Fresh Recalls

Medical device recalls

1,617 recent medical device recalls in our current data. Showing 1–200, newest first.

FDA Class II · Medical device · October 14, 2026

Intellijoint Navigation System recall — Intellijoint Surgical, Inc.

A navigation system used to aid in selection and positioning of orthopedic implant system components has a workstation that may contain a 15-inch MacBook Pro battery, subject to an…

Company / brand: Intellijoint Surgical recalls

Affected product: Intellijoint Navigation System recall status

Official ID Z-0119-2027 · Official record ↗

FDA Class II · Medical device · October 14, 2026

HexaVue Focus Integration System recall — Steris Corporation

A software issue may result in unintended mismatch of patient information on manually printed images. Incorrect patient information appearing on printed images could create a docum…

Company / brand: Steris recalls

Affected product: HexaVue Focus Integration System recall status

Official ID Z-0118-2027 · Official record ↗

FDA Class II · Medical device · October 14, 2026

TufTex¿ Over-the-Wire Embolectomy Catheter recall — LeMaitre Vascular, Inc.

Devices failed in process testing related to the amount of pull force it can sustain prior to the balloon components failing.

Company / brand: LeMaitre Vascular recalls

Affected product: TufTex¿ Over-the-Wire Embolectomy Catheter recall status

Official ID Z-0117-2027 · Official record ↗

FDA Class III · Medical device · October 14, 2026

T1 Patient Monitor recall — Mindray DS USA, Inc.

Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiological alarm functions

Company / brand: Mindray DS USA recalls

Affected product: T1 Patient Monitor recall status

Official ID Z-0116-2027 · Official record ↗

FDA Class III · Medical device · October 14, 2026

cPM Series Patient Monitor recall — Mindray DS USA, Inc.

Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiological alarm functions

Company / brand: Mindray DS USA recalls

Affected product: cPM Series Patient Monitor recall status

Official ID Z-0115-2027 · Official record ↗

FDA Class III · Medical device · October 14, 2026

Passport Series Patient Monitor recall — Mindray DS USA, Inc.

Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiological alarm functions

Company / brand: Mindray DS USA recalls

Affected product: Passport Series Patient Monitor recall status

Official ID Z-0114-2027 · Official record ↗

FDA Class III · Medical device · October 14, 2026

BeneView Series recall — Mindray DS USA, Inc.

Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiological alarm functions

Company / brand: Mindray DS USA recalls

Affected product: BeneView Series recall status

Official ID Z-0113-2027 · Official record ↗

FDA Class III · Medical device · October 14, 2026

Panorama and Telemetry Monitoring System recall — Mindray DS USA, Inc.

Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiological alarm functions

Company / brand: Mindray DS USA recalls

Affected product: Panorama and Telemetry Monitoring System recall status

Official ID Z-0112-2027 · Official record ↗

FDA Class III · Medical device · October 14, 2026

BeneVision Series Telemetry Monitor recall — Mindray DS USA, Inc.

Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiological alarm functions

Company / brand: Mindray DS USA recalls

Affected product: BeneVision Series Telemetry Monitor recall status

Official ID Z-0111-2027 · Official record ↗

FDA Class III · Medical device · October 14, 2026

BeneVision N1 and N-Series Patient Monitor recall — Mindray DS USA, Inc.

Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiological alarm functions

Company / brand: Mindray DS USA recalls

Affected product: BeneVision N1 and N-Series Patient Monitor recall status

Official ID Z-0110-2027 · Official record ↗

FDA Class III · Medical device · October 14, 2026

ePM Series Patient Monitor recall — Mindray DS USA, Inc.

Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiological alarm functions

Company / brand: Mindray DS USA recalls

Affected product: ePM Series Patient Monitor recall status

Official ID Z-0109-2027 · Official record ↗

FDA Class II · Medical device · October 14, 2026

Alphenix INFX-8000C/B5 recall — Canon Medical System, USA, INC.

Loosening of the bolts securing the longitudinal movement mechanism may cause the tabletop to shift, resulting in [positional/imaging/patient] misalignment and a longitudinal motio…

Company / brand: Canon Medical System recalls

Affected product: Alphenix INFX-8000C/B5 recall status

Official ID Z-0108-2027 · Official record ↗

FDA Class II · Medical device · October 14, 2026

SEDIPLAST recall — POLYMEDCO, INC. / POLYMEDCO CANCER DIAGNOSTIC PRODUCTS, LLC

During use of an affected tube, the operator may encounter increased resistance when inserting the pipette. The resulting pressure buildup may cause the tube cap to detach or be fo…

Company / brand: POLYMEDCO recalls

Affected product: SEDIPLAST recall status

Official ID Z-0107-2027 · Official record ↗

FDA Class II · Medical device · October 14, 2026

ABD HYSTERECTOMY recall — AVID Medical, Inc.

Product may be potentially contaminated with a lubricant used during the manufacturing process.

Company / brand: AVID Medical recalls

Affected product: ABD HYSTERECTOMY recall status

Official ID Z-0106-2027 · Official record ↗

FDA Class II · Medical device · October 14, 2026

GYN LAPAROSCOPY PACK recall — AVID Medical, Inc.

Product may be potentially contaminated with a lubricant used during the manufacturing process.

Company / brand: AVID Medical recalls

Affected product: GYN LAPAROSCOPY PACK recall status

Official ID Z-0105-2027 · Official record ↗

FDA Class II · Medical device · October 14, 2026

MAJOR PACK recall — AVID Medical, Inc.

Product may be potentially contaminated with a lubricant used during the manufacturing process.

Company / brand: AVID Medical recalls

Affected product: MAJOR PACK recall status

Official ID Z-0104-2027 · Official record ↗

FDA Class II · Medical device · October 14, 2026

UROLOGY MAJOR recall — AVID Medical, Inc.

Product may be potentially contaminated with a lubricant used during the manufacturing process.

Company / brand: AVID Medical recalls

Affected product: UROLOGY MAJOR recall status

Official ID Z-0103-2027 · Official record ↗

FDA Class II · Medical device · October 14, 2026

HEART PREP TRAY recall — AVID Medical, Inc.

Product may be potentially contaminated with a lubricant used during the manufacturing process.

Company / brand: AVID Medical recalls

Affected product: HEART PREP TRAY recall status

Official ID Z-0102-2027 · Official record ↗

FDA Class II · Medical device · October 14, 2026

DAVINCI LAP/GYN recall — AVID Medical, Inc.

Product may be potentially contaminated with a lubricant used during the manufacturing process.

Company / brand: AVID Medical recalls

Affected product: DAVINCI LAP/GYN recall status

Official ID Z-0101-2027 · Official record ↗

FDA Class II · Medical device · October 14, 2026

PLASTICS TRAY recall — AVID Medical, Inc.

Product may be potentially contaminated with a lubricant used during the manufacturing process.

Company / brand: AVID Medical recalls

Affected product: PLASTICS TRAY recall status

Official ID Z-0100-2027 · Official record ↗

FDA Class II · Medical device · October 14, 2026

LAPAROSCOPIC PROSTATECTOMY recall — AVID Medical, Inc.

Product may be potentially contaminated with a lubricant used during the manufacturing process.

Company / brand: AVID Medical recalls

Affected product: LAPAROSCOPIC PROSTATECTOMY recall status

Official ID Z-0099-2027 · Official record ↗

FDA Class II · Medical device · October 14, 2026

ROBOTIC PROSTATECTOMY PACK recall — AVID Medical, Inc.

Product may be potentially contaminated with a lubricant used during the manufacturing process.

Company / brand: AVID Medical recalls

Affected product: ROBOTIC PROSTATECTOMY PACK recall status

Official ID Z-0098-2027 · Official record ↗

FDA Class II · Medical device · October 14, 2026

PACK OPEN HEART CFH recall — AVID Medical, Inc.

Product may be potentially contaminated with a lubricant used during the manufacturing process.

Company / brand: AVID Medical recalls

Affected product: PACK OPEN HEART CFH recall status

Official ID Z-0097-2027 · Official record ↗

FDA Class II · Medical device · October 14, 2026

CRANIOTOMY PACK recall — AVID Medical, Inc.

Product may be potentially contaminated with a lubricant used during the manufacturing process.

Company / brand: AVID Medical recalls

Affected product: CRANIOTOMY PACK recall status

Official ID Z-0096-2027 · Official record ↗

FDA Class II · Medical device · October 14, 2026

ENDOVASCULAR PACK recall — AVID Medical, Inc.

Product may be potentially contaminated with a lubricant used during the manufacturing process.

Company / brand: AVID Medical recalls

Affected product: ENDOVASCULAR PACK recall status

Official ID Z-0095-2027 · Official record ↗

FDA Class II · Medical device · October 14, 2026

ADULT HEART TRAY SHANDS JACKS recall — AVID Medical, Inc.

