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Browse Device Recalls

875 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 875 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 875 FDA device recalls.

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DateProductReasonClassFirm
Oct 22, 2018 Zimmer ZMS¿ Intramedullary Fixation Smooth Guide Wire, 2.4 mm Diameter, 100 c... Various Trauma Guide Wires- creases in the sealing area on the end opposite of the product's chev... Class II Zimmer Biomet, Inc.
Oct 12, 2018 Zimmer Compress Devices and Instruments: Item Number/Item Description 17835... Correction to update the surgical technique for the Compress System. To make users aware of the c... Class II Zimmer Biomet, Inc.
Oct 10, 2018 Comprehensive Mini Stem, Item No. 113631: Zimmer Biomet is conducting a lot specific medical device recall for two lots of the Orthopedic S... Class II Zimmer Biomet, Inc.
Oct 10, 2018 Orthopedic Salvage System (OSS) Porous Stem, Item No. 150394 Zimmer Biomet is conducting a lot specific medical device recall for two lots of the Orthopedic S... Class II Zimmer Biomet, Inc.
Oct 2, 2018 Affixus Hip Fracture Nail 130 Deg 12x165mm, Item Number 816812165 The Aff... The set screw is not able to advance or reverse from the original position in the nail. Class II Zimmer Biomet, Inc.
Oct 2, 2018 Affixus Hip Fracture Nail Left Deg 9x300mm, Item Number 814609300 The Aff... The set screw is not able to advance or reverse from the original position in the nail. Class II Zimmer Biomet, Inc.
Oct 2, 2018 Affixus Hip Fracture Nail 125 Deg 10x165mm, Item Number 816710165 The Aff... The set screw is not able to advance or reverse from the original position in the nail. Class II Zimmer Biomet, Inc.
Oct 2, 2018 Affixus Hip Fracture Nail Left 125 Deg 11x300mm, Item Number 814411300 Th... The set screw is not able to advance or reverse from the original position in the nail. Class II Zimmer Biomet, Inc.
Oct 2, 2018 Affixus Hip Fracture Nail Left 125 Deg 9x165mm, Item Number 816709165 The... The set screw is not able to advance or reverse from the original position in the nail. Class II Zimmer Biomet, Inc.
Oct 2, 2018 Affixus Hip Fracture Nail Left 130 Deg 11x300mm, Item Number 814611300 Th... The set screw is not able to advance or reverse from the original position in the nail. Class II Zimmer Biomet, Inc.
Oct 2, 2018 Affixus Hip Fracture Nail 130 Deg 10x165mm, Item Number 816810165 The Aff... The set screw is not able to advance or reverse from the original position in the nail. Class II Zimmer Biomet, Inc.
Oct 2, 2018 Affixus Hip Fracture Nail 125 Deg 12x165mm, Item Number 816712165 The Aff... The set screw is not able to advance or reverse from the original position in the nail. Class II Zimmer Biomet, Inc.
Sep 21, 2018 StageOne Hip, Models 431207 & 431209Usage: Product Usage: The single-us... There is a potential for comingling of the 43MM and 51 MM molds Class II Zimmer Biomet, Inc.
Aug 22, 2018 Biomet Microfixation RapidFlap System 16MM RapidFlap SpinDown Clamp Ref N... Spin Down RapidFlap nut that interfaces with the outer plate was assembled incorrectly. Class II Zimmer Biomet, Inc.
Aug 22, 2018 Biomet Microfixation RapidFlap System 12mm SpinDown Clamp, sterile Ref Numbe... Spin Down RapidFlap nut that interfaces with the outer plate was assembled incorrectly. Class II Zimmer Biomet, Inc.
Aug 22, 2018 Biomet Microfixation RapidFlap System, 12MM RapidFlap SpinDown Clamp, 12 Pac... Spin Down RapidFlap nut that interfaces with the outer plate was assembled incorrectly. Class II Zimmer Biomet, Inc.
Aug 22, 2018 Biomet Microfixation RapidFlap System 20MM RapidFlap SpinDown Clamp, 12 Pac... Spin Down RapidFlap nut that interfaces with the outer plate was assembled incorrectly. Class II Zimmer Biomet, Inc.
