Fresh Recalls

Medical device recalls — page 8

1,617 recent medical device recalls in our current data. Showing 1,401–1,600, newest first.

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

Affected product: Halyard CATH LAB kit recall status

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

Affected product: Halyard CATH LAB kit recall status

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

Affected product: Halyard CARDIAC CATH TRAY SHANDS JAX kit recall status

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

Affected product: Halyard CARDIAC CATH PACK SAN23CARDQ kit recall status

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

Affected product: Halyard CARDIAC CATH PACK kit recall status

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

Affected product: VOCSN V+Pro package recall status

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

Affected product: Beacon Tip Centimeter Sizing Catheter RPN/GPN NR5 recall status

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

Affected product: Aurous Centimeter Sizing Catheter RPN N5 recall status

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

Affected product: Centimeter Sizing Catheter RPN N5 recall status

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

Affected product: Intuitive 8 mm SureForm 30 Gray Reloads Reference Numbers recall status

Official ID Z-1855-2026 · 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

Affected product: Medline and Centurion medical convenience kits recall status

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

Affected product: Centurion medical convenience kits recall status

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

Affected product: Medline or Centurion medical convenience kits recall status

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

Affected product: Centurion medical convenience kits recall status

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

Affected product: Medline and Centurion medical convenience kits recall status

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

Affected product: Medline medical convenience kits recall status

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

Affected product: Centurion medical convenience kits recall status

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

Affected product: Medline medical procedure kits recall status

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

Affected product: Medline medical procedure kits recall status

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

Affected product: Medline medical procedure kits recall status

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

Affected product: Medline medical procedure kits recall status

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

Affected product: Medline medical procedure kits recall status

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

Affected product: Medline medical procedure kits recall status

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

Affected product: Medline medical procedure kits recall status

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

Affected product: Medline medical procedure kits recall status

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

Affected product: Medline medical procedure kits recall status

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

Affected product: Medline medical procedure kits recall status

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

Affected product: Centurion medical procedure kits recall status

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

Affected product: Medline medical procedure kits recall status

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

Affected product: Medline medical procedure kits recall status

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

Affected product: Medline medical procedure kits recall status

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

Affected product: Medline medical procedure kits recall status

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

Affected product: Medline medical procedure kits recall status

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

Affected product: Medline medical procedure kits recall status

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

Affected product: Medline and Centurion medical procedure kits recall status

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

Affected product: Medline medical procedure kits recall status

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

Affected product: Medline medical procedure kits recall status

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

Affected product: Medline medical procedure kits recall status

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

Affected product: Medline medical procedure kits recall status

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

Affected product: Medline medical procedure kits recall status

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

Affected product: Medline medical procedure kits recall status

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

Affected product: Medline medical procedure kits recall status

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

Affected product: Medline medical procedure kits recall status

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

Affected product: Medline medical procedure kits recall status

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

Affected product: Medline medical procedure kits recall status

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

Affected product: Medline medical procedure kits recall status

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

Affected product: Medline medical procedure kits recall status

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

Affected product: Medline Neuro Sponges recall status

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

Affected product: Brand Name recall status

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

Affected product: epoc BGEM BUN Test Card (25 pk) for the epoc Blood Analysis System recall status

