.

Company / brand: Straumann USA recalls

Official ID Z-1995-2026 · Official record ↗

FDA Class II · Medical device · May 6, 2026

Straumann n!ce PMMA Full-arch Restoration recall — Straumann USA LLC

Includes an incorrect screw seat interface.

Company / brand: Straumann USA recalls

Official ID Z-1994-2026 · Official record ↗

FDA Class II · Medical device · May 6, 2026

Depuy Synthes recall — DEPUY (IRELAND)

The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility.

Company / brand: DEPUY (IRELAND) recalls

Official ID Z-1993-2026 · Official record ↗

FDA Class II · Medical device · May 6, 2026

Depuy Synthes recall — DEPUY (IRELAND)

The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility.

Company / brand: DEPUY (IRELAND) recalls

Official ID Z-1992-2026 · Official record ↗

FDA Class II · Medical device · May 6, 2026

Depuy Synthes recall — DEPUY (IRELAND)

The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility.

Company / brand: DEPUY (IRELAND) recalls

Official ID Z-1991-2026 · Official record ↗

FDA Class II · Medical device · May 6, 2026

Depuy Synthes recall — DEPUY (IRELAND)

The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility.

Company / brand: DEPUY (IRELAND) recalls

Official ID Z-1990-2026 · Official record ↗

FDA Class II · Medical device · May 6, 2026

Depuy Synthes recall — DEPUY (IRELAND)

The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility.

Company / brand: DEPUY (IRELAND) recalls

Official ID Z-1989-2026 · Official record ↗

FDA Class II · Medical device · May 6, 2026

Depuy Synthes recall — DEPUY (IRELAND)

The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility.

Company / brand: DEPUY (IRELAND) recalls

Official ID Z-1988-2026 · Official record ↗

FDA Class II · Medical device · May 6, 2026

Depuy Synthes recall — DEPUY (IRELAND)

The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility.

Company / brand: DEPUY (IRELAND) recalls

Official ID Z-1987-2026 · Official record ↗

FDA Class II · Medical device · May 6, 2026

Depuy Synthes recall — DEPUY (IRELAND)

The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility.

Company / brand: DEPUY (IRELAND) recalls

Official ID Z-1986-2026 · Official record ↗

FDA Class II · Medical device · May 6, 2026

Depuy Synthes recall — DEPUY (IRELAND)

The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility.

Company / brand: DEPUY (IRELAND) recalls

Official ID Z-1985-2026 · Official record ↗

FDA Class II · Medical device · May 6, 2026

Immy recall — Immuno-Mycologics, Inc

Neutralization Buffer may contain contaminants

Company / brand: Immuno-Mycologics recalls

Official ID Z-1984-2026 · Official record ↗

FDA Class II · Medical device · May 6, 2026

BD GasPak EZ Campy Pouch System recall — Becton Dickinson & Co.

BD identified an issue affecting certain lots of BD GasPak EZ CO2 and BD GasPak EZ Campy Gas Generating Pouch Systems, where gas generating sachets may produce carbon dioxide level…

Company / brand: Becton Dickinson & Co recalls

Official ID Z-1983-2026 · Official record ↗

FDA Class II · Medical device · May 6, 2026

BD GasPak EZ CO2 Pouch System recall — Becton Dickinson & Co.

BD identified an issue affecting certain lots of BD GasPak EZ CO2 and BD GasPak EZ Campy Gas Generating Pouch Systems, where gas generating sachets may produce carbon dioxide level…

Company / brand: Becton Dickinson & Co recalls

Official ID Z-1982-2026 · Official record ↗

FDA Class II · Medical device · May 6, 2026

Dimension Creatinine Flex reagent cartridge recall — Siemens Healthcare Diagnostics, Inc.

Siemens Healthcare Diagnostics is recalling certain lots of Dimension Creatinine Flex reagent cartridge (Dimension CRE2) because a potential imprecision in the Dimension CRE2 quali…

Company / brand: Siemens Healthcare Diagnostics recalls

Official ID Z-1980-2026 · Official record ↗

FDA Class II · Medical device · May 6, 2026

Philips Upgrade to MR 7700 with MR Elastography (MRE) recall — Philips North America

The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction …

Company / brand: Philips North America recalls

Official ID Z-1969-2026 · Official record ↗

FDA Class II · Medical device · May 6, 2026

Philips SmartPath to Ingenia Elition X with MR Elastography (MRE) recall — Philips North America

