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Vehicle Recalls320,000+ NHTSA safety recalls Browse VehiclesEvery make, model and year Complaints2.1M+ consumer safety complaints TSBs4.7M technical service bulletins VIN LookupDecode any vehicle VIN instantly OBD Codes12,000+ diagnostic trouble codes Fuel EconomyEPA MPG data for all vehicles Safety Ratings11,700+ NHTSA crash test ratings Investigations5,300+ NHTSA defect investigations StatisticsRecall trends & safety analysis Compare VehiclesTwo vehicles side by side

Consumer Safety

Product Safety9,700+ CPSC product recalls Food Safety28,600+ FDA food recalls Pet Safety1.3M FDA animal adverse events Drug Safety17,500+ FDA drug recalls Device Safety38,400+ FDA device recalls Workplace Safety102,900+ OSHA injury reports Brand HistoryRecall lookup by company

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Browse Device Recalls

1,515 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 1,515 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 1,515 FDA device recalls.

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DateProductReasonClassFirm
Feb 28, 2017 Segmental fluted stem, 19x190mm str, Sterile, Knee joint femorotibial meta/... Zimmer Biomet Inc. initiated a field action on 02/28/2017 for sterile-packaged implants packaged ... Class II Zimmer Biomet, Inc.
Feb 28, 2017 Segmental fluted stem, 18x190mm str, Sterile, Knee joint femorotibial meta/... Zimmer Biomet Inc. initiated a field action on 02/28/2017 for sterile-packaged implants packaged ... Class II Zimmer Biomet, Inc.
Feb 28, 2017 Xl por st 24.0x220mm, bowed, Sterile, Rod, fixation, intramedullary and acc... Zimmer Biomet Inc. initiated a field action on 02/28/2017 for sterile-packaged implants packaged ... Class II Zimmer Biomet, Inc.
Feb 28, 2017 Segmental malefemale taper, 220mm, Sterile, Knee joint femorotibial meta/po... Zimmer Biomet Inc. initiated a field action on 02/28/2017 for sterile-packaged implants packaged ... Class II Zimmer Biomet, Inc.
Feb 28, 2017 Fem IM Nail 16mmdx38cm, Sterile, Rod, fixation, intramedullary and accessor... Zimmer Biomet Inc. initiated a field action on 02/28/2017 for sterile-packaged implants packaged ... Class II Zimmer Biomet, Inc.
Feb 28, 2017 Fem IM Nail 14mmdx48cm left, Sterile, Rod, fixation, intramedullary and acc... Zimmer Biomet Inc. initiated a field action on 02/28/2017 for sterile-packaged implants packaged ... Class II Zimmer Biomet, Inc.
Feb 28, 2017 Segmental fluted stem, 17x190mm str, Sterile, Knee joint femorotibial meta/... Zimmer Biomet Inc. initiated a field action on 02/28/2017 for sterile-packaged implants packaged ... Class II Zimmer Biomet, Inc.
Feb 28, 2017 Por fullct fem st 17x200mm, Sterile, Zimmer Biomet Inc. initiated a field action on 02/28/2017 for sterile-packaged implants packaged ... Class II Zimmer Biomet, Inc.
Feb 27, 2017 MEDTECH ROSA Brain 3.0 The device is intended for the spatial positioning an... Unapproved change made by the supplier. Class II Zimmer Biomet, Inc.
Feb 27, 2017 MEDTECH ROSA Spine 1.0.2 The device is intended for the spatial positioning ... Unapproved change made by the supplier. Class II Zimmer Biomet, Inc.
Feb 17, 2017 various polyethylene implants Custom parts Product Usage: Custom Endotoxin levels higher than process maximum limits were discovered in the identified polyethylen... Class II Zimmer Biomet, Inc.
Feb 17, 2017 various polyethylene implants Extremities, Shoulders and Elbows BioModular... Endotoxin levels higher than process maximum limits were discovered in the identified polyethylen... Class II Zimmer Biomet, Inc.