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

Affected product: Philips Bridge Prep Kit REF recall status

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

Affected product: Philips Bridge Prep Kit REF recall status

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

Affected product: Philips Bridge Prep Kit REF recall status

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

Affected product: i-STAT G3+ cartridge recall status

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

Affected product: i-STAT EG6+ cartridge recall status

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

Affected product: i-STAT EG7+ cartridge recall status

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

Affected product: Heraeus recall status

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

Affected product: Heraeus recall status

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

Affected product: iLet Bionic Pancreas recall status

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

Affected product: Straumann n!ce Zr recall status

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

Affected product: Straumann n!ce PMMA Full-arch Restoration recall status

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

Affected product: Depuy Synthes recall status

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

Affected product: Depuy Synthes recall status

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

Affected product: Depuy Synthes recall status

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

Affected product: Depuy Synthes recall status

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

Affected product: Depuy Synthes recall status

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

Affected product: Depuy Synthes recall status

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

Affected product: Depuy Synthes recall status

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

Affected product: Depuy Synthes recall status

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

Affected product: Depuy Synthes recall status

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

Affected product: Immy recall status

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

Affected product: BD GasPak EZ Campy Pouch System recall status

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

Affected product: BD GasPak EZ CO2 Pouch System recall status

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

Affected product: Dimension Creatinine Flex reagent cartridge recall status

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

Affected product: Philips Upgrade to MR 7700 with MR Elastography (MRE) recall status

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

Affected product: Philips SmartPath to Ingenia Elition X with MR Elastography (MRE) recall status

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

Affected product: Philips SmartPath to dStream for XR and 3 recall status

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

Affected product: Philips SmartPath to dStream for 3 recall status

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

Affected product: Philips SmartPath to dStream for 1 recall status

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

Affected product: Philips MR 7700 with MR Elastography (MRE) recall status

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

Affected product: Philips Ingenia Elition X with MR Elastography (MRE) recall status

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

Affected product: Philips Ingenia Elition S with MR Elastography (MRE) recall status

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

Affected product: Philips Ingenia Ambition X with MR Elastography (MRE) recall status

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

Affected product: Philips Ingenia Ambition S with MR Elastography (MRE) recall status

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

Affected product: Philips Ingenia 3 recall status

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

Affected product: Philips Ingenia 3 recall status

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

Affected product: Philips Ingenia 1 recall status

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

Affected product: Philips Ingenia 1 recall status

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

Affected product: Philips Evolution upgrade 3 recall status

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

Affected product: Philips Evolution Upgrade 1 recall status

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

Affected product: Philips Achieva 3 recall status

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

Affected product: Philips Achieva 1 recall status

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

Affected product: Philips Achieva 1 recall status

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

Affected product: Brand Name recall status

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

Affected product: Brand Name recall status

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

Affected product: Medtronic Sphere-9 Catheter recall status

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

Affected product: AIDBAGs are first aid kits of convenience composed of individually labeled devices designe recall status

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

Affected product: Brand Name recall status

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

Affected product: Brand Name recall status

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

Affected product: VACUUM BAG SU LARGE recall status

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

Affected product: Mesh Style Tip Protectors CSW-03-2 recall status

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

Affected product: WHILL Model F recall status

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

Affected product: WHILL Model C2 recall status

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

Affected product: Boston Scientific Cardiac Resynchronization Therapy (CRT)labeled as recall status

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

Affected product: Boston Scientific Pacemaker recall status

Official ID Z-1770-2026 · 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

Affected product: Diversatek Healthcare Viper¿ 3-Stage Wire Guided Balloon Dilator recall status

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

Affected product: Diversatek Healthcare Viper¿ 3-Stage Wire Guided Balloon Dilator recall status

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

Affected product: Diversatek Healthcare Viper¿ 3-Stage Wire Guided Balloon Dilator recall status

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

Affected product: Diversatek Healthcare Viper¿ 3-Stage Fixed Wire Balloon Dilator recall status

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

Affected product: Protocol Configuration Tool (PCT) software v1 recall status

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

Affected product: LSL Healthcare Wound Closure Tray recall status

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

Affected product: LSL Healthcare recall status

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

Affected product: LSL Healthcare recall status

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

Affected product: LSL Healthcare recall status

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

Affected product: LSL Healthcare recall status

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

Affected product: LSL Healthcare recall status

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

Affected product: Sequencing Agent SEQ0067 recall status

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

Affected product: Flamingo Funnel Large recall status

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

Affected product: Flamingo Funnel Medium recall status

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

Affected product: Flamingo Funnel Small recall status

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

Affected product: Oxoid Agglutinating Sera recall status

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

Affected product: Access Total T4 Calibrator recall status

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

Affected product: Custom Convenience Kits Pre Op Kit - NS recall status

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

Affected product: Custom Convenience Kits Pre Op Kit - NS recall status

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

Affected product: Custom Convenience Kits Pre Op Kit - NS recall status

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

Affected product: Rover Mobile X-ray System Model/Catalog Number recall status

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

Affected product: Arrowg+ard Blue¿ MAC" Two-Lumen Central Venous Access Kit for use with 7 recall status