The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction …

Company / brand: Philips North America recalls

Official ID Z-1968-2026 · Official record ↗

FDA Class II · Medical device · May 6, 2026

Philips SmartPath to dStream for XR and 3 recall — Philips North America

The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction …

Company / brand: Philips North America recalls

Official ID Z-1967-2026 · Official record ↗

FDA Class II · Medical device · May 6, 2026

Philips SmartPath to dStream for 3 recall — Philips North America

The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction …

Company / brand: Philips North America recalls

Official ID Z-1966-2026 · Official record ↗

FDA Class II · Medical device · May 6, 2026

Philips SmartPath to dStream for 1 recall — Philips North America

The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction …

Company / brand: Philips North America recalls

Official ID Z-1965-2026 · Official record ↗

FDA Class II · Medical device · May 6, 2026

Philips MR 7700 with MR Elastography (MRE) recall — Philips North America

The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction …

Company / brand: Philips North America recalls

Official ID Z-1964-2026 · Official record ↗

FDA Class II · Medical device · May 6, 2026

Philips Ingenia Elition X with MR Elastography (MRE) recall — Philips North America

The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction …

Company / brand: Philips North America recalls

Official ID Z-1963-2026 · Official record ↗

FDA Class II · Medical device · May 6, 2026

Philips Ingenia Elition S with MR Elastography (MRE) recall — Philips North America

The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction …

Company / brand: Philips North America recalls

Official ID Z-1962-2026 · Official record ↗

FDA Class II · Medical device · May 6, 2026

Philips Ingenia Ambition X with MR Elastography (MRE) recall — Philips North America

The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction …

Company / brand: Philips North America recalls

Official ID Z-1961-2026 · Official record ↗

FDA Class II · Medical device · May 6, 2026

Philips Ingenia Ambition S with MR Elastography (MRE) recall — Philips North America

The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction …

Company / brand: Philips North America recalls

Official ID Z-1960-2026 · Official record ↗

FDA Class II · Medical device · May 6, 2026

Philips Ingenia 3 recall — Philips North America

The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction …

Company / brand: Philips North America recalls

Official ID Z-1959-2026 · Official record ↗

FDA Class II · Medical device · May 6, 2026

Philips Ingenia 3 recall — Philips North America

The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction …

Company / brand: Philips North America recalls

Official ID Z-1958-2026 · Official record ↗

FDA Class II · Medical device · May 6, 2026

Philips Ingenia 1 recall — Philips North America

The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction …

Company / brand: Philips North America recalls

Official ID Z-1957-2026 · Official record ↗

FDA Class II · Medical device · May 6, 2026

Philips Ingenia 1 recall — Philips North America

The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction …

Company / brand: Philips North America recalls

Official ID Z-1956-2026 · Official record ↗

FDA Class II · Medical device · May 6, 2026

Philips Evolution upgrade 3 recall — Philips North America

The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction …

Company / brand: Philips North America recalls

Official ID Z-1955-2026 · Official record ↗

FDA Class II · Medical device · May 6, 2026

Philips Evolution Upgrade 1 recall — Philips North America

The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction …

Company / brand: Philips North America recalls

Official ID Z-1954-2026 · Official record ↗

FDA Class II · Medical device · May 6, 2026

Philips Achieva 3 recall — Philips North America

The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction …

Company / brand: Philips North America recalls

Official ID Z-1953-2026 · Official record ↗

FDA Class II · Medical device · May 6, 2026

Philips Achieva 1 recall — Philips North America

The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction …

Company / brand: Philips North America recalls

Official ID Z-1952-2026 · Official record ↗

FDA Class II · Medical device · May 6, 2026

Philips Achieva 1 recall — Philips North America

The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction …

Company / brand: Philips North America recalls

Official ID Z-1951-2026 · Official record ↗

FDA Class II · Medical device · May 6, 2026

Brand Name recall — Advanced Bionics, LLC

The non-tamperproof battery door supplied with the sound processor fails to conform to IEC 60601-1-11:2015 by not requiring the use of a tool to replace the button/coin cell batter…

Company / brand: Advanced Bionics recalls

Official ID Z-1950-2026 · Official record ↗

FDA Class II · Medical device · May 6, 2026

Brand Name recall — Hologic, Inc

It was identified that certain devices were being operated outside the validated and FDA-cleared display configuration due to user modification of the manufacturer-installed settin…

Company / brand: Hologic recalls

Official ID Z-1949-2026 · Official record ↗

FDA Class II · Medical device · May 6, 2026

Medtronic Sphere-9 Catheter recall — Medtronic, Inc.

