Browse Device Recalls

960 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 960 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 960 FDA device recalls.

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DateProductReasonClassFirm
Nov 21, 2024 Medline custom medical procedure kits labeled as: 1) FREE FLAP BASIC SET-U... Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties ... Class II MEDLINE INDUSTRIES, LP - Northfield
Nov 21, 2024 Medline custom medical procedure kits labeled as: 1) ENDOSCOPIC SKULL BASE... Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties ... Class II MEDLINE INDUSTRIES, LP - Northfield
Nov 21, 2024 Medline custom medical procedure kits labeled as: 1) NEURO BASIN PACK-LF, ... Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties ... Class II MEDLINE INDUSTRIES, LP - Northfield
Nov 21, 2024 Medline custom medical procedure kits labeled as: 1) NASAL PACK, REF DYNJ6... Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties ... Class II MEDLINE INDUSTRIES, LP - Northfield
Nov 21, 2024 Medline custom medical procedure kits labeled as: 1) MICRODISECTOMY PACK, ... Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties ... Class II MEDLINE INDUSTRIES, LP - Northfield
Nov 21, 2024 Medline custom medical procedure kits labeled as: 1) MEM MAXILLOFACIAL PAC... Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties ... Class II MEDLINE INDUSTRIES, LP - Northfield
Nov 21, 2024 Medline custom medical procedure kits labeled as: 1) CATH LAB PACK-LF, REF... Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties ... Class II MEDLINE INDUSTRIES, LP - Northfield
Nov 21, 2024 Medline custom medical procedure kits labeled as: 1) VP SHUNT CDS, REF CDS... Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties ... Class II MEDLINE INDUSTRIES, LP - Northfield
Nov 21, 2024 Medline custom medical procedure kits labeled as: DEEP BRAIN STIMULATION P... Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties ... Class II MEDLINE INDUSTRIES, LP - Northfield
Nov 21, 2024 See DocMan Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties ... Class II MEDLINE INDUSTRIES, LP - Northfield
Nov 21, 2024 Medline custom medical procedure kits labeled as: 1) CERVICAL PACK-LF, REF... Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties ... Class II MEDLINE INDUSTRIES, LP - Northfield
Nov 21, 2024 Medline custom medical procedure kits labeled as: 1) ENSEMBLE RACHIS-LF, R... Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties ... Class II MEDLINE INDUSTRIES, LP - Northfield
Nov 21, 2024 Medline custom medical procedure kits labeled as: 1) OPEN HEART CDS-LF, RE... Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties ... Class II MEDLINE INDUSTRIES, LP - Northfield
Nov 18, 2024 Access hsTnI Reagent, REF B52699, Immunoassay Method, Troponin Subunit. For ... Beckman Coulter, Inc. is recalling their Access hsTnI assay, a medical device by correction. The ... Class II Beckman Coulter, Inc.
Nov 12, 2024 ST IUD REMOVAL HOOK 10" (504090), Medline Item No. I68785 Weak seals may result in a breach of sterility, which may not be detectable to the user. This can... Class II MEDLINE INDUSTRIES, LP - Northfield
Nov 12, 2024 STERILE STRT KELLY HEMOSTAT (SK8039S), Medline Item No. 66695 Weak seals may result in a breach of sterility, which may not be detectable to the user. This can... Class II MEDLINE INDUSTRIES, LP - Northfield
Nov 12, 2024 RUMMELL, Medline Item No. ST006ST Weak seals may result in a breach of sterility, which may not be detectable to the user. This can... Class II MEDLINE INDUSTRIES, LP - Northfield
Nov 12, 2024 O.R. SCISSORS, S/B, 5.5 STERILE, Medline Item No. DYND04000 Weak seals may result in a breach of sterility, which may not be detectable to the user. This can... Class II MEDLINE INDUSTRIES, LP - Northfield
Nov 12, 2024 STERILE MAGILL FORCEP (MAGF9), Medline Item No. 66790 Weak seals may result in a breach of sterility, which may not be detectable to the user. This can... Class II MEDLINE INDUSTRIES, LP - Northfield
Nov 12, 2024 ST OR MAYO HEGAR NEEDLEHOLDER 6"(OR2500), Medline Item No. 67870 Weak seals may result in a breach of sterility, which may not be detectable to the user. This can... Class II MEDLINE INDUSTRIES, LP - Northfield
Nov 12, 2024 ST REPROCESSED BRUNS CURETTE #00 (BC00), Medline Item No. 67600K Weak seals may result in a breach of sterility, which may not be detectable to the user. This can... Class II MEDLINE INDUSTRIES, LP - Northfield
Nov 8, 2024 Cardinal Health Presource Kits: 1 ) TRIPLE ENDO PACK, Catalog Number: SBAOCT... Potential endotoxin contamination in non-sterile surgical strips and patties in Presource kits. Class II Cardinal Health 200, LLC
Nov 8, 2024 Cardinal Health Presource Kits: 1) OPHTHALMOLOGY ENDO DCR XTRS PK, Catalog N... Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits. Class II Cardinal Health 200, LLC
Nov 8, 2024 Cardinal Health Presource Kits: 1) ACDF PACK, Catalog Number: SNEHBACSCA; 2... Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits. Class II Cardinal Health 200, LLC
Nov 8, 2024 Cardinal Health Presource Kits: 1) KIT,NEURO LAMI,MD ANDERSON, Catalog Numbe... Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits. Class II Cardinal Health 200, LLC