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

Affected product: MAC" Two-Lumen Central Venous Access Kit for use with 7 recall status

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

Affected product: Pressure Injectable Arrowg+ard Blue Plus¿ Four-Lumen CVC Kit REF ASK-45854-PUPM1 UDI code recall status

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

Affected product: ARROW recall status

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

Affected product: FLEXTIP PLUS EPIDURAL CATHETER recall status

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

Affected product: PERCUTANEOUS SHEATH INTRODUCER with 7 recall status

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

Affected product: ARROW RADIAL ARTERY CATHETERIZATION KIT REF ASK-04220-UCL1 UDI code recall status

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

Affected product: Arrow Echogenic Introducer Needle REF ASK-04001-BWK2 UDI code recall status

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

Affected product: OER-ELITE Endoscope Reprocessor Connecting Tubes recall status

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

Affected product: OER-ELITE Endoscope Reprocessor Connecting Tubes recall status

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

Affected product: OER-ELITE Endoscope Reprocessor Connecting Tubes recall status

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

Affected product: OER-ELITE Endoscope Reprocessor Connecting Tubes recall status

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

Affected product: OER-ELITE Endoscope Reprocessor Connecting Tubes recall status

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

Affected product: OER-ELITE Endoscope Reprocessor Connecting Tubes recall status

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

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Company / brand: Olympus of the Americas recalls

Affected product: OER-ELITE Endoscope Reprocessor Connecting Tubes recall status

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

Affected product: OER-ELITE Endoscope Reprocessor Connecting Tubes recall status

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

Affected product: OER-ELITE Endoscope Reprocessor Connecting Tubes recall status

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

Affected product: OER-ELITE Endoscope Reprocessor Connecting Tubes recall status

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

Affected product: OER-ELITE Endoscope Reprocessor Connecting Tubes recall status

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

Affected product: OER-ELITE Endoscope Reprocessor Connecting Tubes recall status

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

Affected product: nanOss 3D Advanced Bone Graft Substitute nanOss 3D Plus Advanced Bone Graft Substitute 90- recall status

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

Affected product: Avitene Ultrafoam Microfibrillar Collagen Hemostat - 8cm x 6 recall status

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

Affected product: LeadCare Ultra Blood Lead Test Kit recall status

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

Affected product: LeadCare¿ Plus Blood Lead Test Kit recall status

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

Affected product: (1)(2) LeadCare¿ II Blood Lead Test Kit recall status

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

Affected product: Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes ENS recall status

Official ID Z-1892-2026 · Official record ↗

FDA Class II · Medical device · April 29, 2026

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

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

Company / brand: Medline Industries recalls

Affected product: Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes ART recall status

Official ID Z-1891-2026 · Official record ↗

FDA Class II · Medical device · April 29, 2026

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

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

Company / brand: Medline Industries recalls

Affected product: Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes ADD recall status

Official ID Z-1890-2026 · Official record ↗

FDA Class II · Medical device · April 29, 2026

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

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

Company / brand: Medline Industries recalls

Affected product: Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes E P recall status

Official ID Z-1889-2026 · Official record ↗

FDA Class II · Medical device · April 29, 2026

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

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

Company / brand: Medline Industries recalls

Affected product: Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes ART recall status

Official ID Z-1888-2026 · Official record ↗

FDA Class II · Medical device · April 29, 2026

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

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

Company / brand: Medline Industries recalls

Affected product: Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes EXT recall status