Ventricular fibrillation (VF) occurred during radiofrequency (RF) therapy with the Medtronic Sphere-9 catheter in patients who have a Biotronik Implantable Cardioverter Defibrillat…

Company / brand: Medtronic recalls

Official ID Z-1948-2026 · Official record ↗

FDA Class I · Medical device · May 6, 2026

AIDBAGs are first aid kits of convenience composed of individually labeled devices designe recall — North American Rescue LLC.

Kits contain the McKesson TRUE Metrix PRO Professional Monitoring Blood Glucose System that has been recalled for an issue with the software design of the E-5 Error Code where the …

Company / brand: North American Rescue recalls

Official ID Z-1947-2026 · Official record ↗

FDA Class II · Medical device · May 6, 2026

Brand Name recall — Zimmer, Inc.

Ten complaints have been received identifying issues at the time of use related to the package seal, including incomplete seals, wrinkles in the seals or peeling seals. Compromised…

Company / brand: Zimmer recalls

Official ID Z-1946-2026 · Official record ↗

FDA Class II · Medical device · May 6, 2026

Brand Name recall — Clinical Innovations, LLC

Due to complaints of device breakage at the traction force gauge to handle joint.

Company / brand: Clinical Innovations recalls

Official ID Z-1945-2026 · Official record ↗

FDA Class II · Medical device · May 6, 2026

VACUUM BAG SU LARGE recall — Milestone S.R.L.

There is a possibility of reagent leakage from the specimen container.

Company / brand: Milestone S.R.L recalls

Official ID Z-1944-2026 · Official record ↗

FDA Class II · Medical device · May 6, 2026

Mesh Style Tip Protectors CSW-03-2 recall — Healthmark Industries Co., Inc.

Product does not have FDA clearance.

Company / brand: Healthmark Industries Co recalls

Official ID Z-1943-2026 · Official record ↗

FDA Class I · Medical device · May 6, 2026

WHILL Model F recall — WHILL, INC.

Cyber vulnerability of BLE communication was found by CISA VDP program.

Company / brand: WHILL recalls

Official ID Z-1827-2026 · Official record ↗

FDA Class I · Medical device · May 6, 2026

WHILL Model C2 recall — WHILL, INC.

Cyber vulnerability of BLE communication was found by CISA VDP program.

Company / brand: WHILL recalls

Official ID Z-1826-2026 · Official record ↗

FDA Class I · Medical device · May 6, 2026

Boston Scientific Cardiac Resynchronization Therapy (CRT)labeled as recall — Boston Scientific Corporation

Updated software, Brady software maintenance release 6 (SMR6), is now available for the ACCOLADE" family of pacemakers and cardiac resynchronization therapy pacemakers (CRT-Ps)1 an…

Company / brand: Boston Scientific recalls

Official ID Z-1771-2026 · Official record ↗

FDA Class I · Medical device · May 6, 2026

Boston Scientific Pacemaker recall — Boston Scientific Corporation

Updated software, Brady software maintenance release 6 (SMR6), is now available for the ACCOLADE" family of pacemakers and cardiac resynchronization therapy pacemakers (CRT-Ps)1 an…

Company / brand: Boston Scientific recalls

Official ID Z-1770-2026 · Official record ↗

FDA Class I · Food · May 6, 2026

Black label with blue lettering recall — HEMU TRADING INC

product tested positive for Listeria Monocytogenes.

Company / brand: HEMU TRADING recalls

Official ID H-0686-2026 · Official record ↗

FDA Class II · Food · May 6, 2026

Calypso Tropic Tango Lemonade recall — King Juice Company, Inc.

Product contains undeclared Yellow No. 5.

Company / brand: King Juice Company recalls

Official ID H-0685-2026 · Official record ↗

FDA Class II · Food · May 6, 2026

My Mochi Strawberry flavored Non-Dairy Frozen Dessert recall — The Mochi Ice Cream Company, LLC

Foreign object found inside retail container.

Company / brand: The Mochi Ice Cream Company recalls

Official ID H-0684-2026 · Official record ↗

FDA Class II · Food · May 6, 2026

KLG recall — Ganesha Enterprises LLC

Undeclared food colorings (Yellow 6, Blue 1, and Yellow 5) and unapproved Acid Red 14.