Product may be potentially contaminated with a lubricant used during the manufacturing process.

Company / brand: AVID Medical recalls

Affected product: ADULT HEART TRAY SHANDS JACKS recall status

Official ID Z-0094-2027 · Official record ↗

FDA Class II · Medical device · October 14, 2026

GYN LAPAROSCOPY/LAPAROTOMY recall — AVID Medical, Inc.

Product may be potentially contaminated with a lubricant used during the manufacturing process.

Company / brand: AVID Medical recalls

Affected product: GYN LAPAROSCOPY/LAPAROTOMY recall status

Official ID Z-0093-2027 · Official record ↗

FDA Class II · Medical device · October 14, 2026

DAVINCI TRUCUSTOM BUNDLE recall — AVID Medical, Inc.

Product may be potentially contaminated with a lubricant used during the manufacturing process.

Company / brand: AVID Medical recalls

Affected product: DAVINCI TRUCUSTOM BUNDLE recall status

Official ID Z-0092-2027 · Official record ↗

FDA Class II · Medical device · October 14, 2026

Onkos Surgical Inc recall — Onkos Surgical, Inc.

Personalized pelvic implants inadvertently mixed up and distributed to incorrect customers.

Company / brand: Onkos Surgical recalls

Affected product: Onkos Surgical Inc recall status

Official ID Z-0091-2027 · Official record ↗

FDA Class II · Medical device · October 14, 2026

Onkos Surgical Inc recall — Onkos Surgical, Inc.

Personalized pelvic implants inadvertently mixed up and distributed to incorrect customers.

Company / brand: Onkos Surgical recalls

Affected product: Onkos Surgical Inc recall status

Official ID Z-0090-2027 · Official record ↗

FDA Class II · Medical device · October 14, 2026

Product Name recall — Nihon Kohden America LLC

Due to a cybersecurity issue associate with a NULL Pointer Dereferences vulnerabiity. If exploited would potentially cause disruption of the centralized monitoring of multiple beds…

Company / brand: Nihon Kohden America recalls

Affected product: Product Name recall status

Official ID Z-0089-2027 · Official record ↗

FDA Class II · Medical device · October 14, 2026

Brand Name recall — Medtronic MiniMed, Inc.

Some MiniMed Flex insulin pumps were released with missing (i.e., devices with no result or abort test results are presumed to have failed) or failed verification test results in o…

Company / brand: Medtronic MiniMed recalls

Affected product: Brand Name recall status

Official ID Z-0088-2027 · Official record ↗

FDA Class II · Medical device · October 14, 2026

Rollator recall — Medline Industries, LP

The front fork stem bolt/wheel assembly may disconnect from the rollator frame tubing. If the front fork stem bolt/wheel assembly disconnects from the rollator frame tubing, the fr…

Company / brand: Medline Industries recalls

Affected product: Rollator recall status

Official ID Z-0087-2027 · Official record ↗

FDA Class II · Medical device · October 14, 2026

Rollator recall — Medline Industries, LP

The front fork stem bolt/wheel assembly may disconnect from the rollator frame tubing. If the front fork stem bolt/wheel assembly disconnects from the rollator frame tubing, the fr…

Company / brand: Medline Industries recalls

Affected product: Rollator recall status

Official ID Z-0086-2027 · Official record ↗

FDA Class II · Medical device · October 14, 2026

BARD EP XT DECAPOLAR STEERABLE recall — Stryker Sustainability Solutions

Diagnostic electrophysiology (EP) catheter may have a breached sterile barrier on the straight seal side of the primary pouch, which if used could lead to particulate embolization,…

Company / brand: Stryker Sustainability Solutions recalls

Affected product: BARD EP XT DECAPOLAR STEERABLE recall status

Official ID Z-0085-2027 · Official record ↗

FDA Class II · Medical device · October 14, 2026

DxC 500 AU Clinical Chemistry Analyzers recall — Beckman Coulter Inc.

Beckman Coulter has identified a software issue affecting DxC 500 AU Clinical Analyzers when testing plasma samples. Following user configuration of a Clinical Chemistry test to us…

Company / brand: Beckman Coulter recalls

Affected product: DxC 500 AU Clinical Chemistry Analyzers recall status

Official ID Z-0084-2027 · Official record ↗

FDA Class II · Medical device · October 14, 2026

DxC 500i Clinical Analyzer Modules recall — Beckman Coulter Inc.

Beckman Coulter has identified a software issue affecting DxC 500i Clinical Analyzers when testing plasma samples. Following user configuration of a Clinical Chemistry test to use …

Company / brand: Beckman Coulter recalls

Affected product: DxC 500i Clinical Analyzer Modules recall status

Official ID Z-0083-2027 · Official record ↗

FDA Class II · Medical device · October 14, 2026

Sperm Ab ELISA recall — DRG International, Inc.

Potential for false negative patient results.

Company / brand: DRG International recalls

Affected product: Sperm Ab ELISA recall status

Official ID Z-0082-2027 · Official record ↗

FDA Class II · Medical device · October 14, 2026

Battle Bandage recall — Safeguard US Operating LLC

Compression bandage may be degraded, which may cause unwanted foreign material to be introduced inside the wound, which may lead to wound exploration and irrigation, formation of s…

Company / brand: Safeguard US Operating recalls

Affected product: Battle Bandage recall status

Official ID Z-0081-2027 · Official record ↗

FDA Class II · Medical device · October 14, 2026

Glypto Device recall — Limitless Cryo Spa LLC

Lack of 510(k) clearance.

Company / brand: Limitless Cryo Spa recalls

Affected product: Glypto Device recall status

Official ID Z-0080-2027 · Official record ↗

FDA Class II · Medical device · October 14, 2026

Presource Packs containing Medtronic Microstream Components recall — Cardinal Health 200, LLC

Kits contain Microstream components. Medtronic issued an update to the Instructions for Use of these components due reports of difficulty in disconnecting the adapter from the pati…

Company / brand: Cardinal Health 200 recalls

Affected product: Presource Packs containing Medtronic Microstream Components recall status

Official ID Z-0079-2027 · Official record ↗

FDA Class II · Medical device · October 14, 2026

Spectral CT and Spectral CT 7500 RT recall — PHILIPS MEDICAL SYSTEMS

Software issues may affect the safety and performance of Spectral CT system(s). The issues may result in image artifacts, wrong slice thickness, or unintended system motion.

Company / brand: PHILIPS MEDICAL SYSTEMS recalls

Affected product: Spectral CT and Spectral CT 7500 RT recall status

Official ID Z-0078-2027 · Official record ↗

FDA Class II · Medical device · October 14, 2026

HALYARD Laparoscopy Comprehensive Pack II REF recall — GRI Medical & Electronic Technology Co., Ltd.

Laparoscopy packs labeled as "latex free" were found to contain a latex urethral catheter

Company / brand: GRI Medical & Electronic Technology Co recalls

Affected product: HALYARD Laparoscopy Comprehensive Pack II REF recall status

Official ID Z-0077-2027 · Official record ↗

FDA Class II · Medical device · October 14, 2026

Brand Name recall — QUANTUM OPS Inc

Due to a manufacturing issue (inadequate weld) for patient head positioning system.

Company / brand: QUANTUM OPS recalls

Affected product: Brand Name recall status

Official ID Z-0076-2027 · Official record ↗

FDA Class II · Medical device · October 14, 2026

VERIFY Biological Steam Test Pack Model/Catalog Number recall — Steris Corporation

Geobacillus stearothermophilus spore population in affected products may fall below minimum shelf life specification. When used to monitor steam sterilization cycles, the potential…

Company / brand: Steris recalls

Affected product: VERIFY Biological Steam Test Pack Model/Catalog Number recall status

Official ID Z-0075-2027 · Official record ↗

FDA Class II · Medical device · October 14, 2026

VERIFY Biological Steam Test Pack Model/Catalog Number recall — Steris Corporation

Geobacillus stearothermophilus spore population in affected products may fall below minimum shelf life specification. When used to monitor steam sterilization cycles, the potential…

Company / brand: Steris recalls

Affected product: VERIFY Biological Steam Test Pack Model/Catalog Number recall status

Official ID Z-0074-2027 · Official record ↗

FDA Class II · Medical device · October 14, 2026

VERIFY Dual Species Self-Contained Biological Indicator Model/Catalog Number recall — Steris Corporation

Geobacillus stearothermophilus spore population in affected products may fall below minimum shelf life specification. When used to monitor steam sterilization cycles, the potential…

Company / brand: Steris recalls

Affected product: VERIFY Dual Species Self-Contained Biological Indicator Model/Catalog Number recall status

Official ID Z-0073-2027 · Official record ↗

FDA Class II · Medical device · October 14, 2026

VERIFY Dual Species Self-Contained Biological Indicator Model/Catalog Number recall — Steris Corporation

