Browse Device Recalls

2,447 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,447 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 2,447 FDA device recalls.

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DateProductReasonClassFirm
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 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 Procedure kits labeled as: 1) CIRCUMCISION SET, Pack Number CIT633... 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) PRESSURE TUBING B.I., Pack Number 8... 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) MYELOGRAM PACK, Pack Number 00-3990... 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) BIOPSY PROCEDURE PACK, 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) INFECTION DRIVELINE MANAGEMENT KIT... 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) BLOOD CULTURE COLLECTION KIT, 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 procedural kits labeled as: 1) DRAWER 3 LAB DRAW & IV START, 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 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 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 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) 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 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 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 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 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) ARTHROGRAM TRAY, Pack Number MNS119... 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) ARTHRO... Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... Class II MEDLINE INDUSTRIES, LP - Northfield
Mar 22, 2024 Medline medical procedure kits labeled as follows: a) ARTHROSCOPY, REF DYN... A slight dimensional variation which has the potential for increased difficulty fitting into oute... Class II MEDLINE INDUSTRIES, LP - Northfield
Mar 22, 2024 Medline medical procedure kits labeled as follows: a) MAJOR BREAST, REF DY... A slight dimensional variation which has the potential for increased difficulty fitting into oute... Class II MEDLINE INDUSTRIES, LP - Northfield
Mar 22, 2024 Medline medical procedure kits labeled as follows: a) C-SECTION CDS, REF C... A slight dimensional variation which has the potential for increased difficulty fitting into oute... Class II MEDLINE INDUSTRIES, LP - Northfield
Mar 22, 2024 Medline medical procedure kits labeled as follows: a) ENDO KIT, REF DYK101... A slight dimensional variation which has the potential for increased difficulty fitting into oute... Class II MEDLINE INDUSTRIES, LP - Northfield
Mar 22, 2024 1,5L MED-SOFT LINER W/ 6MMX3M TUB. & ADULT VC, REF OR53929 A slight dimensional variation which has the potential for increased difficulty fitting into oute... Class II MEDLINE INDUSTRIES, LP - Northfield
Mar 22, 2024 Medline medical procedure kits labeled as follows: a) GYN CDS, REF DYNJ905... A slight dimensional variation which has the potential for increased difficulty fitting into oute... Class II MEDLINE INDUSTRIES, LP - Northfield
Mar 22, 2024 Medline medical procedure kits labeled as follows: a) ANESTHESIA CIRCUIT A... A slight dimensional variation which has the potential for increased difficulty fitting into oute... Class II MEDLINE INDUSTRIES, LP - Northfield
Mar 22, 2024 Medline medical procedure kits labeled as follows: a) BASIC NEURO, REF DYN... A slight dimensional variation which has the potential for increased difficulty fitting into oute... Class II MEDLINE INDUSTRIES, LP - Northfield
Mar 22, 2024 Medline medical procedure kits labeled as follows: a) ENDO KIT, REF DYKE1410A A slight dimensional variation which has the potential for increased difficulty fitting into oute... Class II MEDLINE INDUSTRIES, LP - Northfield
Mar 22, 2024 1500ML SOFT LINER, 1/4X6 TBG NS, REF OR926K A slight dimensional variation which has the potential for increased difficulty fitting into oute... Class II MEDLINE INDUSTRIES, LP - Northfield
Mar 22, 2024 Medline medical procedure kits labeled as follows: DENTAL, REF DYNJ909211A A slight dimensional variation which has the potential for increased difficulty fitting into oute... Class II MEDLINE INDUSTRIES, LP - Northfield
Mar 22, 2024 Medline medical procedure kits labeled as follows: a) KIT CANISTER SUCT W ... A slight dimensional variation which has the potential for increased difficulty fitting into oute... Class II MEDLINE INDUSTRIES, LP - Northfield
Mar 22, 2024 1,5L MED-SOFT LINER W/ 6MMX1,8M TUB. & ADULT VC, REF OR53926 A slight dimensional variation which has the potential for increased difficulty fitting into oute... Class II MEDLINE INDUSTRIES, LP - Northfield
Mar 22, 2024 Medline medical procedure kits labeled as follows: a) TURNOVER KIT, REF DY... A slight dimensional variation which has the potential for increased difficulty fitting into oute... Class II MEDLINE INDUSTRIES, LP - Northfield
Mar 22, 2024 Medline medical procedure kits labeled as follows: a) AAA CDS, REF CDS9840... A slight dimensional variation which has the potential for increased difficulty fitting into oute... Class II MEDLINE INDUSTRIES, LP - Northfield
Mar 22, 2024 1,5L MED-SOFT SINGLE LINER WITH SOLIDIFIER, REF OR1920PG A slight dimensional variation which has the potential for increased difficulty fitting into oute... Class II MEDLINE INDUSTRIES, LP - Northfield
Mar 22, 2024 Medline medical procedure kits labeled as follows: a) BASIC NASAL, REF D... A slight dimensional variation which has the potential for increased difficulty fitting into oute... Class II MEDLINE INDUSTRIES, LP - Northfield
Mar 22, 2024 Medline medical procedure kits labeled as follows: a) CYSTO, REF DYNJ90500... A slight dimensional variation which has the potential for increased difficulty fitting into oute... Class II MEDLINE INDUSTRIES, LP - Northfield
Mar 22, 2024 LINER, SOFT, SUCTION CANISTER, 1500CC, REF OR929K A slight dimensional variation which has the potential for increased difficulty fitting into oute... Class II MEDLINE INDUSTRIES, LP - Northfield
Mar 22, 2024 Medline medical procedure kits labeled as follows: a) HEART ANESTHESIA SET... A slight dimensional variation which has the potential for increased difficulty fitting into oute... Class II MEDLINE INDUSTRIES, LP - Northfield
Mar 22, 2024 LINER, SOFT, SUCTION CANISTER, 1500CC, REF DYNDSCL1500 A slight dimensional variation which has the potential for increased difficulty fitting into oute... Class II MEDLINE INDUSTRIES, LP - Northfield
Mar 20, 2024 ZPLP (Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate... Thread form issue for the locking holes in that the locking screws may not properly mate with the... Class II Zimmer, Inc.
Mar 20, 2024 ZPLP (Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate... Thread form issue for the locking holes in that the locking screws may not properly mate with the... Class II Zimmer, Inc.
Mar 20, 2024 ZPLP (Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plat... Thread form issue for the locking holes in that the locking screws may not properly mate with the... Class II Zimmer, Inc.
Mar 20, 2024 ZPLP(Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate... Thread form issue for the locking holes in that the locking screws may not properly mate with the... Class II Zimmer, Inc.
Mar 20, 2024 ZPLP (Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate... Thread form issue for the locking holes in that the locking screws may not properly mate with the... Class II Zimmer, Inc.
Mar 20, 2024 ZPLP (Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plat... Thread form issue for the locking holes in that the locking screws may not properly mate with the... Class II Zimmer, Inc.
Mar 20, 2024 ZPLP (Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate... Thread form issue for the locking holes in that the locking screws may not properly mate with the... Class II Zimmer, Inc.
Mar 20, 2024 ZPLP (Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate... Thread form issue for the locking holes in that the locking screws may not properly mate with the... Class II Zimmer, Inc.
Mar 20, 2024 ZPLP (Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate... Thread form issue for the locking holes in that the locking screws may not properly mate with the... Class II Zimmer, Inc.

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.