Company / brand: Ganesha Enterprises recalls

Official ID H-0683-2026 · Official record ↗

FDA Class II · Food · May 6, 2026

Specially SELECTED brand Vanilla Creme Brulee recall — LACTALIS CANADA, INC

Product may contain foreign objects, specifically glass.

Company / brand: LACTALIS CANADA recalls

Official ID H-0680-2026 · Official record ↗

FDA Class II · Food · May 6, 2026

Negita Cracker- Shrimp 2 recall — Hadson (Toko) Trading Co. Inc.

Contains undeclared FD&C Yellow 6

Company / brand: Hadson (Toko) Trading Co recalls

Official ID H-0679-2026 · Official record ↗

FDA Class II · Food · May 6, 2026

52USA brand POPPING BOBA recall — Guangdong Zonegoing Food Co., LTD

Products contain unapproved colors, specifically tartrazine (FD&C Yellow 5), sunset yellow (FD&C Yellow 6), and allura red (FD&C Red 40).

Company / brand: Guangdong Zonegoing Food Co recalls

Official ID H-0678-2026 · Official record ↗

FDA Class II · Food · May 6, 2026

52USA brand POPPING BOBA recall — Guangdong Zonegoing Food Co., LTD

Products contain unapproved colors, specifically tartrazine (FD&C Yellow 5), sunset yellow (FD&C Yellow 6), and allura red (FD&C Red 40).

Company / brand: Guangdong Zonegoing Food Co recalls

Official ID H-0677-2026 · Official record ↗

FDA Class II · Food · May 6, 2026

52USA brand POPPING BOBA recall — Guangdong Zonegoing Food Co., LTD

Products contain unapproved colors, specifically tartrazine (FD&C Yellow 5), sunset yellow (FD&C Yellow 6), and allura red (FD&C Red 40).

Company / brand: Guangdong Zonegoing Food Co recalls

Official ID H-0676-2026 · Official record ↗

FDA Class II · Food · May 6, 2026

Top Lid Label recall — Schreiber Foods Inc

Undeclared allergen (almond).

Company / brand: Schreiber Foods recalls

Official ID H-0675-2026 · Official record ↗

FDA Class II · Drug · May 6, 2026

Alendronate Sodium Oral Solution recall — Hikma Pharmaceuticals USA INC

This recall is being conducted due to out of specification assay results in a limited number of bottles that were stored on side.

Company / brand: Hikma Pharmaceuticals USA recalls

Official ID D-0526-2026 · Official record ↗

FDA Class III · Drug · May 6, 2026

Lidocaine Wound Gel (Benzalkonium Chloride recall — Water-Jel Technologies, LLC

Failed PH Specifications

Company / brand: Water-Jel Technologies recalls

Official ID D-0509-2026 · Official record ↗

FDA Class II · Drug · May 6, 2026

fentaNYL Citrate Injectable Solution in 0 recall — Wells Pharma of Houston LLC

cGMP deviations.

Company / brand: Wells Pharma of Houston recalls

Official ID D-0508-2026 · Official record ↗

FDA Class II · Drug · May 6, 2026

Ketamine Hydrochloride Injectable Solution recall — Wells Pharma of Houston LLC

cGMP deviations.

Company / brand: Wells Pharma of Houston recalls

Official ID D-0507-2026 · Official record ↗

FDA Class II · Drug · May 6, 2026

fentaNYL Citrate Injectable Solution in 0 recall — Wells Pharma of Houston LLC

cGMP deviations.

Company / brand: Wells Pharma of Houston recalls

Official ID D-0506-2026 · Official record ↗

FDA Class II · Drug · May 6, 2026

fentaNYL Citrate Injectable Solution recall — Wells Pharma of Houston LLC

cGMP deviations.

Company / brand: Wells Pharma of Houston recalls

Official ID D-0505-2026 · Official record ↗

FDA Class II · Drug · May 6, 2026

fentaNYL Citrate injectable Solution in 0 recall — Wells Pharma of Houston LLC

cGMP deviations.

Company / brand: Wells Pharma of Houston recalls

Official ID D-0504-2026 · Official record ↗

FDA Class II · Drug · May 6, 2026

fentaNYL Citrate Injectable Solution recall — Wells Pharma of Houston LLC

cGMP deviations.

Company / brand: Wells Pharma of Houston recalls

Official ID D-0503-2026 · Official record ↗

FDA Class II · Drug · May 6, 2026

Phenylephrine Hydrochloride Injectable Solution recall — Wells Pharma of Houston LLC

cGMP deviations.

