Browse Device Recalls

5,321 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 5,321 FDA medical device recall enforcement actions. Each entry includes the device description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.

Medical Device Recalls

Browse 5,321 FDA device recalls.

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DateProductReasonClassFirm
May 17, 2024 The VASOVIEW HemoPro 2 Endoscopic Vessel Harvesting System, labeled as the fo... Potential for there to be a fluid ingress into the handle of the harvesting tool, which may lead ... Class II Maquet Cardiovascular, LLC
May 16, 2024 Proclaim 5 Elite Implantable Pulse Generator, REF 3660, Sterile EO, Rx Only The duration between the implantable pulse generator reaching the elective replacement indicator... Class II Abbott Medical
May 16, 2024 Abbott Proclaim 7 Implantable Pulse Generator, REF 3663, Sterile EO, Rx Only The duration between the implantable pulse generator reaching the elective replacement indicator... Class II Abbott Medical
May 16, 2024 Proclaim 7 Elite Implantable Pulse Generator, REF 3662, Sterile EO, Rx Only The duration between the implantable pulse generator reaching the elective replacement indicator... Class II Abbott Medical
May 16, 2024 Abbott Proclaim 5 Implantable Pulse Generator, REF 3665, Sterile EO, Rx Only The duration between the implantable pulse generator reaching the elective replacement indicator... Class II Abbott Medical
May 16, 2024 Abbott Proclaim Plus 5 Implantable Pulse Generator, REF 3671, Sterile EO, Rx ... The duration between the implantable pulse generator reaching the elective replacement indicator... Class II Abbott Medical
May 16, 2024 Abbott Proclaim DRG Implantable Pulse Generator, REF 3664, Sterile EO, Rx Only The duration between the implantable pulse generator reaching the elective replacement indicator... Class II Abbott Medical
May 16, 2024 Abbott Proclaim Plus 5 Implantable Pulse Generator, REF 3670, Sterile EO, Rx ... The duration between the implantable pulse generator reaching the elective replacement indicator... Class II Abbott Medical
May 16, 2024 Abbott Proclaim Plus 7 Implantable Pulse Generator, REF 3672, Sterile EO, Rx ... The duration between the implantable pulse generator reaching the elective replacement indicator... Class II Abbott Medical
May 16, 2024 Abbott Proclaim XR 7 Implantable Pulse Generator, REF 3662, Sterile EO, Rx Only The duration between the implantable pulse generator reaching the elective replacement indicator... Class II Abbott Medical
May 16, 2024 Abbott Proclaim 7 Implantable Pulse Generator, REF 3667, Sterile EO, Rx Only The duration between the implantable pulse generator reaching the elective replacement indicator... Class II Abbott Medical
May 16, 2024 Abbott Proclaim 5 Implantable Pulse Generator, REF 3661, Sterile EO, Rx Only The duration between the implantable pulse generator reaching the elective replacement indicator... Class II Abbott Medical
May 16, 2024 Abbott Proclaim XR 5 Implantable Pulse Generator, REF 3660, Sterile EO, Rx Only The duration between the implantable pulse generator reaching the elective replacement indicator... Class II Abbott Medical
May 15, 2024 Ultrathane Cook-Cope Type Locking Loop Multipurpose Drainage Catheter-ULT12.0... Product labels state the incorrect expiration dates that extends beyond their true expiration date Class II Cook Incorporated
May 15, 2024 Ultrathane Mac-Loc Locking Loop Multipurpose Drainage Catheter ULT16.0-38-25-... Product labels state the incorrect expiration dates that extends beyond their true expiration date Class II Cook Incorporated
May 14, 2024 AMT Initial Placement Dilator Set. Used to place gastrostomy devices. Devices were labelled with the incorrect guidewire labelling. Class II Applied Medical Technology Inc
