Browse Device Recalls

3,313 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,313 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 3,313 FDA device recalls in 2017.

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Date	Product	Reason	Class	Firm
Oct 26, 2017	SUR-FIT Natura Moldable Durahesive Skin Barrier with Hydrocolloid Flexible Co...	A portion of Lot 7H02242 outer boxes (market units) of the SUR-FIT Natura Moldable Durahesive Ski...	Class II	ConvaTec, Inc
Oct 26, 2017	Radial Artery Catheterization Kit; Model: AK-04122	The povidone iodine prep pads included in certain kits and trays do not meet the requirements for...	Class II	Arrow International Inc
Oct 26, 2017	Radial Artery Catheterization Kit; Model: AK-04020	The povidone iodine prep pads included in certain kits and trays do not meet the requirements for...	Class II	Arrow International Inc
Oct 26, 2017	Radial Artery Catheterization Kit; Model: AK-04220	The povidone iodine prep pads included in certain kits and trays do not meet the requirements for...	Class II	Arrow International Inc
Oct 25, 2017	fastener, fixation, nondegradable, soft tissue	It was identified that the product was not assembled correctly causing the implant shaft to shift...	Class II	Zimmer Biomet, Inc.
Oct 25, 2017	A.L.P.S. MIS Calcaneus Locking Plate LG RT F.A.S.T. Guide inserts, Item Numbe...	The drill guides were manufactured with the incorrect color anodization.	Class II	Zimmer Biomet, Inc.
Oct 25, 2017	Neoplastine¿ Cl Plus @ (ref.00374) Product Usage: Manual or automated de...	Confirmed defect of homogeneity where some reagent vials will give prolonged Prothrombin Time (de...	Class II	Diagnostica Stago, Inc.
Oct 25, 2017	STA - Neoplastine¿ Cl ¿ (ref. 00605) Product Usage: Manual or automated d...	Confirmed defect of homogeneity where some reagent vials will give prolonged Prothrombin Time (de...	Class II	Diagnostica Stago, Inc.
Oct 25, 2017	Neoplastine¿ Cl Plus ¿ (ref. 00375) Product Usage: Manual or automated d...	Confirmed defect of homogeneity where some reagent vials will give prolonged Prothrombin Time (de...	Class II	Diagnostica Stago, Inc.
Oct 25, 2017	STA - Neoplastine¿ Cl Plus ¿ (ref. 00606) Product Usage: Manual or automa...	Confirmed defect of homogeneity where some reagent vials will give prolonged Prothrombin Time (de...	Class II	Diagnostica Stago, Inc.
Oct 24, 2017	rHead Recon Stem Implant Plasma Coated, Size 1. Orthopedic implant for replac...	Revision rate identified as higher than other proximal radial head replacement devices based on l...	Class II	Howmedica Osteonics Corp.
Oct 24, 2017	rHead, Radial Implant 6 mm Collar, Size 1. Orthopedic implant for replacemen...	Revision rate identified as higher than other proximal radial head replacement devices based on l...	Class II	Howmedica Osteonics Corp.
Oct 24, 2017	rHead Recon Stem Implant 6mm Collar, Size 4. Orthopedic implant for replaceme...	Revision rate identified as higher than other proximal radial head replacement devices based on l...	Class II	Howmedica Osteonics Corp.
Oct 24, 2017	Radio Capitellum Small, Right. Orthopedic implant for replacement of the pro...	Revision rate identified as higher than other proximal radial head replacement devices based on l...	Class II	Howmedica Osteonics Corp.
Oct 24, 2017	rHead Standard Extended Stem, 6mm Collar, Size 1. Orthopedic implant for rep...	Revision rate identified as higher than other proximal radial head replacement devices based on l...	Class II	Howmedica Osteonics Corp.
Oct 24, 2017	rHead, Radial Implant 6 mm Collar, Size 3. Orthopedic implant for replacemen...	Revision rate identified as higher than other proximal radial head replacement devices based on l...	Class II	Howmedica Osteonics Corp.