Geobacillus stearothermophilus spore population in affected products may fall below minimum shelf life specification. When used to monitor steam sterilization cycles, the potential…

Company / brand: Steris recalls

Affected product: VERIFY Dual Species Self-Contained Biological Indicator Model/Catalog Number recall status

Official ID Z-0072-2027 · Official record ↗

FDA Class II · Medical device · October 14, 2026

VERIFY Biological/Integrator Challenge Pack Model/Catalog Number recall — Steris Corporation

Geobacillus stearothermophilus spore population in affected products may fall below minimum shelf life specification. When used to monitor steam sterilization cycles, the potential…

Company / brand: Steris recalls

Affected product: VERIFY Biological/Integrator Challenge Pack Model/Catalog Number recall status

Official ID Z-0071-2027 · Official record ↗

FDA Class II · Medical device · October 14, 2026

VERIFY Biological/Integrator Challenge Pack Model/Catalog Number recall — Steris Corporation

Geobacillus stearothermophilus spore population in affected products may fall below minimum shelf life specification. When used to monitor steam sterilization cycles, the potential…

Company / brand: Steris recalls

Affected product: VERIFY Biological/Integrator Challenge Pack Model/Catalog Number recall status

Official ID Z-0070-2027 · Official record ↗

FDA Class III · Medical device · October 14, 2026

Generic Name recall — Medical Action Industries, Inc. 306

An internal data-entry error caused kit lot 333606 to be labeled with an expiration date of March 31, 2027, instead of February 28, 2027.

Company / brand: Medical Action Industries recalls

Affected product: Generic Name recall status

Official ID Z-0069-2027 · Official record ↗

FDA Class II · Medical device · October 7, 2026

Atellica CH Revised C-Reactive Protein (RCRP) recall — Siemens Healthcare Diagnostics, Inc.

The potential for falsely elevated results.

Company / brand: Siemens Healthcare Diagnostics recalls

Affected product: Atellica CH Revised C-Reactive Protein (RCRP) recall status

Official ID Z-3335-2026 · Official record ↗

FDA Class II · Medical device · October 7, 2026

CHARLOTTE CLAW Screw recall — Wright Medical Technology, Inc.

Screws, intended for use with polyaxial compression plating system intended for foot osteotomies, was manufactured with missing threads on the screwheads, which if used would preve…

Company / brand: Wright Medical Technology recalls

Affected product: CHARLOTTE CLAW Screw recall status

Official ID Z-3334-2026 · Official record ↗

FDA Class II · Medical device · October 7, 2026

HOPKINS Telescope 30¿ recall — Karl Storz Endoscopy

Due to incorrect inside packaging label for eyepiece.

Company / brand: Karl Storz Endoscopy recalls

Affected product: HOPKINS Telescope 30¿ recall status

Official ID Z-3333-2026 · Official record ↗

FDA Class II · Medical device · October 7, 2026

Systems/units containing affected software/SQL BECKMAN COULTER CHEMISTRY ANALYZER AU480 RE recall — Beckman Coulter Mishima K.K.

Certain AU480 chemistry analyzers, with Windows 10 IoT Enterprise 2021 LTSC PCs, may output the message System Stopped By Fatal Error: DBConnectionError AlarmDB when launching the …

Company / brand: Beckman Coulter Mishima K.K recalls

Affected product: Systems/units containing affected software/SQL BECKMAN COULTER CHEMISTRY ANALYZER AU480 RE recall status

Official ID Z-3332-2026 · Official record ↗

FDA Class II · Medical device · October 7, 2026

Brand Name recall — Penumbra Inc.

Due to manufacturing issues reperfusion catheters may fracture.

Company / brand: Penumbra recalls

Affected product: Brand Name recall status

Official ID Z-3331-2026 · Official record ↗

FDA Class II · Medical device · October 7, 2026

Brand Name recall — Tandem Diabetes Care, Inc.

A beta (early-release) version of the iOS application, version 2.13 (TestFlight) had a software issue preventing successful pairing of the t:slim application with Abbott FreeStyle …

Company / brand: Tandem Diabetes Care recalls

Affected product: Brand Name recall status

Official ID Z-3330-2026 · Official record ↗

FDA Class II · Medical device · October 7, 2026

Olympus Tripp-Lite P580-025 25ft DisplayPort Cable recall — Olympus Corporation of the Americas

While in the high-power operating mode, a video dropout/blackout may occur when using a particular accessory cable.

Company / brand: Olympus of the Americas recalls

Affected product: Olympus Tripp-Lite P580-025 25ft DisplayPort Cable recall status

Official ID Z-3329-2026 · Official record ↗

FDA Class II · Medical device · October 7, 2026

Brand Name recall — SPECTRUM MEDICAL SRL

Due to blood-to-glycol leak in the heat exchanger.

Company / brand: SPECTRUM MEDICAL SRL recalls

Affected product: Brand Name recall status

Official ID Z-3328-2026 · Official record ↗

FDA Class II · Medical device · October 7, 2026

Brand Name recall — SPECTRUM MEDICAL SRL

Due to blood-to-glycol leak in the heat exchanger.

Company / brand: SPECTRUM MEDICAL SRL recalls

Affected product: Brand Name recall status

Official ID Z-3327-2026 · Official record ↗

FDA Class II · Medical device · October 7, 2026

Pipeline Flex Embolization Device with Shield Technology REF PED2-300-12 UDI-DI code recall — Micro Therapeutics, Inc.

Due to incorrect label/product dimensions. Product is supposed to be 3.00 mm in diameter, but unit is packaging was a 2.50 mm in diameter.

Company / brand: Micro Therapeutics recalls

Affected product: Pipeline Flex Embolization Device with Shield Technology REF PED2-300-12 UDI-DI code recall status

Official ID Z-3326-2026 · Official record ↗

FDA Class II · Medical device · October 7, 2026

Intrapulmonary Percussive Ventilation recall — Percussionaire Corporation

Labeling updated warning not to use Intrapulmonary percussive ventilation (IPV) in conjunction with volatile anesthetic delivery systems because IPV may alter controlled delivery o…

Company / brand: Percussionaire recalls

Affected product: Intrapulmonary Percussive Ventilation recall status

Official ID Z-3325-2026 · Official record ↗

FDA Class II · Medical device · October 7, 2026

Travel Air recall — Percussionaire Corporation

Labeling updated warning not to use Intrapulmonary percussive ventilation (IPV) in conjunction with volatile anesthetic delivery systems because IPV may alter controlled delivery o…

Company / brand: Percussionaire recalls

Affected product: Travel Air recall status

Official ID Z-3324-2026 · Official record ↗

FDA Class II · Medical device · October 7, 2026

Impulsator recall — Percussionaire Corporation

Labeling updated warning not to use Intrapulmonary percussive ventilation (IPV) in conjunction with volatile anesthetic delivery systems because IPV may alter controlled delivery o…

Company / brand: Percussionaire recalls

Affected product: Impulsator recall status

Official ID Z-3323-2026 · Official record ↗

FDA Class II · Medical device · October 7, 2026

Intrapulmonary Percussive Ventilation recall — Percussionaire Corporation

Labeling updated warning not to use Intrapulmonary percussive ventilation (IPV) in conjunction with volatile anesthetic delivery systems because IPV may alter controlled delivery o…

Company / brand: Percussionaire recalls

Affected product: Intrapulmonary Percussive Ventilation recall status

Official ID Z-3322-2026 · Official record ↗

FDA Class II · Medical device · October 7, 2026

Intrapulmonary Percussive Ventilation recall — Percussionaire Corporation

Labeling updated warning not to use Intrapulmonary percussive ventilation (IPV) in conjunction with volatile anesthetic delivery systems because IPV may alter controlled delivery o…

Company / brand: Percussionaire recalls

Affected product: Intrapulmonary Percussive Ventilation recall status

Official ID Z-3321-2026 · Official record ↗

FDA Class II · Medical device · October 7, 2026

In-Line Valve recall — Percussionaire Corporation

Labeling updated warning not to use Intrapulmonary percussive ventilation (IPV) in conjunction with volatile anesthetic delivery systems because IPV may alter controlled delivery o…

Company / brand: Percussionaire recalls

Affected product: In-Line Valve recall status

Official ID Z-3320-2026 · Official record ↗

FDA Class II · Medical device · October 7, 2026

Intrapulmonary Percussive Ventilation recall — Percussionaire Corporation

Labeling updated warning not to use Intrapulmonary percussive ventilation (IPV) in conjunction with volatile anesthetic delivery systems because IPV may alter controlled delivery o…

Company / brand: Percussionaire recalls

Affected product: Intrapulmonary Percussive Ventilation recall status

Official ID Z-3319-2026 · Official record ↗

FDA Class II · Medical device · October 7, 2026

Evolution upgrade 1 recall — Philips North America

When exporting diffusion tensor imaging (DTI) scans from a MR system using the Enhanced MR DICOM format, the exports contain incorrect data (diffusion directions). If the Enhanced …