Company / brand: Wells Pharma of Houston recalls

Official ID D-0502-2026 · Official record ↗

FDA Class II · Drug · May 6, 2026

Similasan recall — Thea Pharma, Inc.

Lack of Assurance of Sterility: This recall has been initiated due to CGMP deviations found by the FDA during an inspection of the manufacturer.

Company / brand: Thea Pharma recalls

Official ID D-0501-2026 · Official record ↗

FDA Class II · Drug · May 6, 2026

iVIZIA recall — Thea Pharma, Inc.

Lack of Assurance of Sterility: This recall has been initiated due to CGMP deviations found by the FDA during an inspection of the manufacturer.

Company / brand: Thea Pharma recalls

Official ID D-0500-2026 · Official record ↗

FDA Class II · Drug · May 6, 2026

Optase Dry Eye Intense Drops (Glycerin 0 recall — SCOPE HEALTH

Lack of Assurance of Sterility

Company / brand: SCOPE HEALTH recalls

Official ID D-0499-2026 · Official record ↗

FDA Class III · Drug · May 6, 2026

Levocarnitine Injection recall — American Regent, Inc.

Labeling: Missing Label

Company / brand: American Regent recalls

Official ID D-0494-2026 · Official record ↗

FDA Class II · Drug · May 6, 2026

GenTeal Tears recall — Alcon Research LLC

Lack of Assurance of Sterility: Due to FDA inspection observations that it believes may impact product quality.

Company / brand: Alcon Research recalls

Official ID D-0492-2026 · Official record ↗

FDA Class II · Drug · May 6, 2026

Systane recall — Alcon Research LLC

Lack of Assurance of Sterility: Due to FDA inspection observations that it believes may impact product quality.

Company / brand: Alcon Research recalls

Official ID D-0491-2026 · Official record ↗

FDA Class II · Medical device · April 29, 2026

Diversatek Healthcare Viper¿ 3-Stage Wire Guided Balloon Dilator recall — Diversatek Healthcare

The catheter inflation tag attached to the device may contain an incorrect part number with incorrect balloon diameter sizes and inflation pressures for each stage.

Company / brand: Diversatek Healthcare recalls

Official ID Z-1941-2026 · Official record ↗

FDA Class II · Medical device · April 29, 2026

Diversatek Healthcare Viper¿ 3-Stage Wire Guided Balloon Dilator recall — Diversatek Healthcare

The catheter inflation tag attached to the device may contain an incorrect part number with incorrect balloon diameter sizes and inflation pressures for each stage.

Company / brand: Diversatek Healthcare recalls

Official ID Z-1940-2026 · Official record ↗

FDA Class II · Medical device · April 29, 2026

Diversatek Healthcare Viper¿ 3-Stage Wire Guided Balloon Dilator recall — Diversatek Healthcare

The catheter inflation tag attached to the device may contain an incorrect part number with incorrect balloon diameter sizes and inflation pressures for each stage.

Company / brand: Diversatek Healthcare recalls

Official ID Z-1939-2026 · Official record ↗

FDA Class II · Medical device · April 29, 2026

Diversatek Healthcare Viper¿ 3-Stage Fixed Wire Balloon Dilator recall — Diversatek Healthcare

The catheter inflation tag attached to the device may contain an incorrect part number with incorrect balloon diameter sizes and inflation pressures for each stage.

Company / brand: Diversatek Healthcare recalls

Official ID Z-1938-2026 · Official record ↗

FDA Class II · Medical device · April 29, 2026

Protocol Configuration Tool (PCT) software v1 recall — Foundation Medicine, Inc.

Potential for spontaneous closures of Hamilton HxRunControl software during execution of Autolys protocols after deployment of the PCT software for AutoLys Hamilton STAR.

Company / brand: Foundation Medicine recalls

Official ID Z-1937-2026 · Official record ↗

FDA Class II · Medical device · April 29, 2026

LSL Healthcare Wound Closure Tray recall — LSL Healthcare Inc.

Medical procedure kits were distributed containing Webcol Large Alcohol Prep Pads which were subsequently recalled for non-sterility.

Company / brand: LSL Healthcare recalls

Official ID Z-1933-2026 · Official record ↗

FDA Class II · Medical device · April 29, 2026

LSL Healthcare recall — LSL Healthcare Inc.

Medical procedure kits were distributed containing Webcol Large Alcohol Prep Pads which were subsequently recalled for non-sterility.