Aug 22, 2018 Biomet Microfixation RapidFlap System 20MM RapidFlap SpinDown Clamp Ref N... Spin Down RapidFlap nut that interfaces with the outer plate was assembled incorrectly. Class II Zimmer Biomet, Inc.
Aug 22, 2018 Biomet Microfixation RapidFlap System 16MM RapidFlap SpinDown Clamp, 12 Pa... Spin Down RapidFlap nut that interfaces with the outer plate was assembled incorrectly. Class II Zimmer Biomet, Inc.
Aug 8, 2018 Affixus Hip Fracture Nail Right 125 13 mm x 360 mm, Item Number 814313360 ... There were complaints indicating that when the product was opened in surgery, the sterile packagi... Class II Zimmer Biomet, Inc.
Aug 8, 2018 Affixus Hip Fracture Nail Left 125 9 mm x 320 mm, Item Number 814409320 Prod... There were complaints indicating that when the product was opened in surgery, the sterile packagi... Class II Zimmer Biomet, Inc.
Aug 8, 2018 Affixus Hip Fracture Nail 125 9 mm x 165 mm, Item Number 816709165 Product... There were complaints indicating that when the product was opened in surgery, the sterile packagi... Class II Zimmer Biomet, Inc.
Aug 8, 2018 Affixus Hip Fracture Nail Right 125 13 mm x 300 mm, Item Number 814313300 ... There were complaints indicating that when the product was opened in surgery, the sterile packagi... Class II Zimmer Biomet, Inc.
Aug 8, 2018 Affixus Hip Fracture Nail Left 130 9 mm x 360 mm, Item Number 814609360 ... There were complaints indicating that when the product was opened in surgery, the sterile packagi... Class II Zimmer Biomet, Inc.
Aug 8, 2018 Affixus Hip Fracture Nail Right 125 9 mm x 300 mm, Item Number 814309300 P... There were complaints indicating that when the product was opened in surgery, the sterile packagi... Class II Zimmer Biomet, Inc.
Aug 8, 2018 Affixus Hip Fracture Nail Right 130 11 mm x 360 mm, Item Number 814511360 ... There were complaints indicating that when the product was opened in surgery, the sterile packagi... Class II Zimmer Biomet, Inc.
Aug 8, 2018 Affixus Hip Fracture Nail Left 125 9 mm x 260 mm, Item Number 814409260 Pr... There were complaints indicating that when the product was opened in surgery, the sterile packagi... Class II Zimmer Biomet, Inc.
Aug 8, 2018 Affixus Hip Fracture Nail Right 125 9 mm x 440 mm, Item Number 814309440 P... There were complaints indicating that when the product was opened in surgery, the sterile packagi... Class II Zimmer Biomet, Inc.
Aug 8, 2018 Affixus Hip Fracture Nail Right 125 11 mm x 420 mm, Item Number 814311420 ... There were complaints indicating that when the product was opened in surgery, the sterile packagi... Class II Zimmer Biomet, Inc.
Aug 8, 2018 Affixus Hip Fracture Nail Left 130 15 mm x 360 mm, Item Number 814615360 P... There were complaints indicating that when the product was opened in surgery, the sterile packagi... Class II Zimmer Biomet, Inc.
Aug 8, 2018 Affixus Hip Fracture Nail Left 125 9 mm x 300 mm, Item Number 814409300 Pr... There were complaints indicating that when the product was opened in surgery, the sterile packagi... Class II Zimmer Biomet, Inc.
Aug 8, 2018 Affixus Hip Fracture Nail Right 125 9 mm x 340 mm, Item Number 814309340 P... There were complaints indicating that when the product was opened in surgery, the sterile packagi... Class II Zimmer Biomet, Inc.
Aug 8, 2018 Affixus Hip Fracture Nail Left 125 11 mm x 260 mm, Item Number 814411260 Pro... There were complaints indicating that when the product was opened in surgery, the sterile packagi... Class II Zimmer Biomet, Inc.