Company / brand: Philips North America recalls

Affected product: Evolution upgrade 1 recall status

Official ID Z-3318-2026 · Official record ↗

FDA Class II · Medical device · October 7, 2026

Upgrade to MR 7700 recall — Philips North America

When exporting diffusion tensor imaging (DTI) scans from a MR system using the Enhanced MR DICOM format, the exports contain incorrect data (diffusion directions). If the Enhanced …

Company / brand: Philips North America recalls

Affected product: Upgrade to MR 7700 recall status

Official ID Z-3317-2026 · Official record ↗

FDA Class II · Medical device · October 7, 2026

Upgrade dStream recall — Philips North America

When exporting diffusion tensor imaging (DTI) scans from a MR system using the Enhanced MR DICOM format, the exports contain incorrect data (diffusion directions). If the Enhanced …

Company / brand: Philips North America recalls

Affected product: Upgrade dStream recall status

Official ID Z-3316-2026 · Official record ↗

FDA Class II · Medical device · October 7, 2026

SmartPath to MR 7700 recall — Philips North America

When exporting diffusion tensor imaging (DTI) scans from a MR system using the Enhanced MR DICOM format, the exports contain incorrect data (diffusion directions). If the Enhanced …

Company / brand: Philips North America recalls

Affected product: SmartPath to MR 7700 recall status

Official ID Z-3315-2026 · Official record ↗

FDA Class II · Medical device · October 7, 2026

SmartPath to dStream for 1 recall — Philips North America

When exporting diffusion tensor imaging (DTI) scans from a MR system using the Enhanced MR DICOM format, the exports contain incorrect data (diffusion directions). If the Enhanced …

Company / brand: Philips North America recalls

Affected product: SmartPath to dStream for 1 recall status

Official ID Z-3314-2026 · Official record ↗

FDA Class II · Medical device · October 7, 2026

MR 7700 recall — Philips North America

When exporting diffusion tensor imaging (DTI) scans from a MR system using the Enhanced MR DICOM format, the exports contain incorrect data (diffusion directions). If the Enhanced …

Company / brand: Philips North America recalls

Affected product: MR 7700 recall status

Official ID Z-3313-2026 · Official record ↗

FDA Class II · Medical device · October 7, 2026

MR 5300 recall — Philips North America

When exporting diffusion tensor imaging (DTI) scans from a MR system using the Enhanced MR DICOM format, the exports contain incorrect data (diffusion directions). If the Enhanced …

Company / brand: Philips North America recalls

Affected product: MR 5300 recall status

Official ID Z-3312-2026 · Official record ↗

FDA Class II · Medical device · October 7, 2026

Ingenia Elition S and Ingenia Elition X recall — Philips North America

When exporting diffusion tensor imaging (DTI) scans from a MR system using the Enhanced MR DICOM format, the exports contain incorrect data (diffusion directions). If the Enhanced …

Company / brand: Philips North America recalls

Affected product: Ingenia Elition S and Ingenia Elition X recall status

Official ID Z-3311-2026 · Official record ↗

FDA Class II · Medical device · October 7, 2026

Ingenia Ambition S and Ingenia Ambition X recall — Philips North America

When exporting diffusion tensor imaging (DTI) scans from a MR system using the Enhanced MR DICOM format, the exports contain incorrect data (diffusion directions). If the Enhanced …

Company / brand: Philips North America recalls

Affected product: Ingenia Ambition S and Ingenia Ambition X recall status

Official ID Z-3310-2026 · Official record ↗

FDA Class II · Medical device · October 7, 2026

Ingenia 3 recall — Philips North America

When exporting diffusion tensor imaging (DTI) scans from a MR system using the Enhanced MR DICOM format, the exports contain incorrect data (diffusion directions). If the Enhanced …

Company / brand: Philips North America recalls

Affected product: Ingenia 3 recall status

Official ID Z-3309-2026 · Official record ↗

FDA Class II · Medical device · October 7, 2026

Ingenia 1 recall — Philips North America

When exporting diffusion tensor imaging (DTI) scans from a MR system using the Enhanced MR DICOM format, the exports contain incorrect data (diffusion directions). If the Enhanced …

Company / brand: Philips North America recalls

Affected product: Ingenia 1 recall status

Official ID Z-3308-2026 · Official record ↗

FDA Class II · Medical device · October 7, 2026

Ingenia Blue Seal SE and Blue Seal XE recall — Philips North America

When exporting diffusion tensor imaging (DTI) scans from a MR system using the Enhanced MR DICOM format, the exports contain incorrect data (diffusion directions). If the Enhanced …

Company / brand: Philips North America recalls

Affected product: Ingenia Blue Seal SE and Blue Seal XE recall status

Official ID Z-3307-2026 · Official record ↗

FDA Class II · Medical device · October 7, 2026

NOxBOXi Nitric Oxide Delivery System recall — NOXBOX LTD

Potential for irregular oxygen readings due to a manufacturing issue affecting certain oxygen sensors.

Company / brand: NOXBOX recalls

Affected product: NOxBOXi Nitric Oxide Delivery System recall status

Official ID Z-3306-2026 · Official record ↗

FDA Class II · Medical device · October 7, 2026

Embosphere 500-700 micrometer 2 mL Syringe Sterile Steam recall — Merit Medical Systems, Inc.

Microspheres used in embolization of tumors, prostatic arteries, arteriovenous malformations, and blood vessels may have holes in packaging that may affect the sterile barrier, whi…

Company / brand: Merit Medical Systems recalls

Affected product: Embosphere 500-700 micrometer 2 mL Syringe Sterile Steam recall status

Official ID Z-3305-2026 · Official record ↗

FDA Class II · Medical device · October 7, 2026

PALACOS MV pro 40 recall — Heraeus Medical GmbH (Dental Division)

Potential for monomer liquid leakage.

Company / brand: Heraeus Medical (Dental Division) recalls

Affected product: PALACOS MV pro 40 recall status

Official ID Z-3304-2026 · Official record ↗

FDA Class II · Medical device · October 7, 2026

PALACOS MV+G pro 40 recall — Heraeus Medical GmbH (Dental Division)

Potential for monomer liquid leakage.

Company / brand: Heraeus Medical (Dental Division) recalls

Affected product: PALACOS MV+G pro 40 recall status

Official ID Z-3303-2026 · Official record ↗

FDA Class II · Medical device · October 7, 2026

PALACOS R+G pro 40 recall — Heraeus Medical GmbH (Dental Division)

Potential for monomer liquid leakage.

Company / brand: Heraeus Medical (Dental Division) recalls

Affected product: PALACOS R+G pro 40 recall status

Official ID Z-3302-2026 · Official record ↗

FDA Class II · Medical device · October 7, 2026

PALACOS R pro 40 recall — Heraeus Medical GmbH (Dental Division)

Potential for monomer liquid leakage.

Company / brand: Heraeus Medical (Dental Division) recalls

Affected product: PALACOS R pro 40 recall status

Official ID Z-3301-2026 · Official record ↗

FDA Class II · Medical device · October 7, 2026

Olympus M3 Gold Autoclavable Lateral Telescope 70 recall — Olympus Corporation of the Americas

There are identified discrepancies between the sterilization parameters listed in the Instructions for Use and the sterilization parameters listed in the Japanese package insert.

Company / brand: Olympus of the Americas recalls

Affected product: Olympus M3 Gold Autoclavable Lateral Telescope 70 recall status

Official ID Z-3300-2026 · Official record ↗

FDA Class II · Medical device · October 7, 2026

Olympus M3 Gold Autoclavable Foroblique Telescope 30 recall — Olympus Corporation of the Americas

There are identified discrepancies between the sterilization parameters listed in the Instructions for Use and the sterilization parameters listed in the Japanese package insert.