Oct 24, 2017	Lat Assembly, Rad Stem Implant,Collar 6mm,Size 3. Orthopedic implant for repl...	Revision rate identified as higher than other proximal radial head replacement devices based on l...	Class II	Howmedica Osteonics Corp.
Oct 24, 2017	rHead Stem Implant Plasma Coated, Size 1. Orthopedic implant for replacement ...	Revision rate identified as higher than other proximal radial head replacement devices based on l...	Class II	Howmedica Osteonics Corp.
Oct 24, 2017	rHead Recon Stem Implant 6mm Collar, Size 2. Orthopedic implant for replaceme...	Revision rate identified as higher than other proximal radial head replacement devices based on l...	Class II	Howmedica Osteonics Corp.
Oct 24, 2017	rHead Recon Extended Stem Size 2. Orthopedic implant for replacement of the ...	Revision rate identified as higher than other proximal radial head replacement devices based on l...	Class II	Howmedica Osteonics Corp.
Oct 24, 2017	radial stem implant #2 (Sterile packed). Orthopedic implant for replacement ...	Revision rate identified as higher than other proximal radial head replacement devices based on l...	Class II	Howmedica Osteonics Corp.
Oct 24, 2017	rHead Stem Implant 6mm Collar, Size 3. Orthopedic implant for replacement of ...	Revision rate identified as higher than other proximal radial head replacement devices based on l...	Class II	Howmedica Osteonics Corp.
Oct 24, 2017	Lateral Assembly, Radial Implant, Size 1 Orthopedic implant for replacement o...	Revision rate identified as higher than other proximal radial head replacement devices based on l...	Class II	Howmedica Osteonics Corp.
Oct 24, 2017	Lateral Assembly, Radial Stem Implant, Size 4. Orthopedic implant for replace...	Revision rate identified as higher than other proximal radial head replacement devices based on l...	Class II	Howmedica Osteonics Corp.
Oct 24, 2017	Lateral Assembly, Radial Stem Implant, Size 3. Orthopedic implant for replace...	Revision rate identified as higher than other proximal radial head replacement devices based on l...	Class II	Howmedica Osteonics Corp.
Oct 24, 2017	Persona Partial Knee Spacer Blocks To assist in partial knee arthroplasty ...	Zimmer Biomet is conducting a medical device recall for the Persona Partial Knee Spacer Blocks in...	Class II	Zimmer Biomet, Inc.
Oct 24, 2017	Lat Assembly, Rad Stem Implant,Collar 6mm,Size 4. Orthopedic implant for repl...	Revision rate identified as higher than other proximal radial head replacement devices based on l...	Class II	Howmedica Osteonics Corp.
Oct 24, 2017	radial head implant #2 (Sterile packed). Orthopedic implant for replacement ...	Revision rate identified as higher than other proximal radial head replacement devices based on l...	Class II	Howmedica Osteonics Corp.
Oct 24, 2017	rHead Stem Implant Plasma Coated, Size 3. Orthopedic implant for replacement ...	Revision rate identified as higher than other proximal radial head replacement devices based on l...	Class II	Howmedica Osteonics Corp.
Oct 24, 2017	Radial Head Assy Size #2, Rad. Orthopedic implant for replacement of the pro...	Revision rate identified as higher than other proximal radial head replacement devices based on l...	Class II	Howmedica Osteonics Corp.
Oct 24, 2017	Radial Head Assy Size #3, Rad. Orthopedic implant for replacement of the pro...	Revision rate identified as higher than other proximal radial head replacement devices based on l...	Class II	Howmedica Osteonics Corp.
Oct 24, 2017	Lat Assembly, Rad Stem Implant,Collar 6mm, Size1. Orthopedic implant for repl...	Revision rate identified as higher than other proximal radial head replacement devices based on l...	Class II	Howmedica Osteonics Corp.
Oct 24, 2017	rHead Recon Stem Implant non-coated, Size 3. Orthopedic implant for replacem...	Revision rate identified as higher than other proximal radial head replacement devices based on l...	Class II	Howmedica Osteonics Corp.
