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.

Clear

Date	Product	Reason	Class	Firm
Oct 24, 2017	rHead Recon Stem Implant non-coated, Size 2. 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	rHead Recon Extended Stem Size 1. 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	rHead Standard Extended Stem, 6mm Collar, 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	Lateral Assembly, Radial Head 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	rHead Stem Implant 6mm Collar, Size 4.Orthopedic implant for replacement of t...	Revision rate identified as higher than other proximal radial head replacement devices based on l...	Class II	Howmedica Osteonics Corp.
Oct 24, 2017	#3 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.
Oct 24, 2017	rHead Recon Stem Implant Plasma Coated, Size 2. 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	Radio Capitellum, Recon Head, Size #4. 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	rHead, Radial Implant 6 mm Collar, Size 4. 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 Extended Stem Size 3. 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	rHead Recon Stem Implant 6mm Collar, Size 3. 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	Pneumothorax Kit	Product packaging may not be completely sealed.	Class II	Arrow International Inc
Oct 24, 2017	rHead Stem Implant 6mm Collar, 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	rHead Recon Stem Implant Plasma Coated, Size 3. 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	#4 Bipolar stem implant (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 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	Radio Capitellum, Recon Head, 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	Argyle Suction Tubing (Product # 8888301515) Argyle Suction Tubing is an ...	Incorrect packaging. In one lot of Argyle Suction Tubing, the pouch may be incorrectly labeled as...	Class II	Medtronic Minimally Invasive Therapies Group
Oct 24, 2017	Radio Capitellum Broach Large, Right. 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	rHead Standard Extended Stem, 6mm Collar, Size 2. 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 Assy Size #4, Rad. 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	smith&nephew TRIGEN INTERTAN 10S, REF 71675384, 10 MM X 18 CM NAIL, 130o (deg...	A single lot of INTERTAN 10S 10 MM X 18 CM 130 D was manufactured with the screw inserted upside ...	Class II	Smith & Nephew, Inc.
Oct 24, 2017	#3 Bipolar stem implant (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	#1 Bipolar stem implant (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 Recon Stem Implant 6mm 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	Radio Capitellum Large, 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	#2 Bipolar stem implant (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	Lateral Assembly, Radial Head 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	Lateral Assembly, Radial Head Impl Assembly, Size 3. Orthopedic implant for r...	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 #1 (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 Recon Stem Implant Plasma Coated, Size 4. 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	Lateral Assembly, Radial Head Impl Assembly, Size 2. Orthopedic implant for r...	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 2. 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	#4 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.
Oct 24, 2017	rHead Recon Stem Implant non-coated, Size 1. 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	Lateral Assembly, Radial Head Impl Assembly, Size 4. Orthopedic implant for r...	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, 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	radial stem 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	The GMK knee system: designed for cemented use in total knee arthroplasty. S...	Medacta has observed a worldwide occurrence rate of post-operative insert screw back-out of appro...	Class II	Medacta Usa Inc
Oct 23, 2017	CIRCUMCISION TRAY	Convenience Kit contains a PVP Prep Pad, received by a supplier, that does not meet the iodine as...	Class II	Centurion Medical Products Corporation
Oct 23, 2017	ST. CHRISTOPHER'S SECUREMENT SET	Convenience Kit contains a PVP Prep Pad, received by a supplier, that does not meet the iodine as...	Class II	Centurion Medical Products Corporation
Oct 23, 2017	PEDIATRIC IV & IV START KIT	Convenience Kit containing components to assist practitioner with IV placement and securement.	Class II	Centurion Medical Products Corporation
Oct 23, 2017	SKIN STAPLE REMOVER	Convenience Kit contains a PVP Prep Pad, received by a supplier, that does not meet the iodine as...	Class II	Centurion Medical Products Corporation
Oct 23, 2017	WOUND CLOSURE TRAY - FACIAL	Convenience Kit containing components to assist practitioner with IV placement and securement.	Class II	Centurion Medical Products Corporation
Oct 23, 2017	TUBING CHANGE KIT	Convenience Kit contains a PVP Prep Pad, received by a supplier, that does not meet the iodine as...	Class II	Centurion Medical Products Corporation
Oct 23, 2017	INCISION & DRAINAGE TRAY or KIT	Convenience Kit contains a PVP Prep Pad, received by a supplier, that does not meet the iodine as...	Class II	Centurion Medical Products Corporation
Oct 23, 2017	WOUND CARE KIT	Convenience Kit containing components to assist practitioner with IV placement and securement.	Class II	Centurion Medical Products Corporation
Oct 23, 2017	EXCISION TRAY	Convenience Kit containing components to assist practitioner with IV placement and securement.	Class II	Centurion Medical Products Corporation
Oct 23, 2017	MINOR DRESSING CHANGE TRAY	Convenience Kit contains a PVP Prep Pad, received by a supplier, that does not meet the iodine as...	Class II	Centurion Medical Products Corporation
Oct 23, 2017	BLOOD DRAW KIT	Convenience Kit contains a PVP Prep Pad, received by a supplier, that does not meet the iodine as...	Class II	Centurion Medical Products 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.