Browse Device Recalls

3,276 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,276 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 3,276 FDA device recalls in 2024.

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DateProductReasonClassFirm
Apr 8, 2024 Medline Convenience kits, containing Shenli syringes, labeled as: 1) LOCAL... 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 CATHETER INSERTION KIT, P... 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: TONSIL & ADENOID PACK, Pack Number DY... 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) CIRCUMCISION TRAY, Pack Number CIT6... 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) CIRCUMCISION TRAY, Pack Number CIT67... 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) BIOPSY KIT, Pack Number DYNDA1466A... 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: SCS-LF, DYNJ902314D 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) AFCH ANTERIOR SEGMENT PK, 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: GAMMA NAIL CDS-LF , Pack Number CD... 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) 6" FEMORAL ARTERIAL LINE KIT- ICU,... 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) ARTH... 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: MUNCY PACK, Pack Number DYNJ03097D 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) ALL DOC EYE PACK, Pack Number DYNJ51... 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: NEURO TRAY, Pack Number DYNJ55909B 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 VASCULAR IVC FILTER PLACEM, 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) CHEST TUBE INSERTION TRAY, 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) CVC INSERT BUNDLE 16CM, 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 Centurion procedure kits, labeled as: 1) 6" FEMORAL ARTERIAL LINE KIT- ICU... 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) TYMPANOPLASTY , Pack Number CDS9802... 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) MEDICAL CIRCUMCISION TRAY, 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: ADMIT KIT PILLOW BOX, Pack Number DYK... 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: HSG TRAY, Pack Number DYNDH1453 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) PSP - VAMC LONG BEACH, 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 Convenience kits labeled as: 1) OR CLEAN UP KIT, Pack Number DYK10... 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) BREA... 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 procedure packs containing Shenli syringes, labeled as follows: 1)... 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) BONE MARROW TRAY, Pack Number SPEC... 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) EP DRAPE 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 Centurion procedure packs, labeled as: 1) BIOPSY TRAY-LF, Pack Number SPEC... 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) CVC INSERTION PACK, Pack Number CV... 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) TRACHEOTOMY TRAY, Pack Number DYN... 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) ARTH... Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... Class II MEDLINE INDUSTRIES, LP - Northfield
Apr 8, 2024 Vyaire Medical GmbH, Vyaire Twin Tube sample line 240 cm, Model Number V-7073... Potential of the nozzle separating during patient use. Class I Vyaire Medical, Inc.
Apr 8, 2024 Medline Convenience kits labeled as: 1) CYSTO PACK, Pack Number DYNJ42742D... 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) NHP BREAST BIOPSY PACK, 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 HeartSine samaritan PAD (Public Access Defibrillator), Type: SAM 350P, SAM 36... Automated external defibrillators have a manufacturing issue that could prevent the device from d... Class II HeartSine Technologies Ltd
Apr 8, 2024 Medline Convenience kits labeled as: 1) STEREOTACTIC BREAST BIOPSY TRA, Pa... 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) UROLOGY MINOR CDS , Pack Number CD... 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) CENTRAL LINE CDS, Pack Number CDS93... 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) NICU ... 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 procedure packs containing Shenli syringes, labeled as follows: 1)... 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: PREOP NERVE BLOCK TRAY, Pack Number DY... 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) ADMIT KIT , Pack Number DYKA1225B;... Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... Class II MEDLINE INDUSTRIES, LP - Northfield
Apr 8, 2024 Novalung sensor box is a component of the Novalung Console (F30000162)-Indica... Issue related to Novalung sensor box, which is a component of the Novalung Console (Part Number F... Class II Fresenius Medical Care Holdings, Inc.
Apr 8, 2024 Medline procedure kits labeled as: 1) NEPHROLOGY PACK, Pack Number DYNJ590... Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... Class I MEDLINE INDUSTRIES, LP - Northfield
Apr 8, 2024 Centurion procedure kits labeled as: 1) 3" RADIAL ARTERIAL LINE KIT- ICU, P... 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) OPEN HEART PEDS, Pack Number CDS981... 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 MANIFOLD CSTM-NORTHRIDGE, 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 procedure packs containing Shenli syringes, labeled as follows: 1) D... 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) SUTURING SET PACK ASSY P791011, ... 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.