Feb 17, 2017 various polyethylene implants Hips Active Articulation ArComXL Bearings A... Endotoxin levels higher than process maximum limits were discovered in the identified polyethylen... Class II Zimmer Biomet, Inc.
Feb 17, 2017 various polyethylene implants BIO PLUG 10MM Product Usage: Non-weig... Endotoxin levels higher than process maximum limits were discovered in the identified polyethylen... Class II Zimmer Biomet, Inc.
Feb 17, 2017 various polyethylene implants Knees Revision Tibial Tray Systems Oxford P... Endotoxin levels higher than process maximum limits were discovered in the identified polyethylen... Class II Zimmer Biomet, Inc.
Feb 17, 2017 various polyethylene implants Sports Med Repicci II Tibial Components P... Endotoxin levels higher than process maximum limits were discovered in the identified polyethylen... Class II Zimmer Biomet, Inc.
Feb 14, 2017 Orthosize Templating Version 1.2.6 Echo Bi-Metric Hip Stem Digital Templates... Digital templates were created with the incorrect files. Class II Zimmer Biomet, Inc.
Jan 10, 2017 1.5mm System, Cranio-maxillofacial Bone Screws 1.5 x 4mm HT SD X-DR Screw, B... The identification of the devices was non-conforming with off-centered slots and the no-go gage s... Class II Zimmer Biomet, Inc.
Jan 4, 2017 Vanguard Total Knee System Vanguard Open Box Femoral Components Item Numb... packaging of some femoral components was incorrectly labeled as either smaller or larger and/or a... Class II Zimmer Biomet, Inc.
Dec 20, 2016 Comprehensive Reverse Shoulder System Humeral Tray Model 115340 Higher than anticipated rate of fracturing due to design. Risk of revision surgery due to fractu... Class I Zimmer Biomet, Inc.
Dec 19, 2016 Active Articulation ArComXL Polyethylene Bearings Active Articulation ArComX... Product complaints indicated that the part and lot numbers on the packaging differed from the phy... Class II Zimmer Biomet, Inc.
Dec 19, 2016 RingLoc ArComXL Highly Crosslinked Polyethylene Liners ArComXL High Wall +3m... Product complaints indicated that the part and lot numbers on the packaging differed from the phy... Class II Zimmer Biomet, Inc.
Dec 16, 2016 Orthopedic Salvage System (OSS) 9cm prosthesis, knee, femorotibial, constrai... labeling for specific lots of the Standard OSS Modular Proximal Tibia incorrectly identifies the ... Class II Zimmer Biomet, Inc.
Dec 15, 2016 Vanguard Total Knee, PUNCH THRU TRL PLATES, 63 MM Item No: 32-487261, 67 MM I... Zimmer Biomet is conducting a medical device recall for ARCOS & TPRLC broaches and rasps due to p... Class II Zimmer Biomet, Inc.
Dec 6, 2016 Oxford Fixed Lateral Bearing Size F Right, Part Number 154375 Lot 744260, Ste... Zimmer Biomet is initiating a removal of a single lot of Oxford Fixed Lateral Bearings due to mis... Class II Zimmer Biomet, Inc.
Oct 11, 2016 ROSA Brain, 3.0.0 The device is intended for the spatial positioning and ori... Complaint of the head holder connector locking up mechanically when tightened. Class II Zimmer Biomet, Inc.
Sep 28, 2016 Zimmer¿ Gender Solutions" Patellofemoral Joint Prosthesis Milling Handpiece Complaints have been reported that the handpiece is inoperable. The investigation found that the ... Class II Zimmer Biomet, Inc.
Sep 14, 2016 BIOMET 3i LOW PROFILE ABUTMENT QUICKBRIDGE An endosseous dental implant abut... A limited number of product pouches may not have been sealed during packaging. Class II Biomet 3i, LLC