May 13, 2024 Darby Prophylaxis Paste with 1.23% Fluoride Ion, Mint Coarse Part number 040032, Lot number, 248607 was incorrectly labeled as part number 045032 Class II Young Dental Manufacturing I, LLC
May 13, 2024 Non-sterile, single use, disposable gloves intended for medical purposes to b... Firm received complaints regarding skin irritation when using the gloves, disintegration of the g... Class II SVS LLC
May 9, 2024 Syringe Tip Caps labeled as: 1) SOL-M Syringe Tip Cap, Blue, Model No. STC... Products in distribution were found by FDA to be to be substantially different from the current c... Class II Sol-Millennium Medical Inc.
May 9, 2024 Syringes with Fixed Needles labeled as: a) SOL-M: 1) SOL-M 1ml TB Syring... Products in distribution were found by FDA to be to be substantially different from the current c... Class II Sol-Millennium Medical Inc.
May 9, 2024 Syringes with exchangeable needles labeled as: SOL-CARE: 1) SOL-CARE 1... Products in distribution were found by FDA to be to be substantially different from the current c... Class II Sol-Millennium Medical Inc.
May 9, 2024 Syringes with Low Dead Space labeled as: a) SOL-M 1ml Slip Tip Syringe w/o... Products in distribution were found by FDA to be to be substantially different from the current c... Class II Sol-Millennium Medical Inc.
May 9, 2024 Syringes with Luer Slip Tips labeled as: 1) SOL-M 1ml Slip Tip Syringe w/o... Products in distribution were found by FDA to be to be substantially different from the current c... Class II Sol-Millennium Medical Inc.
May 9, 2024 Syringes with Eccentric Tips labeled as: 1) SOL-M 10ml Eccentric Tip Syrin... Products in distribution were found by FDA to be to be substantially different from the current c... Class II Sol-Millennium Medical Inc.
Apr 24, 2024 smith&nephew OXINIUM Femoral Head 12/14 Taper, REF 71343204, 32 MM OD +4, Ste... Packaging contained the incorrect size of femoral head from what was displayed on the label. Class II Smith & Nephew Inc
Apr 22, 2024 Independent Medical Co-op Inc., Streptococcal A rapid test kits, labeled as: ... Wondfo USA has identified unauthorized distribution of the Preview Strep A Test Kit. Unauthorized... Class II Wondfo USA Co Ltd
Apr 22, 2024 Streptococcal A rapid test kits, labeled as: Wondfo Biotech Co., Ltd, WondVi... Wondfo USA has identified unauthorized distribution of the Preview Strep A Test Kit. Unauthorized... Class II Wondfo USA Co Ltd
Apr 22, 2024 Streptococcal A rapid test kits, labeled as: Easy Healthcare Corporation, Ar... Wondfo USA has identified unauthorized distribution of the Preview Strep A Test Kit. Unauthorized... Class II Wondfo USA Co Ltd
Apr 22, 2024 Clarity and Clarity Diagnostics LLC, Streptococcal A rapid test kits, Labeled... Wondfo USA has identified unauthorized distribution of the Preview Strep A Test Kit. Unauthorized... Class II Wondfo USA Co Ltd
Apr 17, 2024 Yamaha Surface Mounter YR series, YS series, i-Pulse series, Sigma series, S ... Non-medical laser products which were determined to not be in compliance with 21 C.F.R. ¿ 1010.2 ... Class II YAMAHA MOTOR CORPORATION
Apr 17, 2024 Optical Inspection System, YSi series, YRi series. Affected models: YSi-V, YS... Non-medical laser products which were determined to not be in compliance with 21 C.F.R. ¿ 1010.2 ... Class II YAMAHA MOTOR CORPORATION
Apr 17, 2024 Syringes labeled as: a) SYR 10ML L/L CONTROL, Item Numbers: 1. DNSC91881,... These syringes were identified to be affected by the FDA Safety Alert issued on March 19, 2024. L... Class II MEDLINE INDUSTRIES, LP - Northfield
Apr 10, 2024 9006767 Astra EV 4.8mm Milled Titanium Abutment Milled abutments are too b... Due to incorrect milled titanium abutment being packaged and labeled. Class II Preat Corp
Apr 8, 2024 Medline procedure packs containing Shenli syringes, labeled as follows: NE... Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... Class II MEDLINE INDUSTRIES, LP - Northfield
