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.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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.