Company / brand: Olympus of the Americas recalls

Affected product: Olympus M3 Gold Autoclavable Foroblique Telescope 30 recall status

Official ID Z-3299-2026 · Official record ↗

FDA Class II · Medical device · October 7, 2026

Presource Packs Containing Stryker StrykeFlow PS and AHTO tube sets recall — Cardinal Health 200, LLC

The kits contain tube sets with handpieces that may leak during use. The impacted devices can have the following failures: fluid leakage from the hand piece that can pool on the fl…

Company / brand: Cardinal Health 200 recalls

Affected product: Presource Packs Containing Stryker StrykeFlow PS and AHTO tube sets recall status

Official ID Z-3298-2026 · Official record ↗

FDA Class II · Medical device · October 7, 2026

Presource Packs Containing Stryker StrykeFlow PS and AHTO tube sets recall — Cardinal Health 200, LLC

The kits contain tube sets with handpieces that may leak during use. The impacted devices can have the following failures: fluid leakage from the hand piece that can pool on the fl…

Company / brand: Cardinal Health 200 recalls

Affected product: Presource Packs Containing Stryker StrykeFlow PS and AHTO tube sets recall status

Official ID Z-3297-2026 · Official record ↗

FDA Class II · Medical device · October 7, 2026

Presource Packs Containing Stryker StrykeFlow PS and AHTO tube sets recall — Cardinal Health 200, LLC

The kits contain tube sets with handpieces that may leak during use. The impacted devices can have the following failures: fluid leakage from the hand piece that can pool on the fl…

Company / brand: Cardinal Health 200 recalls

Affected product: Presource Packs Containing Stryker StrykeFlow PS and AHTO tube sets recall status

Official ID Z-3296-2026 · Official record ↗

FDA Class II · Medical device · October 7, 2026

Presource Packs Containing Stryker StrykeFlow PS and AHTO tube sets recall — Cardinal Health 200, LLC

The kits contain tube sets with handpieces that may leak during use. The impacted devices can have the following failures: fluid leakage from the hand piece that can pool on the fl…

Company / brand: Cardinal Health 200 recalls

Affected product: Presource Packs Containing Stryker StrykeFlow PS and AHTO tube sets recall status

Official ID Z-3295-2026 · Official record ↗

FDA Class II · Medical device · October 7, 2026

Medical convenience kits containing BD CliniClean Pericare Wipes within BD Urinary Cathete recall — American Contract Systems Inc

Kits contain manufacturer-recalled perineal care (pericare) wipes within urinary catheter trays, which may be contaminated with a lubricant used during the manufacturing process. U…

Company / brand: American Contract Systems recalls

Affected product: Medical convenience kits containing BD CliniClean Pericare Wipes within BD Urinary Cathete recall status

Official ID Z-3294-2026 · Official record ↗

FDA Class II · Medical device · October 7, 2026

Medical convenience kits containing BD CliniClean Pericare Wipes within BD Urinary Cathete recall — American Contract Systems Inc

Kits contain manufacturer-recalled perineal care (pericare) wipes within urinary catheter trays, which may be contaminated with a lubricant used during the manufacturing process. U…

Company / brand: American Contract Systems recalls

Affected product: Medical convenience kits containing BD CliniClean Pericare Wipes within BD Urinary Cathete recall status

Official ID Z-3293-2026 · Official record ↗

FDA Class II · Medical device · October 7, 2026

Medical convenience kits containing BD CliniClean Pericare Wipes within BD Urinary Cathete recall — American Contract Systems Inc

Kits contain manufacturer-recalled perineal care (pericare) wipes within urinary catheter trays, which may be contaminated with a lubricant used during the manufacturing process. U…

Company / brand: American Contract Systems recalls

Affected product: Medical convenience kits containing BD CliniClean Pericare Wipes within BD Urinary Cathete recall status

Official ID Z-3292-2026 · Official record ↗

FDA Class II · Medical device · October 7, 2026

Brand Name recall — American Nitrile Operations Llc

Gloves may exhibit defects such as tears, missing fingers, and debris. Use of defective gloves may lead to healthcare personnel and patient exposure to infectious pathogens leading…

Company / brand: American Nitrile Operations recalls

Affected product: Brand Name recall status

Official ID Z-3291-2026 · Official record ↗

FDA Class II · Medical device · October 7, 2026

Brand Name recall — American Nitrile Operations Llc

Gloves may exhibit defects such as tears, missing fingers, and debris. Use of defective gloves may lead to healthcare personnel and patient exposure to infectious pathogens leading…

Company / brand: American Nitrile Operations recalls

Affected product: Brand Name recall status

Official ID Z-3290-2026 · Official record ↗

FDA Class II · Medical device · October 7, 2026

Brand Name recall — American Nitrile Operations Llc

Gloves may exhibit defects such as tears, missing fingers, and debris. Use of defective gloves may lead to healthcare personnel and patient exposure to infectious pathogens leading…

Company / brand: American Nitrile Operations recalls

Affected product: Brand Name recall status

Official ID Z-3289-2026 · Official record ↗

FDA Class II · Medical device · October 7, 2026

Positron Emission Tomography and Computed Tomography System recall — Shanghai United Imaging Healthcare Co., Ltd.

Positron emission tomography and computed tomography x-ray systems have a software problem when Split or Local function is enabled, and multiple RIS exams are merged into a single …

Company / brand: Shanghai United Imaging Healthcare Co recalls

Affected product: Positron Emission Tomography and Computed Tomography System recall status

Official ID Z-3288-2026 · Official record ↗

FDA Class II · Medical device · October 7, 2026

Positron Emission Tomography and Computed Tomography System recall — Shanghai United Imaging Healthcare Co., Ltd.

Positron emission tomography and computed tomography x-ray systems have a software problem when Split or Local function is enabled, and multiple RIS exams are merged into a single …

Company / brand: Shanghai United Imaging Healthcare Co recalls

Affected product: Positron Emission Tomography and Computed Tomography System recall status

Official ID Z-3287-2026 · Official record ↗

FDA Class II · Medical device · October 7, 2026

Positron Emission Tomography and Computed Tomography System recall — Shanghai United Imaging Healthcare Co., Ltd.

Positron emission tomography and computed tomography x-ray systems have a software problem when Split or Local function is enabled, and multiple RIS exams are merged into a single …

Company / brand: Shanghai United Imaging Healthcare Co recalls

Affected product: Positron Emission Tomography and Computed Tomography System recall status

Official ID Z-3286-2026 · Official record ↗

FDA Class II · Medical device · October 7, 2026

Positron Emission Tomography and Computed Tomography System recall — Shanghai United Imaging Healthcare Co., Ltd.

Positron emission tomography and computed tomography x-ray systems have a software problem when Split or Local function is enabled, and multiple RIS exams are merged into a single …

Company / brand: Shanghai United Imaging Healthcare Co recalls

Affected product: Positron Emission Tomography and Computed Tomography System recall status

Official ID Z-3285-2026 · Official record ↗

FDA Class II · Medical device · October 7, 2026

Positron Emission Tomography and Computed Tomography System recall — Shanghai United Imaging Healthcare Co., Ltd.

Positron emission tomography and computed tomography x-ray systems have a software problem when Split or Local function is enabled, and multiple RIS exams are merged into a single …

Company / brand: Shanghai United Imaging Healthcare Co recalls

Affected product: Positron Emission Tomography and Computed Tomography System recall status

Official ID Z-3284-2026 · Official record ↗

FDA Class II · Medical device · October 7, 2026

Positron Emission Tomography and Computed Tomography System recall — Shanghai United Imaging Healthcare Co., Ltd.

Positron emission tomography and computed tomography x-ray systems have a software problem when Split or Local function is enabled, and multiple RIS exams are merged into a single …

Company / brand: Shanghai United Imaging Healthcare Co recalls

Affected product: Positron Emission Tomography and Computed Tomography System recall status

Official ID Z-3283-2026 · Official record ↗

FDA Class II · Medical device · October 7, 2026

Computed Tomography X-ray System recall — Shanghai United Imaging Healthcare Co., Ltd.

Positron emission tomography and computed tomography x-ray systems have a software problem when Split or Local function is enabled, and multiple RIS exams are merged into a single …

Company / brand: Shanghai United Imaging Healthcare Co recalls

Affected product: Computed Tomography X-ray System recall status

Official ID Z-3282-2026 · Official record ↗

FDA Class II · Medical device · October 7, 2026

Computed Tomography X-ray System recall — Shanghai United Imaging Healthcare Co., Ltd.

Positron emission tomography and computed tomography x-ray systems have a software problem when Split or Local function is enabled, and multiple RIS exams are merged into a single …

Company / brand: Shanghai United Imaging Healthcare Co recalls

Affected product: Computed Tomography X-ray System recall status

Official ID Z-3281-2026 · Official record ↗

FDA Class II · Medical device · October 7, 2026

Computed Tomography X-ray System recall — Shanghai United Imaging Healthcare Co., Ltd.

Positron emission tomography and computed tomography x-ray systems have a software problem when Split or Local function is enabled, and multiple RIS exams are merged into a single …

Company / brand: Shanghai United Imaging Healthcare Co recalls

Affected product: Computed Tomography X-ray System recall status

Official ID Z-3280-2026 · Official record ↗

FDA Class II · Medical device · October 7, 2026

Computed Tomography X-ray System recall — Shanghai United Imaging Healthcare Co., Ltd.

Positron emission tomography and computed tomography x-ray systems have a software problem when Split or Local function is enabled, and multiple RIS exams are merged into a single …

Company / brand: Shanghai United Imaging Healthcare Co recalls

Affected product: Computed Tomography X-ray System recall status

Official ID Z-3279-2026 · Official record ↗

FDA Class II · Medical device · October 7, 2026

Computed Tomography X-ray System recall — Shanghai United Imaging Healthcare Co., Ltd.