Official ID Z-1887-2026 · Official record ↗

FDA Class II · Medical device · April 29, 2026

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

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

Company / brand: Medline Industries recalls

Affected product: Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes EYE recall status

Official ID Z-1886-2026 · Official record ↗

FDA Class II · Medical device · April 29, 2026

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

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

Company / brand: Medline Industries recalls

Affected product: Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes GU recall status

Official ID Z-1885-2026 · Official record ↗

FDA Class II · Medical device · April 29, 2026

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

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

Company / brand: Medline Industries recalls

Affected product: Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes ANG recall status

Official ID Z-1884-2026 · Official record ↗

FDA Class II · Medical device · April 29, 2026

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

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

Company / brand: Medline Industries recalls

Affected product: Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes Med recall status

Official ID Z-1883-2026 · Official record ↗

FDA Class II · Medical device · April 29, 2026

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

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

Company / brand: Medline Industries recalls

Affected product: Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes FAC recall status

Official ID Z-1882-2026 · Official record ↗

FDA Class II · Medical device · April 29, 2026

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

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

Company / brand: Medline Industries recalls

Affected product: Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes BAR recall status

Official ID Z-1881-2026 · Official record ↗

FDA Class II · Medical device · April 29, 2026

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

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

Company / brand: Medline Industries recalls

Affected product: Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes MIN recall status

Official ID Z-1880-2026 · Official record ↗

FDA Class II · Medical device · April 29, 2026

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

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

Company / brand: Medline Industries recalls

Affected product: Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes BIO recall status

Official ID Z-1879-2026 · Official record ↗

FDA Class II · Medical device · April 29, 2026

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

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

Company / brand: Medline Industries recalls

Affected product: Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes TAV recall status

Official ID Z-1878-2026 · Official record ↗

FDA Class II · Medical device · April 29, 2026

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

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

Company / brand: Medline Industries recalls

Affected product: Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes ADU recall status

Official ID Z-1877-2026 · Official record ↗

FDA Class II · Medical device · April 29, 2026

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

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

Company / brand: Medline Industries recalls

Affected product: Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes JUD recall status

Official ID Z-1876-2026 · Official record ↗

FDA Class II · Medical device · April 29, 2026

AccuVu Angiographic Catheter recall — Angiodynamics, Inc.

The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.

Company / brand: Angiodynamics recalls

Affected product: AccuVu Angiographic Catheter recall status

Official ID Z-1875-2026 · Official record ↗

FDA Class II · Medical device · April 29, 2026

AccuVu Angiographic Catheter recall — Angiodynamics, Inc.

The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.

Company / brand: Angiodynamics recalls

Affected product: AccuVu Angiographic Catheter recall status

Official ID Z-1874-2026 · Official record ↗

FDA Class II · Medical device · April 29, 2026

AccuVu Angiographic Catheter recall — Angiodynamics, Inc.

The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.

Company / brand: Angiodynamics recalls

Affected product: AccuVu Angiographic Catheter recall status

Official ID Z-1873-2026 · Official record ↗

FDA Class II · Medical device · April 29, 2026

AccuVu Angiographic Catheter recall — Angiodynamics, Inc.

The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.

Company / brand: Angiodynamics recalls

Affected product: AccuVu Angiographic Catheter recall status

Official ID Z-1872-2026 · Official record ↗

FDA Class II · Medical device · April 29, 2026

Soft-Vu Angiographic Catheter recall — Angiodynamics, Inc.

The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.

Company / brand: Angiodynamics recalls

Affected product: Soft-Vu Angiographic Catheter recall status

Official ID Z-1871-2026 · Official record ↗

FDA Class II · Medical device · April 29, 2026

Soft-Vu Angiographic Catheter recall — Angiodynamics, Inc.

The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.