Company / brand: LSL Healthcare recalls

Official ID Z-1932-2026 · Official record ↗

FDA Class II · Medical device · April 29, 2026

LSL Healthcare recall — LSL Healthcare Inc.

Medical procedure kits were distributed containing Webcol Large Alcohol Prep Pads which were subsequently recalled for non-sterility.

Company / brand: LSL Healthcare recalls

Official ID Z-1931-2026 · Official record ↗

FDA Class II · Medical device · April 29, 2026

LSL Healthcare recall — LSL Healthcare Inc.

Medical procedure kits were distributed containing Webcol Large Alcohol Prep Pads which were subsequently recalled for non-sterility.

Company / brand: LSL Healthcare recalls

Official ID Z-1930-2026 · Official record ↗

FDA Class II · Medical device · April 29, 2026

LSL Healthcare recall — LSL Healthcare Inc.

Medical procedure kits were distributed containing Webcol Large Alcohol Prep Pads which were subsequently recalled for non-sterility.

Company / brand: LSL Healthcare recalls

Official ID Z-1929-2026 · Official record ↗

FDA Class II · Medical device · April 29, 2026

LSL Healthcare recall — LSL Healthcare Inc.

Medical procedure kits were distributed containing Webcol Large Alcohol Prep Pads which were subsequently recalled for non-sterility.

Company / brand: LSL Healthcare recalls

Official ID Z-1928-2026 · Official record ↗

FDA Class II · Medical device · April 29, 2026

Sequencing Agent SEQ0067 recall — Foundation Medicine, Inc.

Possible increase in phasing, potentially resulting in false-positive BARD1 splice site indel artifact variants

Company / brand: Foundation Medicine recalls

Official ID Z-1927-2026 · Official record ↗

FDA Class II · Medical device · April 29, 2026

Flamingo Funnel Large recall — SurgiSmoke Solutions

Certain lots of product were associated with a manufacturing nonconformance involving use of a non-gamma sterilization compatible drape.

Company / brand: SurgiSmoke Solutions recalls

Official ID Z-1926-2026 · Official record ↗

FDA Class II · Medical device · April 29, 2026

Flamingo Funnel Medium recall — SurgiSmoke Solutions

Certain lots of product were associated with a manufacturing nonconformance involving use of a non-gamma sterilization compatible drape.

Company / brand: SurgiSmoke Solutions recalls

Official ID Z-1925-2026 · Official record ↗

FDA Class II · Medical device · April 29, 2026

Flamingo Funnel Small recall — SurgiSmoke Solutions

Certain lots of product were associated with a manufacturing nonconformance involving use of a non-gamma sterilization compatible drape.

Company / brand: SurgiSmoke Solutions recalls

Official ID Z-1924-2026 · Official record ↗

FDA Class II · Medical device · April 29, 2026

Oxoid Agglutinating Sera recall — Remel Europe Ltd.

Affected lots are not performing to IFU criteria showing cross reactions with 2-0 within 60 seconds. Cross-reactivity may result in the misidentification of a Salmonella 9-O seroty…

Company / brand: Remel Europe recalls

Official ID Z-1923-2026 · Official record ↗

FDA Class II · Medical device · April 29, 2026

Access Total T4 Calibrator recall — Beckman Coulter, Inc.

Beckman Coulter has identified that Access Total T4 Calibrator lots (PN 33805) exhibit a negative bias on DxI 600/800 instruments, with slopes outside product specifications. A fal…

Company / brand: Beckman Coulter recalls

Official ID Z-1922-2026 · Official record ↗

FDA Class II · Medical device · April 29, 2026

Custom Convenience Kits Pre Op Kit - NS recall — Windstone Medical Packaging, Inc.

The product correction was initiated because B Braun is issuing a voluntary Urgent Medical Device Correction for gravity IV administration sets as well as pump administration sets …

Company / brand: Windstone Medical Packaging recalls

Official ID Z-1921-2026 · Official record ↗

FDA Class II · Medical device · April 29, 2026

Custom Convenience Kits Pre Op Kit - NS recall — Windstone Medical Packaging, Inc.

The product correction was initiated because B Braun is issuing a voluntary Urgent Medical Device Correction for gravity IV administration sets as well as pump administration sets …

Company / brand: Windstone Medical Packaging recalls

Official ID Z-1920-2026 · Official record ↗

FDA Class II · Medical device · April 29, 2026

Custom Convenience Kits Pre Op Kit - NS recall — Windstone Medical Packaging, Inc.