Oct 24, 2017	radial stem implant #4 (Sterile packed). Orthopedic implant for replacement ...	Revision rate identified as higher than other proximal radial head replacement devices based on l...	Class II	Howmedica Osteonics Corp.
Oct 24, 2017	radial head implant #3 (Sterile packed). Orthopedic implant for replacement ...	Revision rate identified as higher than other proximal radial head replacement devices based on l...	Class II	Howmedica Osteonics Corp.
Oct 24, 2017	ArrowClarke" PleuraSeal¿ Thoracentesis Kit	Product packaging may not be completely sealed.	Class II	Arrow International Inc
Oct 24, 2017	rHead Standard Extended Stem, 6mm Collar, Size 3. Orthopedic implant for rep...	Revision rate identified as higher than other proximal radial head replacement devices based on l...	Class II	Howmedica Osteonics Corp.
Oct 24, 2017	AMS, ALIGNED MEDICAL SOLUTIONS, T&A Pack, AMS6357, STERILE EO.	Custom surgical kits were manufactured with part #63310 Catheter Urethral 10FR 16" which were sub...	Class II	Windstone Medical Packaging, Inc.
Oct 24, 2017	ABL800 analyzer with FLEXQ module. Device intended for in vitro testing of...	Due to misinterpretation of the barcode by the scanner, when the registration receipt barcode is ...	Class II	Radiometer America Inc
Oct 24, 2017	rHead Stem Implant Plasma Coated, Size 2. Orthopedic implant for replacement ...	Revision rate identified as higher than other proximal radial head replacement devices based on l...	Class II	Howmedica Osteonics Corp.
Oct 24, 2017	Lateral Assembly, Radial Stem Implant, Size 2. Orthopedic implant for replace...	Revision rate identified as higher than other proximal radial head replacement devices based on l...	Class II	Howmedica Osteonics Corp.
Oct 24, 2017	rHead Stem Implant 6mm Collar, Size 1. Orthopedic implant for replacement of ...	Revision rate identified as higher than other proximal radial head replacement devices based on l...	Class II	Howmedica Osteonics Corp.
Oct 24, 2017	Lateral Assembly, Radial Head Implant, Size 2. Orthopedic implant for replace...	Revision rate identified as higher than other proximal radial head replacement devices based on l...	Class II	Howmedica Osteonics Corp.
Oct 24, 2017	rHead Recon Stem Implant non-coated, Size 4. Orthopedic implant for replaceme...	Revision rate identified as higher than other proximal radial head replacement devices based on l...	Class II	Howmedica Osteonics Corp.
Oct 24, 2017	radial head implant #4 (Sterile packed). Orthopedic implant for replacement ...	Revision rate identified as higher than other proximal radial head replacement devices based on l...	Class II	Howmedica Osteonics Corp.
Oct 24, 2017	rHead Stem Implant Plasma Coated, Size 4. Orthopedic implant for replacement ...	Revision rate identified as higher than other proximal radial head replacement devices based on l...	Class II	Howmedica Osteonics Corp.
Oct 24, 2017	Radio Capitellum, Recon Head, Size #2. Orthopedic implant for replacement of...	Revision rate identified as higher than other proximal radial head replacement devices based on l...	Class II	Howmedica Osteonics Corp.
Oct 24, 2017	Large Volume Abdominal Paracentesis Kit	Product packaging may not be completely sealed.	Class II	Arrow International Inc
Oct 24, 2017	Radio Capitellum Large, Left Orthopedic implant for replacement of the prox...	Revision rate identified as higher than other proximal radial head replacement devices based on l...	Class II	Howmedica Osteonics Corp.
Oct 24, 2017	#2 Bipolar radial head Implant (Sterile packed). Orthopedic implant for repl...	Revision rate identified as higher than other proximal radial head replacement devices based on l...	Class II	Howmedica Osteonics Corp.

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.