Company / brand: Angiodynamics recalls

Affected product: Soft-Vu Angiographic Catheter recall status

Official ID Z-1870-2026 · Official record ↗

FDA Class II · Medical device · April 29, 2026

Soft-Vu Angiographic Catheter recall — Angiodynamics, Inc.

The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.

Company / brand: Angiodynamics recalls

Affected product: Soft-Vu Angiographic Catheter recall status

Official ID Z-1869-2026 · Official record ↗

FDA Class II · Medical device · April 29, 2026

Soft-Vu Angiographic Catheter recall — Angiodynamics, Inc.

The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.

Company / brand: Angiodynamics recalls

Affected product: Soft-Vu Angiographic Catheter recall status

Official ID Z-1868-2026 · Official record ↗

FDA Class II · Medical device · April 29, 2026

Soft-Vu Angiographic Catheter recall — Angiodynamics, Inc.

The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.

Company / brand: Angiodynamics recalls

Affected product: Soft-Vu Angiographic Catheter recall status

Official ID Z-1867-2026 · Official record ↗

FDA Class II · Medical device · April 29, 2026

Soft-Vu Angiographic Catheter recall — Angiodynamics, Inc.

The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.

Company / brand: Angiodynamics recalls

Affected product: Soft-Vu Angiographic Catheter recall status

Official ID Z-1866-2026 · Official record ↗

FDA Class II · Medical device · April 29, 2026

Soft-Vu Angiographic Catheter recall — Angiodynamics, Inc.

The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.

Company / brand: Angiodynamics recalls

Affected product: Soft-Vu Angiographic Catheter recall status

Official ID Z-1865-2026 · Official record ↗

FDA Class II · Medical device · April 29, 2026

Soft-Vu Angiographic Catheter recall — Angiodynamics, Inc.

The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.

Company / brand: Angiodynamics recalls

Affected product: Soft-Vu Angiographic Catheter recall status

Official ID Z-1864-2026 · Official record ↗

FDA Class II · Medical device · April 29, 2026

Soft-Vu Angiographic Catheter recall — Angiodynamics, Inc.

The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.

Company / brand: Angiodynamics recalls

Affected product: Soft-Vu Angiographic Catheter recall status

Official ID Z-1863-2026 · Official record ↗

FDA Class II · Medical device · April 29, 2026

Soft-Vu Angiographic Catheter recall — Angiodynamics, Inc.

The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.

Company / brand: Angiodynamics recalls

Affected product: Soft-Vu Angiographic Catheter recall status

Official ID Z-1862-2026 · Official record ↗

FDA Class II · Medical device · April 29, 2026

Soft-Vu Angiographic Catheter recall — Angiodynamics, Inc.

The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.

Company / brand: Angiodynamics recalls

Affected product: Soft-Vu Angiographic Catheter recall status

Official ID Z-1861-2026 · Official record ↗

FDA Class II · Medical device · April 29, 2026

Soft-Vu Angiographic Catheter recall — Angiodynamics, Inc.

The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.

Company / brand: Angiodynamics recalls

Affected product: Soft-Vu Angiographic Catheter recall status

Official ID Z-1860-2026 · Official record ↗

FDA Class II · Medical device · April 29, 2026

Soft-Vu Angiographic Catheter recall — Angiodynamics, Inc.

The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.

Company / brand: Angiodynamics recalls

Affected product: Soft-Vu Angiographic Catheter recall status

Official ID Z-1859-2026 · Official record ↗

FDA Class II · Medical device · April 29, 2026

Soft-Vu Angiographic Catheter recall — Angiodynamics, Inc.

The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.

Company / brand: Angiodynamics recalls

Affected product: Soft-Vu Angiographic Catheter recall status

Official ID Z-1858-2026 · Official record ↗

FDA Class II · Medical device · April 29, 2026

Soft -Vu Angiographic Catheter recall — Angiodynamics, Inc.

The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.

