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Browse Device Recalls

1,125 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 1,125 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 1,125 FDA device recalls.

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DateProductReasonClassFirm
Jul 17, 2018 Affixus¿ Hip Fracture Nail Left 130¿ 13 mm x 380 mm, Item Number: 814613380 The set screw is not able to advance or reverse from the original position in the nail. Class II Zimmer Biomet, Inc.
Jul 17, 2018 Affixus¿ Hip Fracture Nail Right 130¿ 13 mm x 280 mm, Item Number: 814513280 The set screw is not able to advance or reverse from the original position in the nail. Class II Zimmer Biomet, Inc.
Jul 17, 2018 Affixus¿ Hip Fracture Nail Left 130¿ 13 mm x 400 mm, Item Number: 814613400 The set screw is not able to advance or reverse from the original position in the nail. Class II Zimmer Biomet, Inc.
Jul 17, 2018 Affixus¿ Hip Fracture Nail Left 130¿ 13 mm x 440 mm, Item Number: 814613440 The set screw is not able to advance or reverse from the original position in the nail. Class II Zimmer Biomet, Inc.
Jul 17, 2018 Affixus¿ Hip Fracture Nail Left 130¿ 9 mm x 360 mm, Item Number: 814609360 The set screw is not able to advance or reverse from the original position in the nail. Class II Zimmer Biomet, Inc.
Jul 17, 2018 Affixus¿ Hip Fracture Nail Left 125¿ 11 mm x 460 mm, Item Number: 814411460 The set screw is not able to advance or reverse from the original position in the nail. Class II Zimmer Biomet, Inc.
Jul 17, 2018 Affixus¿ Hip Fracture Nail Right 130¿ 13 mm x 340 mm, Item Number: 814513340 The set screw is not able to advance or reverse from the original position in the nail. Class II Zimmer Biomet, Inc.
Jul 17, 2018 Affixus¿ Hip Fracture Nail Left 125¿ 13 mm x 320 mm, Item Number: 814413320 The set screw is not able to advance or reverse from the original position in the nail. Class II Zimmer Biomet, Inc.
Jul 17, 2018 Affixus¿ Hip Fracture Nail Left 130¿ 13 mm x 300 mm, Item Number: 814613300 The set screw is not able to advance or reverse from the original position in the nail. Class II Zimmer Biomet, Inc.
Jul 17, 2018 Affixus¿ Hip Fracture Nail Right 125¿ 13 mm x 340 mm, Item Number: 814313340 The set screw is not able to advance or reverse from the original position in the nail. Class II Zimmer Biomet, Inc.
Jul 17, 2018 Affixus¿ Hip Fracture Nail Left 125¿ 9 mm x 400 mm, Item Number: 814409400 The set screw is not able to advance or reverse from the original position in the nail. Class II Zimmer Biomet, Inc.
Jul 17, 2018 Affixus¿ Hip Fracture Nail Right 125¿ 9 mm x 320 mm, Item Number: 814309320 The set screw is not able to advance or reverse from the original position in the nail. Class II Zimmer Biomet, Inc.
Jul 17, 2018 Affixus¿ Hip Fracture Nail Right 130¿ 13 mm x 400 mm, Item Number: 814513400 The set screw is not able to advance or reverse from the original position in the nail. Class II Zimmer Biomet, Inc.
Jul 17, 2018 Affixus¿ Hip Fracture Nail Left 130¿ 13 mm x 420 mm, Item Number: 814613420 The set screw is not able to advance or reverse from the original position in the nail. Class II Zimmer Biomet, Inc.
Jul 17, 2018 Affixus¿ Hip Fracture Nail Right 125¿ 13 mm x 300 mm, Item Number: 814313300 The set screw is not able to advance or reverse from the original position in the nail. Class II Zimmer Biomet, Inc.
Jul 17, 2018 Affixus¿ Hip Fracture Nail Left 130¿ 13 mm x 340 mm, Item Number: 814613340 The set screw is not able to advance or reverse from the original position in the nail. Class II Zimmer Biomet, Inc.
Jul 17, 2018 Affixus¿ Hip Fracture Nail Right 125¿ 11 mm x 300 mm, Item Number: 814311300 The set screw is not able to advance or reverse from the original position in the nail. Class II Zimmer Biomet, Inc.