Aug 8, 2018 Affixus Hip Fracture Nail Right 125 13 mm x 260 mm, Item Number 814313260 ... There were complaints indicating that when the product was opened in surgery, the sterile packagi... Class II Zimmer Biomet, Inc.
Aug 8, 2018 Affixus Hip Fracture Nail - Left 125 11mm x 340mm, Item Number 814411340 Pro... There were complaints indicating that when the product was opened in surgery, the sterile packagi... Class II Zimmer Biomet, Inc.
Aug 8, 2018 Affixus Hip Fracture Nail Left 130 11 mm x 380 mm, Item Number 814611380 ... There were complaints indicating that when the product was opened in surgery, the sterile packagi... Class II Zimmer Biomet, Inc.
Aug 8, 2018 Affixus Hip Fracture Nail Right 125 13 mm x 280 mm, Item Number 814313280 ... There were complaints indicating that when the product was opened in surgery, the sterile packagi... Class II Zimmer Biomet, Inc.
Aug 8, 2018 Affixus Hip Fracture Nail Right 130 11 mm x 400 mm, Item Number 814511400 ... There were complaints indicating that when the product was opened in surgery, the sterile packagi... Class II Zimmer Biomet, Inc.
Aug 8, 2018 Affixus Hip Fracture Nail 125 11mm x 180mm, Item Number 814311180 Product Us... There were complaints indicating that when the product was opened in surgery, the sterile packagi... Class II Zimmer Biomet, Inc.
Aug 8, 2018 Affixus Hip Fracture Nail Left 130 11 mm x 400 mm, Item Number 814611400 P... There were complaints indicating that when the product was opened in surgery, the sterile packagi... Class II Zimmer Biomet, Inc.
Aug 8, 2018 Affixus Hip Fracture Nail Right 125 13 mm x 440 mm, Item Number 814313440 ... There were complaints indicating that when the product was opened in surgery, the sterile packagi... Class II Zimmer Biomet, Inc.
Aug 8, 2018 Affixus Hip Fracture Nail Left 125 13 mm x 340 mm, Item Number 814413340 P... There were complaints indicating that when the product was opened in surgery, the sterile packagi... Class II Zimmer Biomet, Inc.
Aug 8, 2018 Affixus Hip Fracture Nail Left 125 11 mm x 320 mm, Item Number 814411320 Pro... There were complaints indicating that when the product was opened in surgery, the sterile packagi... Class II Zimmer Biomet, Inc.
Aug 8, 2018 Affixus Hip Fracture Nail Right 125 9 mm x 380 mm, Item Number 814309380 P... There were complaints indicating that when the product was opened in surgery, the sterile packagi... Class II Zimmer Biomet, Inc.
Aug 8, 2018 Affixus Hip Fracture Nail Right 125 11 mm x 340 mm, Item Number 814311340 ... There were complaints indicating that when the product was opened in surgery, the sterile packagi... Class II Zimmer Biomet, Inc.
Aug 8, 2018 Affixus Hip Fracture Nail Right 125 11 mm x 360 mm, Item Number 814311360 ... There were complaints indicating that when the product was opened in surgery, the sterile packagi... Class II Zimmer Biomet, Inc.
Aug 8, 2018 Affixus Hip Fracture Nail Right 125 11 mm x 380 mm, Item Number 814311380 ... There were complaints indicating that when the product was opened in surgery, the sterile packagi... Class II Zimmer Biomet, Inc.
Aug 8, 2018 Affixus Hip Fracture Nail 125 9 mm x 180 mm, Item Number 814309180 Produc... There were complaints indicating that when the product was opened in surgery, the sterile packagi... Class II Zimmer Biomet, Inc.
Aug 8, 2018 Affixus Hip Fracture Nail Right 130 9 mm x 320 mm, Item Number 814509320 P... There were complaints indicating that when the product was opened in surgery, the sterile packagi... Class II Zimmer Biomet, Inc.
Aug 8, 2018 Affixus Hip Fracture Nail Left 125 13 mm x 360 mm, Item Number 814413360 P... There were complaints indicating that when the product was opened in surgery, the sterile packagi... 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.