Company / brand: Angiodynamics recalls

Affected product: Soft -Vu Angiographic Catheter recall status

Official ID Z-1857-2026 · Official record ↗

FDA Class II · Medical device · April 29, 2026

Soft-Vu Angiographic Catheter recall — Angiodynamics, Inc.

The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.

Company / brand: Angiodynamics recalls

Affected product: Soft-Vu Angiographic Catheter recall status

Official ID Z-1856-2026 · Official record ↗

FDA Class II · Medical device · April 29, 2026

Olympus Thunderbeat II Shears w/Ultrasonic Mode recall — Olympus Corporation of the Americas

Potential for detachment of a distal tip component of the device during use.

Company / brand: Olympus of the Americas recalls

Affected product: Olympus Thunderbeat II Shears w/Ultrasonic Mode recall status

Official ID Z-1854-2026 · Official record ↗

FDA Class II · Medical device · April 29, 2026

Olympus Thunderbeat II Shears w/Ultrasonic Mode recall — Olympus Corporation of the Americas

Potential for detachment of a distal tip component of the device during use.

Company / brand: Olympus of the Americas recalls

Affected product: Olympus Thunderbeat II Shears w/Ultrasonic Mode recall status

Official ID Z-1853-2026 · Official record ↗

FDA Class II · Medical device · April 29, 2026

Olympus Thunderbeat II Shears w/Ultrasonic Mode recall — Olympus Corporation of the Americas

Potential for detachment of a distal tip component of the device during use.

Company / brand: Olympus of the Americas recalls

Affected product: Olympus Thunderbeat II Shears w/Ultrasonic Mode recall status

Official ID Z-1852-2026 · Official record ↗

FDA Class II · Medical device · April 29, 2026

Olympus Thunderbeat II Shears w/Ultrasonic Mode recall — Olympus Corporation of the Americas

Potential for detachment of a distal tip component of the device during use.

Company / brand: Olympus of the Americas recalls

Affected product: Olympus Thunderbeat II Shears w/Ultrasonic Mode recall status

Official ID Z-1851-2026 · Official record ↗

FDA Class II · Medical device · April 29, 2026

Medline Kits recall — Medline Industries, LP

The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.

Company / brand: Medline Industries recalls

Affected product: Medline Kits recall status

Official ID Z-1850-2026 · Official record ↗

FDA Class II · Medical device · April 29, 2026

Medline Kits recall — Medline Industries, LP

The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.

Company / brand: Medline Industries recalls

Affected product: Medline Kits recall status

Official ID Z-1849-2026 · Official record ↗

FDA Class II · Medical device · April 29, 2026

Medline Kits recall — Medline Industries, LP

The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.

Company / brand: Medline Industries recalls

Affected product: Medline Kits recall status

Official ID Z-1848-2026 · Official record ↗

FDA Class II · Medical device · April 29, 2026

Medline Kits recall — Medline Industries, LP

The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.

Company / brand: Medline Industries recalls

Affected product: Medline Kits recall status

Official ID Z-1847-2026 · Official record ↗

FDA Class II · Medical device · April 29, 2026

Medline Kits recall — Medline Industries, LP

The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.

Company / brand: Medline Industries recalls

Affected product: Medline Kits recall status

Official ID Z-1846-2026 · Official record ↗

FDA Class II · Medical device · April 29, 2026

Medline Kits recall — Medline Industries, LP

The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.

Company / brand: Medline Industries recalls

Affected product: Medline Kits recall status

Official ID Z-1845-2026 · Official record ↗

FDA Class II · Medical device · April 29, 2026

Medline Kits recall — Medline Industries, LP

The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.

Company / brand: Medline Industries recalls

Affected product: Medline Kits recall status

Official ID Z-1844-2026 · Official record ↗

FDA Class II · Medical device · April 29, 2026

Medline Kits recall — Medline Industries, LP

The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.

Company / brand: Medline Industries recalls

Affected product: Medline Kits recall status

Official ID Z-1843-2026 · Official record ↗

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