The product correction was initiated because B Braun is issuing a voluntary Urgent Medical Device Correction for gravity IV administration sets as well as pump administration sets …

Company / brand: Windstone Medical Packaging recalls

Official ID Z-1919-2026 · Official record ↗

FDA Class II · Medical device · April 29, 2026

Rover Mobile X-ray System Model/Catalog Number recall — Micro-X Ltd.

X-Ray generator may malfunction resulting in the X-Ray being inoperable.

Company / brand: Micro-X recalls

Official ID Z-1918-2026 · Official record ↗

FDA Class II · Medical device · April 29, 2026

Arrowg+ard Blue¿ MAC" Two-Lumen Central Venous Access Kit for use with 7 recall — ARROW INTERNATIONAL, LLC

Due to receiving a notice from a supplier that the liquid adhesive was incorrectly manufactured

Company / brand: ARROW INTERNATIONAL recalls

Official ID Z-1917-2026 · Official record ↗

FDA Class II · Medical device · April 29, 2026

MAC" Two-Lumen Central Venous Access Kit for use with 7 recall — ARROW INTERNATIONAL, LLC

Due to receiving a notice from a supplier that the liquid adhesive was incorrectly manufactured

Company / brand: ARROW INTERNATIONAL recalls

Official ID Z-1916-2026 · Official record ↗

FDA Class II · Medical device · April 29, 2026

Pressure Injectable Arrowg+ard Blue Plus¿ Four-Lumen CVC Kit REF ASK-45854-PUPM1 UDI code recall — ARROW INTERNATIONAL, LLC

Due to receiving a notice from a supplier that the liquid adhesive was incorrectly manufactured

Company / brand: ARROW INTERNATIONAL recalls

Official ID Z-1915-2026 · Official record ↗

FDA Class II · Medical device · April 29, 2026

ARROW recall — ARROW INTERNATIONAL, LLC

Due to receiving a notice from a supplier that the liquid adhesive was incorrectly manufactured

Company / brand: ARROW INTERNATIONAL recalls

Official ID Z-1914-2026 · Official record ↗

FDA Class II · Medical device · April 29, 2026

FLEXTIP PLUS EPIDURAL CATHETER recall — ARROW INTERNATIONAL, LLC

Due to receiving a notice from a supplier that the liquid adhesive was incorrectly manufactured

Company / brand: ARROW INTERNATIONAL recalls

Official ID Z-1913-2026 · Official record ↗

FDA Class II · Medical device · April 29, 2026

PERCUTANEOUS SHEATH INTRODUCER with 7 recall — ARROW INTERNATIONAL, LLC

Due to receiving a notice from a supplier that the liquid adhesive was incorrectly manufactured

Company / brand: ARROW INTERNATIONAL recalls

Official ID Z-1912-2026 · Official record ↗

FDA Class II · Medical device · April 29, 2026

ARROW RADIAL ARTERY CATHETERIZATION KIT REF ASK-04220-UCL1 UDI code recall — ARROW INTERNATIONAL, LLC

Due to receiving a notice from a supplier that the liquid adhesive was incorrectly manufactured

Company / brand: ARROW INTERNATIONAL recalls

Official ID Z-1911-2026 · Official record ↗

FDA Class II · Medical device · April 29, 2026

Arrow Echogenic Introducer Needle REF ASK-04001-BWK2 UDI code recall — ARROW INTERNATIONAL, LLC

Due to receiving a notice from a supplier that the liquid adhesive were incorrectly manufactured

Company / brand: ARROW INTERNATIONAL recalls

Official ID Z-1910-2026 · Official record ↗

FDA Class II · Medical device · April 29, 2026

OER-ELITE Endoscope Reprocessor Connecting Tubes recall — Olympus Corporation of the Americas

Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.

Company / brand: Olympus of the Americas recalls

Official ID Z-1909-2026 · Official record ↗

FDA Class II · Medical device · April 29, 2026

OER-ELITE Endoscope Reprocessor Connecting Tubes recall — Olympus Corporation of the Americas

Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.

Company / brand: Olympus of the Americas recalls

Official ID Z-1908-2026 · Official record ↗

FDA Class II · Medical device · April 29, 2026

OER-ELITE Endoscope Reprocessor Connecting Tubes recall — Olympus Corporation of the Americas

Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.

Company / brand: Olympus of the Americas recalls

Official ID Z-1907-2026 · Official record ↗

FDA Class II · Medical device · April 29, 2026

OER-ELITE Endoscope Reprocessor Connecting Tubes recall — Olympus Corporation of the Americas

Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.