Apr 8, 2024 Medline Convenience kits, labeled as: 1) DYNJ39451D , Pack Number HOOD PAC... Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... Class II MEDLINE INDUSTRIES, LP - Northfield
Apr 8, 2024 Medline Convenience kits, labeled as: aa1) BURN PACK-LF, Pack Number DYNJ... Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... Class II MEDLINE INDUSTRIES, LP - Northfield
Apr 8, 2024 Medline Convenience kits labeled as: 1) GER ARTH BASIN PK RFID-LF , Pack Nu... Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... Class II MEDLINE INDUSTRIES, LP - Northfield
Apr 8, 2024 Centurion procedure kits, labeled as: 1) ARTHROGRAM TRAY, Pack Number DYND... Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... Class II MEDLINE INDUSTRIES, LP - Northfield
Apr 8, 2024 Medline Convenience kits labeled as: 1) C-SECTION TRAY, Pack Number AM160B ... Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... Class II MEDLINE INDUSTRIES, LP - Northfield
Apr 8, 2024 Medline Convenience kits labeled as: 1) URETEROSCOPY CDS SC-LF, Pack Numbe... Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... Class II MEDLINE INDUSTRIES, LP - Northfield
Apr 8, 2024 Medline Convenience kits labeled as: KIT,ER SUTURE #1, Pack Number DYNDS1... Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... Class II MEDLINE INDUSTRIES, LP - Northfield
Apr 8, 2024 Medline Convenience kits labeled as: 1) KIT GENERAL CLOSURE , Pack Number ... Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... Class II MEDLINE INDUSTRIES, LP - Northfield
Apr 8, 2024 Medline procedural kits labeled as: UMBILICAL LINE KIT W/FOAM, Pack Number... Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... Class II MEDLINE INDUSTRIES, LP - Northfield
Apr 8, 2024 Medline procedural kits labeled as: 1) SR C SECTION, Pack Number DYNJ908584;... Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... Class II MEDLINE INDUSTRIES, LP - Northfield
Apr 8, 2024 Medline Convenience kits labeled as: PARACERVICAL PUDENDAL BLOCK TR, Pack ... Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... Class II MEDLINE INDUSTRIES, LP - Northfield
Apr 8, 2024 Medline Convenience kits labeled as: 1) ARTHROGRAPHY DRAPE PACK , Pack Numb... Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... Class II MEDLINE INDUSTRIES, LP - Northfield
Apr 8, 2024 Medline Convenience kits labeled as: 1) FETOSCOPY CDS-LF, Pack Number CDS8... Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... Class II MEDLINE INDUSTRIES, LP - Northfield
Apr 8, 2024 Medline Convenience kits labeled as: 1) DIALYSIS CATH ACCESS KIT, Pack Num... Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... Class II MEDLINE INDUSTRIES, LP - Northfield
Apr 8, 2024 Medline Convenience kits labeled as: 1) LAVH CDS, Pack Number CDS760049AB; ... Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... Class II MEDLINE INDUSTRIES, LP - Northfield
Apr 8, 2024 Centurion procedure packs, containing Caina syringes, labeled as: 1) CIRC... Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... Class II MEDLINE INDUSTRIES, LP - Northfield

Frequently Asked Questions

When a device safety issue is identified, the manufacturer or FDA initiates a recall. The FDA publishes an enforcement report detailing the device, the reason for the recall, and distribution. Healthcare facilities and providers are notified to check their inventory and take corrective action.

All types — from simple devices like blood glucose test strips and surgical gloves to complex devices like pacemakers, defibrillators, insulin pumps, hip implants, and ventilators. Software-driven devices are increasingly common in recalls due to bugs and cybersecurity vulnerabilities.

Use the search and filter tools on this page. Each recall entry includes the device description, model numbers, and distribution details so you can determine if your device is affected. Contact your healthcare provider if you find a match.