Jul 17, 2018 Affixus¿ Hip Fracture Nail 125¿ 11 mm x 180 mm, Item Number: 814311180 The set screw is not able to advance or reverse from the original position in the nail. Class II Zimmer Biomet, Inc.
Jul 17, 2018 Affixus¿ Hip Fracture Nail Right 125¿ 13 mm x 180 mm, Item Number: 814313180 The set screw is not able to advance or reverse from the original position in the nail. Class II Zimmer Biomet, Inc.
Jul 17, 2018 Affixus¿ Hip Fracture Nail Left 125¿ 13 mm x 420 mm, Item Number: 814413420 The set screw is not able to advance or reverse from the original position in the nail. Class II Zimmer Biomet, Inc.
Jul 17, 2018 Affixus¿ Hip Fracture Nail Left 130¿ 11 mm x 460 mm, Item Number: 814611460 The set screw is not able to advance or reverse from the original position in the nail. Class II Zimmer Biomet, Inc.
Jul 17, 2018 Affixus¿ Hip Fracture Nail Left 125¿ 13 mm x 260 mm, Item Number: 814413260 The set screw is not able to advance or reverse from the original position in the nail. Class II Zimmer Biomet, Inc.
Jul 17, 2018 Affixus¿ Hip Fracture Nail Left 125¿ 9 mm x 360 mm, Item Number: 814409360 The set screw is not able to advance or reverse from the original position in the nail. Class II Zimmer Biomet, Inc.
Jul 17, 2018 Affixus¿ Hip Fracture Nail 125¿ 9 mm x 180 mm, Item Number: 814309180 The set screw is not able to advance or reverse from the original position in the nail. Class II Zimmer Biomet, Inc.
Jul 17, 2018 Affixus¿ Hip Fracture Nail Right 130¿ 15 mm x 360 mm, Item Number: 814515360 The set screw is not able to advance or reverse from the original position in the nail. Class II Zimmer Biomet, Inc.
Jul 17, 2018 Affixus¿ Hip Fracture Nail Left 130¿ 13 mm x 280 mm, Item Number: 814613280 The set screw is not able to advance or reverse from the original position in the nail. Class II Zimmer Biomet, Inc.
Jul 17, 2018 Affixus¿ Hip Fracture Nail Right 130¿ 9 mm x 380 mm, Item Number: 814509380 The set screw is not able to advance or reverse from the original position in the nail. Class II Zimmer Biomet, Inc.
Jul 17, 2018 Affixus¿ Hip Fracture Nail Left 125¿ 9 mm x 300 mm, Item Number: 814409300 The set screw is not able to advance or reverse from the original position in the nail. Class II Zimmer Biomet, Inc.
Jul 17, 2018 Affixus¿ Hip Fracture Nail Right 130¿ 9 mm x 360 mm, Item Number: 814509360 The set screw is not able to advance or reverse from the original position in the nail. Class II Zimmer Biomet, Inc.
Jul 17, 2018 Affixus¿ Hip Fracture Nail Left 130¿ 11 mm x 400 mm, Item Number: 814611400 The set screw is not able to advance or reverse from the original position in the nail. Class II Zimmer Biomet, Inc.
Jul 17, 2018 Affixus¿ Hip Fracture Nail Right 130¿ 15 mm x 400 mm, Item Number: 814515400 The set screw is not able to advance or reverse from the original position in the nail. Class II Zimmer Biomet, Inc.
Jul 17, 2018 Affixus¿ Hip Fracture Nail Left 130¿ 11 mm x 360 mm, Item Number: 814611360 The set screw is not able to advance or reverse from the original position in the nail. Class II Zimmer Biomet, Inc.
Jul 17, 2018 Affixus¿ Hip Fracture Nail Right 130¿ 11 mm x 280 mm, Item Number: 814511280 The set screw is not able to advance or reverse from the original position in the nail. Class II Zimmer Biomet, Inc.
Jul 17, 2018 Affixus¿ Hip Fracture Nail Left 125¿ 11 mm x 360 mm, Item Number: 814411360 The set screw is not able to advance or reverse from the original position in the nail. Class II Zimmer Biomet, Inc.