Company / brand: Olympus of the Americas recalls

Official ID Z-1906-2026 · Official record ↗

FDA Class II · Medical device · April 29, 2026

OER-ELITE Endoscope Reprocessor Connecting Tubes recall — Olympus Corporation of the Americas

Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.

Company / brand: Olympus of the Americas recalls

Official ID Z-1905-2026 · Official record ↗

FDA Class II · Medical device · April 29, 2026

OER-ELITE Endoscope Reprocessor Connecting Tubes recall — Olympus Corporation of the Americas

Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.

Company / brand: Olympus of the Americas recalls

Official ID Z-1904-2026 · Official record ↗

FDA Class II · Medical device · April 29, 2026

OER-ELITE Endoscope Reprocessor Connecting Tubes recall — Olympus Corporation of the Americas

XXX

Company / brand: Olympus of the Americas recalls

Official ID Z-1903-2026 · Official record ↗

FDA Class II · Medical device · April 29, 2026

OER-ELITE Endoscope Reprocessor Connecting Tubes recall — Olympus Corporation of the Americas

Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.

Company / brand: Olympus of the Americas recalls

Official ID Z-1902-2026 · Official record ↗

FDA Class II · Medical device · April 29, 2026

OER-ELITE Endoscope Reprocessor Connecting Tubes recall — Olympus Corporation of the Americas

Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.

Company / brand: Olympus of the Americas recalls

Official ID Z-1901-2026 · Official record ↗

FDA Class II · Medical device · April 29, 2026

OER-ELITE Endoscope Reprocessor Connecting Tubes recall — Olympus Corporation of the Americas

Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.

Company / brand: Olympus of the Americas recalls

Official ID Z-1900-2026 · Official record ↗

FDA Class II · Medical device · April 29, 2026

OER-ELITE Endoscope Reprocessor Connecting Tubes recall — Olympus Corporation of the Americas

Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.

Company / brand: Olympus of the Americas recalls

Official ID Z-1899-2026 · Official record ↗

FDA Class II · Medical device · April 29, 2026

OER-ELITE Endoscope Reprocessor Connecting Tubes recall — Olympus Corporation of the Americas

Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.

Company / brand: Olympus of the Americas recalls

Official ID Z-1898-2026 · Official record ↗

FDA Class II · Medical device · April 29, 2026

nanOss 3D Advanced Bone Graft Substitute nanOss 3D Plus Advanced Bone Graft Substitute 90- recall — XTANT Medical Holdings, Inc

Products were incorrectly labeled with a 5-year shelf life. The approved and validated shelf life is four years.

Company / brand: XTANT Medical Holdings recalls

Official ID Z-1897-2026 · Official record ↗

FDA Class II · Medical device · April 29, 2026

Avitene Ultrafoam Microfibrillar Collagen Hemostat - 8cm x 6 recall — Davol, Inc.

Potential for product to contain foreign matter, confirmed to be inspect fragments.

Company / brand: Davol recalls

Official ID Z-1896-2026 · Official record ↗

FDA Class II · Medical device · April 29, 2026

LeadCare Ultra Blood Lead Test Kit recall — Magellan Diagnostics, Inc.

Customers reported observing unexpectedly elevated results when using certain third-party micro-collection devices to collect capillary samples for testing with the LeadCare Test S…

Company / brand: Magellan Diagnostics recalls

Official ID Z-1895-2026 · Official record ↗

FDA Class II · Medical device · April 29, 2026

LeadCare¿ Plus Blood Lead Test Kit recall — Magellan Diagnostics, Inc.

Customers reported observing unexpectedly elevated results when using certain third-party micro-collection devices to collect capillary samples for testing with the LeadCare Test S…

Company / brand: Magellan Diagnostics recalls

Official ID Z-1894-2026 · Official record ↗

FDA Class II · Medical device · April 29, 2026

(1)(2) LeadCare¿ II Blood Lead Test Kit recall — Magellan Diagnostics, Inc.

Customers reported observing unexpectedly elevated results when using certain third-party micro-collection devices to collect capillary samples for testing with the LeadCare Test S…

Company / brand: Magellan Diagnostics recalls

Official ID Z-1893-2026 · Official record ↗

FDA Class II · Medical device · April 29, 2026

Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes ENS recall — Medline Industries, LP

Unapproved design changes to the products outside of the 510(k) clearance.

Company / brand: Medline Industries recalls

Official ID Z-1892-2026 · Official record ↗

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FDA last checked October 22, 2026 at 12:00 PM UTC.