Positron emission tomography and computed tomography x-ray systems have a software problem when Split or Local function is enabled, and multiple RIS exams are merged into a single …

Company / brand: Shanghai United Imaging Healthcare Co recalls

Affected product: Computed Tomography X-ray System recall status

Official ID Z-3278-2026 · Official record ↗

FDA Class II · Medical device · October 7, 2026

Computed Tomography X-ray System recall — Shanghai United Imaging Healthcare Co., Ltd.

Positron emission tomography and computed tomography x-ray systems have a software problem when Split or Local function is enabled, and multiple RIS exams are merged into a single …

Company / brand: Shanghai United Imaging Healthcare Co recalls

Affected product: Computed Tomography X-ray System recall status

Official ID Z-3277-2026 · Official record ↗

FDA Class II · Medical device · October 7, 2026

Philips IntraSight Plus REF recall — Volcano Corp

Software system may associate image data from one patient with another patient's record, potentially resulting in incorrect diagnosis or treatment.

Company / brand: Volcano recalls

Affected product: Philips IntraSight Plus REF recall status

Official ID Z-3276-2026 · Official record ↗

FDA Class II · Medical device · October 7, 2026

EnCor EnCompass Breast Biopsy and Tissue Removal System Console (model number recall — Bard Peripheral Vascular Inc

Breast biopsy and tissue removal system may experience the following errors: 1) Probe calibration and /or handheld driver failure (code HH01-00020009) , 2) Pressure sensor (code E0…

Company / brand: Bard Peripheral Vascular recalls

Affected product: EnCor EnCompass Breast Biopsy and Tissue Removal System Console (model number recall status

Official ID Z-3275-2026 · Official record ↗

FDA Class II · Medical device · October 7, 2026

Fisher Scientific Sure-Vue Urine hCG recall — Alere San Diego, Inc.

hCG rapid tests may detect low levels of hCG below the stated assay sensitivity, which may result in false positive result.

Company / brand: Alere San Diego recalls

Affected product: Fisher Scientific Sure-Vue Urine hCG recall status

Official ID Z-3274-2026 · Official record ↗

FDA Class II · Medical device · October 7, 2026

Fisher Scientific Sure-Vue Urine hCG Strip recall — Alere San Diego, Inc.

hCG rapid tests may detect low levels of hCG below the stated assay sensitivity, which may result in false positive result.

Company / brand: Alere San Diego recalls

Affected product: Fisher Scientific Sure-Vue Urine hCG Strip recall status

Official ID Z-3273-2026 · Official record ↗

FDA Class II · Medical device · October 7, 2026

Fisher Scientific Sure-Vue Serum/Urine hCG recall — Alere San Diego, Inc.

hCG rapid tests may detect low levels of hCG below the stated assay sensitivity, which may result in false positive result.

Company / brand: Alere San Diego recalls

Affected product: Fisher Scientific Sure-Vue Serum/Urine hCG recall status

Official ID Z-3272-2026 · Official record ↗

FDA Class II · Medical device · October 7, 2026

McKesson CONSULT hCG Urine Cassette recall — Alere San Diego, Inc.

hCG rapid tests may detect low levels of hCG below the stated assay sensitivity, which may result in false positive result.

Company / brand: Alere San Diego recalls

Affected product: McKesson CONSULT hCG Urine Cassette recall status

Official ID Z-3271-2026 · Official record ↗

FDA Class III · Medical device · October 7, 2026

HeartSine samaritan PAD (Public Access Defibrillator) recall — HeartSine Technologies Ltd

Products were distributed without the required Maintenance Supplement, which describes an extra check every 3 months in addition to the monthly check.

Company / brand: HeartSine Technologies recalls

Affected product: HeartSine samaritan PAD (Public Access Defibrillator) recall status

Official ID Z-3270-2026 · Official record ↗

FDA Class I · Medical device · October 7, 2026

VentStar Resus Neo recall — Draeger, Inc.

Potential cracks in the hose, which could lead to leakage or the hose falling off.

Company / brand: Draeger recalls

Affected product: VentStar Resus Neo recall status

Official ID Z-3252-2026 · Official record ↗

FDA Class I · Medical device · October 7, 2026

Medline Basic Homecare Beds and Medlite Homecare Beds and Accessories MDR107000P BED recall — Medline Industries, LP

Potential fire hazard involving the hand control pendant and associated wiring used with affected beds. Pendant or pendant wiring may overheat, potentially leading to smoking, spar…

Company / brand: Medline Industries recalls

Affected product: Medline Basic Homecare Beds and Medlite Homecare Beds and Accessories MDR107000P BED recall status

Official ID Z-3228-2026 · Official record ↗

FDA Class I · Medical device · October 7, 2026

Medline Basic Homecare Beds and Medlite Homecare Beds and Accessories recall — Medline Industries, LP

Potential fire hazard involving the hand control pendant and associated wiring used with affected beds. Pendant or pendant wiring may overheat, potentially leading to smoking, spar…

Company / brand: Medline Industries recalls

Affected product: Medline Basic Homecare Beds and Medlite Homecare Beds and Accessories recall status

Official ID Z-3227-2026 · Official record ↗

FDA Class II · Medical device · October 7, 2026

Philips Medical Systems Technologies Ltd recall — Philips North America Llc

The Bolus tracking scan application may crash with a system error message. Bolus Tracker shots may continue to occur even if the contrast threshold is reached. This may result in t…

Company / brand: Philips North America recalls

Affected product: Philips Medical Systems Technologies Ltd recall status

Official ID Z-3155-2026 · Official record ↗

FDA Class II · Medical device · October 7, 2026

NovaSeq 6000Dx including DRAGEN Server recall — Illumina, Inc.

Retrospectively reported correction for an instrument intended for targeted sequencing of DNA libraries from human genomic DNA used with in vitro diagnostic assays has a server wit…

Company / brand: Illumina recalls

Affected product: NovaSeq 6000Dx including DRAGEN Server recall status

Official ID Z-0068-2027 · Official record ↗

FDA Class II · Medical device · October 7, 2026

Brand Name recall — Custom Interventional Pain Management, LLC

Due to manufacturing issues with the liquid skin adhesive containing in surgical convenience trays/kits.

Company / brand: Custom Interventional Pain Management recalls

Affected product: Brand Name recall status

Official ID Z-0067-2027 · Official record ↗

FDA Class II · Medical device · October 7, 2026

Brand Name recall — ASP Global, LLC.

Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5…

Company / brand: ASP Global recalls

Affected product: Brand Name recall status

Official ID Z-0066-2027 · Official record ↗

FDA Class II · Medical device · October 7, 2026

Brand Name recall — ASP Global, LLC.

Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5…

Company / brand: ASP Global recalls

Affected product: Brand Name recall status

Official ID Z-0065-2027 · Official record ↗

FDA Class II · Medical device · October 7, 2026

Brand Name recall — ASP Global, LLC.

Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5…

Company / brand: ASP Global recalls

Affected product: Brand Name recall status

Official ID Z-0064-2027 · Official record ↗

FDA Class II · Medical device · October 7, 2026

Brand Name recall — ASP Global, LLC.

Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5…

Company / brand: ASP Global recalls

Affected product: Brand Name recall status

Official ID Z-0063-2027 · Official record ↗

FDA Class II · Medical device · October 7, 2026

Brand Name recall — ASP Global, LLC.

Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5…

Company / brand: ASP Global recalls

Affected product: Brand Name recall status

Official ID Z-0062-2027 · Official record ↗

FDA Class II · Medical device · October 7, 2026

Brand Name recall — ASP Global, LLC.

Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5…

Company / brand: ASP Global recalls

Affected product: Brand Name recall status

Official ID Z-0061-2027 · Official record ↗

FDA Class II · Medical device · October 7, 2026

Brand Name recall — ASP Global, LLC.

Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5…

Company / brand: ASP Global recalls

Affected product: Brand Name recall status

Official ID Z-0060-2027 · Official record ↗

FDA Class II · Medical device · October 7, 2026

Brand Name recall — ASP Global, LLC.

Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5…

Company / brand: ASP Global recalls

Affected product: Brand Name recall status

Official ID Z-0059-2027 · Official record ↗

FDA Class II · Medical device · October 7, 2026

Brand Name recall — ASP Global, LLC.

Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5…

Company / brand: ASP Global recalls

Affected product: Brand Name recall status

Official ID Z-0058-2027 · Official record ↗

FDA Class II · Medical device · October 7, 2026

Brand Name recall — ASP Global, LLC.

Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5…

Company / brand: ASP Global recalls

Affected product: Brand Name recall status

Official ID Z-0057-2027 · Official record ↗

FDA Class II · Medical device · October 7, 2026

Brand Name recall — ASP Global, LLC.

Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5…

Company / brand: ASP Global recalls

Affected product: Brand Name recall status

Official ID Z-0056-2027 · Official record ↗

FDA Class II · Medical device · October 7, 2026

Brand Name recall — ASP Global, LLC.

Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5…

Company / brand: ASP Global recalls

Affected product: Brand Name recall status

Official ID Z-0055-2027 · Official record ↗

FDA Class II · Medical device · October 7, 2026

Brand Name recall — ASP Global, LLC.

Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5…

Company / brand: ASP Global recalls

Affected product: Brand Name recall status

Official ID Z-0054-2027 · Official record ↗

FDA Class II · Medical device · October 7, 2026

Brand Name recall — ASP Global, LLC.

Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5…

Company / brand: ASP Global recalls

Affected product: Brand Name recall status

Official ID Z-0053-2027 · Official record ↗

FDA Class II · Medical device · October 7, 2026

Brand Name recall — ASP Global, LLC.

Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5…

Company / brand: ASP Global recalls

Affected product: Brand Name recall status

Official ID Z-0052-2027 · Official record ↗

FDA Class II · Medical device · October 7, 2026

Brand Name recall — ASP Global, LLC.

Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5…

Company / brand: ASP Global recalls

Affected product: Brand Name recall status

Official ID Z-0051-2027 · Official record ↗

FDA Class II · Medical device · October 7, 2026

Brand Name recall — ASP Global, LLC.

Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5…

Company / brand: ASP Global recalls

Affected product: Brand Name recall status

Official ID Z-0050-2027 · Official record ↗

FDA Class II · Medical device · October 7, 2026

Brand Name recall — ASP Global, LLC.

Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5…

Company / brand: ASP Global recalls

Affected product: Brand Name recall status

Official ID Z-0049-2027 · Official record ↗

FDA Class II · Medical device · October 7, 2026

Brand Name recall — ASP Global, LLC.

Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5…

Company / brand: ASP Global recalls

Affected product: Brand Name recall status

Official ID Z-0048-2027 · Official record ↗

FDA Class II · Medical device · October 7, 2026

Brand Name recall — ASP Global, LLC.

Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5…

Company / brand: ASP Global recalls

Affected product: Brand Name recall status

Official ID Z-0047-2027 · Official record ↗

FDA Class II · Medical device · October 7, 2026

Brand Name recall — ASP Global, LLC.

Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5…

Company / brand: ASP Global recalls

Affected product: Brand Name recall status

Official ID Z-0046-2027 · Official record ↗

FDA Class II · Medical device · October 7, 2026

Brand Name recall — ASP Global, LLC.

Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5…

Company / brand: ASP Global recalls

Affected product: Brand Name recall status

Official ID Z-0045-2027 · Official record ↗

FDA Class II · Medical device · October 7, 2026

Brand Name recall — ASP Global, LLC.

Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5…

Company / brand: ASP Global recalls

Affected product: Brand Name recall status

Official ID Z-0044-2027 · Official record ↗

FDA Class II · Medical device · October 7, 2026

Brand Name recall — ASP Global, LLC.

Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5…

Company / brand: ASP Global recalls

Affected product: Brand Name recall status

Official ID Z-0043-2027 · Official record ↗

FDA Class II · Medical device · October 7, 2026

Brand Name recall — ASP Global, LLC.

Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5…

Company / brand: ASP Global recalls

Affected product: Brand Name recall status

Official ID Z-0042-2027 · Official record ↗

FDA Class II · Medical device · October 7, 2026

Brand Name recall — ASP Global, LLC.

Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5…

Company / brand: ASP Global recalls

Affected product: Brand Name recall status

Official ID Z-0041-2027 · Official record ↗

FDA Class II · Medical device · October 7, 2026

Brand Name recall — ASP Global, LLC.

Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5…

Company / brand: ASP Global recalls

Affected product: Brand Name recall status

Official ID Z-0040-2027 · Official record ↗

FDA Class II · Medical device · October 7, 2026

Brand Name recall — ASP Global, LLC.

Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5…

Company / brand: ASP Global recalls

Affected product: Brand Name recall status

Official ID Z-0039-2027 · Official record ↗

FDA Class II · Medical device · October 7, 2026

Brand Name recall — ASP Global, LLC.

Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5…

Company / brand: ASP Global recalls

Affected product: Brand Name recall status

Official ID Z-0038-2027 · Official record ↗

FDA Class II · Medical device · October 7, 2026

Brand Name recall — ASP Global, LLC.

Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5…

Company / brand: ASP Global recalls

Affected product: Brand Name recall status

Official ID Z-0037-2027 · Official record ↗

FDA Class II · Medical device · October 7, 2026

Brand Name recall — ASP Global, LLC.

Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5…

Company / brand: ASP Global recalls

Affected product: Brand Name recall status

Official ID Z-0036-2027 · Official record ↗

FDA Class II · Medical device · October 7, 2026

Brand Name recall — ASP Global, LLC.

Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5…

Company / brand: ASP Global recalls

Affected product: Brand Name recall status

Official ID Z-0035-2027 · Official record ↗

FDA Class II · Medical device · October 7, 2026

Brand Name recall — ASP Global, LLC.

Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5…

Company / brand: ASP Global recalls

Affected product: Brand Name recall status

Official ID Z-0034-2027 · Official record ↗

FDA Class II · Medical device · October 7, 2026

Brand Name recall — ASP Global, LLC.

Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5…

Company / brand: ASP Global recalls

Affected product: Brand Name recall status

Official ID Z-0033-2027 · Official record ↗

FDA Class II · Medical device · October 7, 2026

Brand Name recall — ASP Global, LLC.

Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5…

Company / brand: ASP Global recalls

Affected product: Brand Name recall status

Official ID Z-0032-2027 · Official record ↗

FDA Class II · Medical device · October 7, 2026

Brand Name recall — ASP Global, LLC.

Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5…

Company / brand: ASP Global recalls

Affected product: Brand Name recall status

Official ID Z-0031-2027 · Official record ↗

FDA Class II · Medical device · October 7, 2026

Brand Name recall — ASP Global, LLC.

Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5…

Company / brand: ASP Global recalls

Affected product: Brand Name recall status

Official ID Z-0030-2027 · Official record ↗

FDA Class II · Medical device · October 7, 2026

Brand Name recall — ASP Global, LLC.

Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5…

Company / brand: ASP Global recalls

Affected product: Brand Name recall status

Official ID Z-0029-2027 · Official record ↗

FDA Class II · Medical device · October 7, 2026

Brand Name recall — ASP Global, LLC.

Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5…

Company / brand: ASP Global recalls

Affected product: Brand Name recall status

Official ID Z-0028-2027 · Official record ↗

FDA Class II · Medical device · October 7, 2026

Brand Name recall — ASP Global, LLC.

Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5…

Company / brand: ASP Global recalls

Affected product: Brand Name recall status

Official ID Z-0027-2027 · Official record ↗

FDA Class II · Medical device · October 7, 2026

Brand Name recall — ASP Global, LLC.

Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5…

Company / brand: ASP Global recalls

Affected product: Brand Name recall status

Official ID Z-0026-2027 · Official record ↗

FDA Class II · Medical device · October 7, 2026

Brand Name recall — ASP Global, LLC.

Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5…

Company / brand: ASP Global recalls

Affected product: Brand Name recall status

Official ID Z-0025-2027 · Official record ↗

FDA Class II · Medical device · October 7, 2026

Brand Name recall — ASP Global, LLC.

Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5…

Company / brand: ASP Global recalls

Affected product: Brand Name recall status

Official ID Z-0024-2027 · Official record ↗

FDA Class II · Medical device · October 7, 2026

Brand Name recall — ASP Global, LLC.

Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5…

Company / brand: ASP Global recalls

Affected product: Brand Name recall status

Official ID Z-0023-2027 · Official record ↗

FDA Class II · Medical device · October 7, 2026

Brand Name recall — ASP Global, LLC.

Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5…

Company / brand: ASP Global recalls

Affected product: Brand Name recall status

Official ID Z-0022-2027 · Official record ↗

FDA Class II · Medical device · October 7, 2026

Brand Name recall — ASP Global, LLC.

Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5…

Company / brand: ASP Global recalls

Affected product: Brand Name recall status

Official ID Z-0021-2027 · Official record ↗

FDA Class II · Medical device · October 7, 2026

Brand Name recall — ASP Global, LLC.

Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5…

Company / brand: ASP Global recalls

Affected product: Brand Name recall status

Official ID Z-0020-2027 · Official record ↗

FDA Class II · Medical device · October 7, 2026

Brand Name recall — ASP Global, LLC.

Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5…

Company / brand: ASP Global recalls

Affected product: Brand Name recall status

Official ID Z-0019-2027 · Official record ↗

FDA Class II · Medical device · October 7, 2026

Brand Name recall — ASP Global, LLC.

Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5…

Company / brand: ASP Global recalls

Affected product: Brand Name recall status

Official ID Z-0018-2027 · Official record ↗

FDA Class II · Medical device · October 7, 2026

Brand Name recall — ASP Global, LLC.

Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5…

Company / brand: ASP Global recalls

Affected product: Brand Name recall status

Official ID Z-0017-2027 · Official record ↗

FDA Class II · Medical device · October 7, 2026

Brand Name recall — ASP Global, LLC.

Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5…

Company / brand: ASP Global recalls

Affected product: Brand Name recall status

Official ID Z-0016-2027 · Official record ↗

FDA Class II · Medical device · October 7, 2026

Brand Name recall — ASP Global, LLC.

Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5…

Company / brand: ASP Global recalls

Affected product: Brand Name recall status

Official ID Z-0015-2027 · Official record ↗

FDA Class II · Medical device · October 7, 2026

Brand Name recall — ASP Global, LLC.

Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5…

Company / brand: ASP Global recalls

Affected product: Brand Name recall status

Official ID Z-0014-2027 · Official record ↗

FDA Class II · Medical device · October 7, 2026

Brand Name recall — ASP Global, LLC.

Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5…

Company / brand: ASP Global recalls

Affected product: Brand Name recall status

Official ID Z-0013-2027 · Official record ↗

FDA Class II · Medical device · October 7, 2026

Brand Name recall — ASP Global, LLC.

Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5…

Company / brand: ASP Global recalls

Affected product: Brand Name recall status

Official ID Z-0012-2027 · Official record ↗

FDA Class II · Medical device · October 7, 2026

Brand Name recall — ASP Global, LLC.

Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5…

Company / brand: ASP Global recalls

Affected product: Brand Name recall status

Official ID Z-0011-2027 · Official record ↗

FDA Class II · Medical device · October 7, 2026

Brand Name recall — ASP Global, LLC.

Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5…

Company / brand: ASP Global recalls

Affected product: Brand Name recall status

Official ID Z-0010-2027 · Official record ↗

FDA Class II · Medical device · October 7, 2026

Brand Name recall — ASP Global, LLC.

Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5…

Company / brand: ASP Global recalls

Affected product: Brand Name recall status

Official ID Z-0009-2027 · Official record ↗

FDA Class II · Medical device · October 7, 2026

Brand Name recall — ASP Global, LLC.

Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5…

Company / brand: ASP Global recalls

Affected product: Brand Name recall status

Official ID Z-0008-2027 · Official record ↗

FDA Class II · Medical device · October 7, 2026

Brand Name recall — ASP Global, LLC.

Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5…

Company / brand: ASP Global recalls

Affected product: Brand Name recall status

Official ID Z-0007-2027 · Official record ↗

FDA Class II · Medical device · October 7, 2026

Brand Name recall — ASP Global, LLC.

Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5…

Company / brand: ASP Global recalls

Affected product: Brand Name recall status

Official ID Z-0006-2027 · Official record ↗

FDA Class II · Medical device · October 7, 2026

Brand Name recall — ASP Global, LLC.

Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5…

Company / brand: ASP Global recalls

Affected product: Brand Name recall status

Official ID Z-0005-2027 · Official record ↗

FDA Class II · Medical device · October 7, 2026

Brand Name recall — ASP Global, LLC.

Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5…

Company / brand: ASP Global recalls

Affected product: Brand Name recall status

Official ID Z-0004-2027 · Official record ↗

FDA Class II · Medical device · October 7, 2026

Brand Name recall — ASP Global, LLC.

Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5…

Company / brand: ASP Global recalls

Affected product: Brand Name recall status

Official ID Z-0003-2027 · Official record ↗

FDA Class II · Medical device · September 30, 2026

Medline Convenience Kits recall — Medline Industries, LP

The kits contain neurological sponges with the potential for unexpected variability of endotoxin levels. Potentially elevated endotoxin levels may present health risks that could r…

Company / brand: Medline Industries recalls

Affected product: Medline Convenience Kits recall status

Official ID Z-3269-2026 · Official record ↗

FDA Class II · Medical device · September 30, 2026

Medline Convenience Kits recall — Medline Industries, LP

The kits contain neurological sponges with the potential for unexpected variability of endotoxin levels. Potentially elevated endotoxin levels may present health risks that could r…

Company / brand: Medline Industries recalls

Affected product: Medline Convenience Kits recall status

Official ID Z-3268-2026 · Official record ↗

FDA Class II · Medical device · September 30, 2026

Medline Convenience Kits recall — Medline Industries, LP

The kits contain neurological sponges with the potential for unexpected variability of endotoxin levels. Potentially elevated endotoxin levels may present health risks that could r…

Company / brand: Medline Industries recalls

Affected product: Medline Convenience Kits recall status

Official ID Z-3267-2026 · Official record ↗

FDA Class II · Medical device · September 30, 2026

Medline Convenience Kits recall — Medline Industries, LP

The kits contain neurological sponges with the potential for unexpected variability of endotoxin levels. Potentially elevated endotoxin levels may present health risks that could r…

Company / brand: Medline Industries recalls

Affected product: Medline Convenience Kits recall status

Official ID Z-3266-2026 · Official record ↗

FDA Class II · Medical device · September 30, 2026

Medline Convenience Kits recall — Medline Industries, LP

The kits contain neurological sponges with the potential for unexpected variability of endotoxin levels. Potentially elevated endotoxin levels may present health risks that could r…

Company / brand: Medline Industries recalls

Affected product: Medline Convenience Kits recall status

Official ID Z-3265-2026 · Official record ↗

FDA Class II · Medical device · September 30, 2026

PRO+ 40" MRS SURFACE recall — Baxter Healthcare Corporation

There is an error in the product description on the Unique Device Identification (UDI) label. These discrepancies in labeling do not align with the approved product or product spec…

Company / brand: Baxter Healthcare recalls

Affected product: PRO+ 40" MRS SURFACE recall status

Official ID Z-3264-2026 · Official record ↗

FDA Class II · Medical device · September 30, 2026

PRO+ 36" MRS SURFACE recall — Baxter Healthcare Corporation

There is an error in the product description on the Unique Device Identification (UDI) label. These discrepancies in labeling do not align with the approved product or product spec…

Company / brand: Baxter Healthcare recalls

Affected product: PRO+ 36" MRS SURFACE recall status

Official ID Z-3263-2026 · Official record ↗

FDA Class II · Medical device · September 30, 2026

PRO+ MRS SURFACE FOR VERSACARE recall — Baxter Healthcare Corporation

There is an error in the product description on the Unique Device Identification (UDI) label. These discrepancies in labeling do not align with the approved product or product spec…

Company / brand: Baxter Healthcare recalls

Affected product: PRO+ MRS SURFACE FOR VERSACARE recall status

Official ID Z-3262-2026 · Official record ↗

FDA Class II · Medical device · September 30, 2026

Halyard IV START KIT NON-STERILE recall — AVID Medical, Inc.

Convenience kits containing BD ChloraPrep Clear - 1 mL Applicator, which may exhibit an open or incomplete seal on the packaging of the applicator.

Company / brand: AVID Medical recalls

Affected product: Halyard IV START KIT NON-STERILE recall status

Official ID Z-3261-2026 · Official record ↗

FDA Class II · Medical device · September 30, 2026

Halyard IV START KIT NON-STERILE recall — AVID Medical, Inc.

Convenience kits containing BD ChloraPrep Clear - 1 mL Applicator, which may exhibit an open or incomplete seal on the packaging of the applicator.

Company / brand: AVID Medical recalls

Affected product: Halyard IV START KIT NON-STERILE recall status

Official ID Z-3260-2026 · Official record ↗

FDA Class II · Medical device · September 30, 2026

New York Embroidery Studio Trinity Non-Surgical Isolation Gown recall — New York Embroidery Studio, Inc.

Gowns do not consistently meet the minimum liquid-barrier performance required.

Company / brand: New York Embroidery Studio recalls

Affected product: New York Embroidery Studio Trinity Non-Surgical Isolation Gown recall status

Official ID Z-3259-2026 · Official record ↗

FDA Class II · Medical device · September 30, 2026

Cardioroot Woven Collagen Coated Vascular Graft recall — INTERVASCULAR, SAS

Product failed to meet the specified acceptance criteria for Integral Water Permeability (IWP).

Company / brand: INTERVASCULAR recalls

Affected product: Cardioroot Woven Collagen Coated Vascular Graft recall status

Official ID Z-3258-2026 · Official record ↗

FDA Class II · Medical device · September 30, 2026

Brand Name recall — Baxter Healthcare Corporation

Contamination within the release test equipment flow path could have affected the accuracy of the nebulizer flow rate. Affected devices returned to firm and testing confirmed devic…

Company / brand: Baxter Healthcare recalls

Affected product: Brand Name recall status

Official ID Z-3257-2026 · Official record ↗

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