Jul 17, 2018 Affixus¿ Hip Fracture Nail Right 130¿ 13 mm x 460 mm, Item Number: 814513460 The set screw is not able to advance or reverse from the original position in the nail. Class II Zimmer Biomet, Inc.
Jul 17, 2018 Affixus¿ Hip Fracture Nail Right 125¿ 9 mm x 460 mm, Item Number: 814309460 The set screw is not able to advance or reverse from the original position in the nail. Class II Zimmer Biomet, Inc.
Jul 17, 2018 Affixus¿ Hip Fracture Nail Right 125¿ 9 mm x 440 mm, Item Number: 814309440 The set screw is not able to advance or reverse from the original position in the nail. Class II Zimmer Biomet, Inc.
Jul 12, 2018 Peg Fully Threaded, Locking, 2.5mm x 10mm, Item Number 131212610 Orthopedic d... A size 22mm threaded peg was found in the package of a 10mm unit. Class II Zimmer Biomet, Inc.
Jun 22, 2018 Persona Partial Knee System Spacer Block Alignment Tower, Item No. 42-5399-00... The PPK System Spacer Block Alignment Tower mating feature that mates with the spacer block was u... Class II Zimmer Biomet, Inc.
Jun 18, 2018 Connecting Bolt, Model 14-442093 Product was manufactured from the incorrect material, which shows a potential decrease in the fat... Class II Zimmer Biomet, Inc.
Jun 8, 2018 ECHO Bi-Metric Hip System, Reduced Proximal Profile, Standard 135o neck, item... Two lots of the Echo BI-Metric Hip Stem and ARCOS Modular Revision Hip Stem may have been comingl... Class II Zimmer Biomet, Inc.
Jun 8, 2018 ARCOS Modular Revision Hip System, item number 11-300814 orthopedic hip pros... Two lots of the Echo BI-Metric Hip Stem and ARCOS Modular Revision Hip Stem may have been comingl... Class II Zimmer Biomet, Inc.
May 30, 2018 Zimmer¿ M/L Taper Hip Prosthesis With Kinective¿ Technology Cementless, Size ... Class II Zimmer Biomet, Inc.
May 30, 2018 Zimmer¿ M/L Taper Hip Prosthesis With Kinective¿ Technology Cementless, Size ... M/L Taper Hip Prosthesis and M/L Taper Hip Prosthesis with Kinectiv Technology manufactured prior... Class II Zimmer Biomet, Inc.
May 30, 2018 Zimmer M/L Taper Hip Prosthesis Plasma Sprayed, Size 4 Extended Offset, 00-77... M/L Taper Hip Prosthesis and M/L Taper Hip Prosthesis with Kinectiv Technology manufactured prior... Class II Zimmer Biomet, Inc.
May 30, 2018 Zimmer¿ M/L Taper Hip Prosthesis With Kinective¿ Technology Cementless, Size ... M/L Taper Hip Prosthesis and M/L Taper Hip Prosthesis with Kinectiv Technology manufactured prior... Class II Zimmer Biomet, Inc.
May 30, 2018 Zimmer¿ M/L Taper Hip Prosthesis With Kinective¿ Technology Cementless, Size ... M/L Taper Hip Prosthesis and M/L Taper Hip Prosthesis with Kinectiv Technology manufactured prior... Class II Zimmer Biomet, Inc.
May 30, 2018 Zimmer¿ M/L Taper Hip Prosthesis With Kinective¿ Technology Cementless, Size ... M/L Taper Hip Prosthesis and M/L Taper Hip Prosthesis with Kinectiv Technology manufactured prior... Class II Zimmer Biomet, Inc.
May 30, 2018 Zimmer¿ M/L Taper Hip Prosthesis With Kinective¿ Technology Cementless, Size ... M/L Taper Hip Prosthesis and M/L Taper Hip Prosthesis with Kinectiv Technology manufactured prior... Class II Zimmer Biomet, Inc.
May 30, 2018 Zimmer¿ M/L Taper Hip Prosthesis With Kinective¿ Technology Cementless, Size ... M/L Taper Hip Prosthesis and M/L Taper Hip Prosthesis with Kinectiv Technology manufactured prior... Class II Zimmer Biomet, 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.