Nov 8, 2024 Cardinal Health Presource Kits: 0 ) DESCRIPTION Catalog Number: CATALOG #; 1 ... Potential endotoxin contamination in non-sterile surgical strips and patties in Presource kits. Class II Cardinal Health 200, LLC
Nov 8, 2024 Cardinal Health Presource Kits: 1) CHI STD NEURO CRANI OPT 1, Catalog Number:... Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits. Class II Cardinal Health 200, LLC
Nov 8, 2024 Cardinal Health Presource Kits: 1 ) KIT, MAJOR ORAL SURGERY, Catalog Number:... Potential endotoxin contamination in non-sterile surgical strips and patties in Presource kits. Class II Cardinal Health 200, LLC
Nov 8, 2024 Cardinal Health Presource Kits: 1 ) LARYNGOSCOPY PACK, Catalog Number: SEN11... Potential endotoxin contamination in non-sterile surgical strips and patties in Presource kits. Class II Cardinal Health 200, LLC
Nov 8, 2024 Cardinal Health Presource Kits: 1) CHI STD SPINE OPTION 1, Catalog Number:CHI... Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits. Class II Cardinal Health 200, LLC
Nov 8, 2024 Cardinal Health Presource Kits: 1) KIT,MAXILLOFACIAL,PRESBYTERIAN, Catalog N... Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits. Class II Cardinal Health 200, LLC
Nov 8, 2024 Cardinal Health Presource Kits: 1) ORTHO PLASTIC MICROVASCULAR PK , Catalog N... Potential endotoxin contamination in non-sterile surgical strips and patties in Presource kits. Class II Cardinal Health 200, LLC
Nov 8, 2024 Cardinal Health Presource Kits: 1) CRANIOTOMY PACK, Catalog Number: 2NE69CNK... Potential endotoxin contamination in non-sterile surgical strips and patties in Presource kits. Class II Cardinal Health 200, LLC
Nov 8, 2024 Cardinal Health Presource Kits: 1) KIT,NASAL SEPTOPLASTY,FAIRVIEW, Catalog Nu... Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits. Class II Cardinal Health 200, LLC
Nov 8, 2024 Cardinal Health Presource Kits: 1) KIT, CAROTID ENDARTERECTOMY, Catalog Numb... Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits. Class II Cardinal Health 200, LLC
Nov 8, 2024 Cardinal Health Presource Kits: 1) KIT,ROBOTIC HYSTERECTOMY, Catalog Number:... Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits. Class II Cardinal Health 200, LLC
Nov 8, 2024 Cardinal Health Presource Kits: 1) KIT,PLASTIC FLAP,Catalog Number PGHDOT951... Potential endotoxin contamination in non-sterile surgical strips and patties in Presource kits. Class II Cardinal Health 200, LLC
Nov 8, 2024 Cardinal Health Presource Kits: 1) LARYNGOSCOPY PACK, Catalog Number:SRIET09... Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits. Class II Cardinal Health 200, LLC
Nov 8, 2024 Cardinal Health Presource Kits: 1) UROLOGY ROBOTIC PACK, Catalog Number:SOT4... Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits. Class II Cardinal Health 200, LLC
Nov 8, 2024 Cardinal Health Presource Kits: 1 ) KIT, FETAL SURGERY, Catalog Number PB11F... Potential endotoxin contamination in non-sterile surgical strips and patties in Presource kits. Class II Cardinal Health 200, LLC
Nov 8, 2024 Cardinal Health Presource Kits: 1) KIT, H N FREE FLAP, Catalog Number: PEHFH... Potential endotoxin contamination in non-sterile surgical strips and patties in Presource kits. Class II Cardinal Health 200, LLC
Nov 8, 2024 Cardinal Health Presource Kits: 1 ) ANEURYSM PACK , Catalog Number: SCVHFAPB... Potential endotoxin contamination in non-sterile surgical strips and patties in Presource kits. Class II Cardinal Health 200, LLC
Nov 8, 2024 Cardinal Health Presource Kits: 1) KIT,DIEP FLAP , Catalog N... Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits. Class II Cardinal Health 200, LLC
Aug 23, 2024 BIOTROL PURIT Clean-It General Purpose Ultrasonic Cleaner, REF PC016, net con... The bulk product used in the recalling firm's repackaged finished product was recalled due to bac... Class II Young Dental Manufacturing I, LLC
Aug 14, 2024 3M Tegaderm CHG, Chlorhexidine Gluconate I.V. Securement Dressing, REF 1658R Contamination with foreign substance matter Class II 3M Company - Health Care Business
Jul 10, 2024 The VITROS XT Chemistry Products ALB-TP Slides is a single device that contai... The reason for this recall is QuidelOrtho has determined that during normal use the VITROS XT ALB... Class II Ortho-Clinical Diagnostics, Inc.
Jul 2, 2024 BioPince Ultra Full Core Biopsy Instrument: REF: REF: 360-1080-01, 360-1080-0... Holes have been identified in biopsy instrument packaging trays compromising the sterile barrier,... Class II Argon Medical Devices, Inc
Jun 20, 2024 Cepheid, Sample Collection Device, Part: 900-0370 Specimen collection device may leak after the patient sample swabs have been inserted into the te... Class II Cepheid
Jun 13, 2024 Hookup Model/Catalog Number: DSD-110-HU0163 Product Description: Hookups ... IFU for hookup were incorrectly reflected within hookup IFUs and online reference system, Hookup ... Class II Steris Corporation
Jun 13, 2024 Hookup Model/Catalog Number: 2-8-540HAN Product Description: Hookups prov... IFU for hookup were incorrectly reflected within hookup IFUs and online reference system, Hookup ... Class II Steris Corporation

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.