Sep 14, 2016 BIOMET 3i LOW PROFILE ABUTMENT NON-HEXED TEMPORARY CYLINDER An endosseous ... A limited number of product pouches may not have been sealed during packaging. Class II Biomet 3i, LLC
Sep 14, 2016 BIOMET 3i LOW PROFILE 30¿ ABUTMENT 3.4MM(D) X 3MM(H) An endosseous dental im... A limited number of product pouches may not have been sealed during packaging. Class II Biomet 3i, LLC
Sep 14, 2016 BIOMET 3i CERTAIN LOW PROFILE ABUTMENT 3.4MM(D) X 2MM(H) An endosseous denta... A limited number of product pouches may not have been sealed during packaging. Class II Biomet 3i, LLC
Sep 14, 2016 BIOMET 3i CERTAIN LOW PROFILE 30¿ ABUTMENT 4.1MM(D) X 3MM(H) An endosseous d... A limited number of product pouches may not have been sealed during packaging. Class II Biomet 3i, LLC
Sep 14, 2016 BIOMET 3i LOW PROFILE ABUTMENT (NON-HEXED) TRANSFER IMPRESSION COPING An e... A limited number of product pouches may not have been sealed during packaging. Class II Biomet 3i, LLC
Sep 14, 2016 BIOMET 3i CERTAIN LOW PROFILE 17¿ ABUTMENT 4.1MM(D) X 4MM(H) An endosseous d... A limited number of product pouches may not have been sealed during packaging. Class II Biomet 3i, LLC
Sep 14, 2016 BIOMET 3i CERTAIN LOW PROFILE ONE-PIECE ABUTMENT 4.1MM(D) X 1MM(H) An endoss... A limited number of product pouches may not have been sealed during packaging. Class II Biomet 3i, LLC
Sep 14, 2016 BIOMET 3i LOW PROFILE ABUTMENT HEXED TEMPORARY CYLINDER An endosseous dent... A limited number of product pouches may not have been sealed during packaging. Class II Biomet 3i, LLC
Sep 14, 2016 BIOMET 3i LOW PROFILE ABUTMENT HEALING CAP An endosseous dental implant abut... A limited number of product pouches may not have been sealed during packaging. Class II Biomet 3i, LLC
Sep 14, 2016 BIOMET 3i LOW PROFILE 30¿ ABUTMENT 3.4MM(D) X 5MM(H) An endosseous dental im... A limited number of product pouches may not have been sealed during packaging. Class II Biomet 3i, LLC
Sep 14, 2016 BIOMET 3i CERTAIN LOW PROFILE ONE-PIECE ABUTMENT 3.4MM(D) X 4MM(H) An endoss... A limited number of product pouches may not have been sealed during packaging. Class II Biomet 3i, LLC
Sep 14, 2016 BIOMET 3i LOW PROFILE ABUTMENT (HEXED) PICK-UP IMPRESSION COPING An endosseo... A limited number of product pouches may not have been sealed during packaging. Class II Biomet 3i, LLC
Sep 14, 2016 BIOMET 3i CERTAIN LOW PROFILE 30¿ ABUTMENT 4.1MM(D) X 5MM(H) An endosseous d... A limited number of product pouches may not have been sealed during packaging. Class II Biomet 3i, LLC
Sep 14, 2016 BIOMET 3i CERTAIN LOW PROFILE 17¿ ABUTMENT 3.4MM(D) X 4MM(H) An endosseous d... A limited number of product pouches may not have been sealed during packaging. Class II Biomet 3i, LLC
Sep 14, 2016 BIOMET 3i LOW PROFILE ONE-PIECE ABUTMENT 4.1MM(D) X 4MM(H) An endosseous den... A limited number of product pouches may not have been sealed during packaging. Class II Biomet 3i, LLC
Sep 14, 2016 BIOMET 3i CERTAIN LOW PROFILE 17¿ ABUTMENT 3.4MM(D) X 2MM(H) An endosseous d... A limited number of product pouches may not have been sealed during packaging. Class II Biomet 3i, LLC
Sep 14, 2016 BIOMET 3i LOW PROFILE ABUTMENT NON-HEXED PREFORMANCE TEMPORARY CYLINDER An... A limited number of product pouches may not have been sealed during packaging. Class II Biomet 3i, LLC
Sep 14, 2016 BIOMET 3i CERTAIN LOW PROFILE ONE-PIECE ABUTMENT 4.1MM(D) X 4MM(H) An endoss... A limited number of product pouches may not have been sealed during packaging. Class II Biomet 3i, LLC
Sep 14, 2016 BIOMET 3i CERTAIN LOW PROFILE 30¿ ABUTMENT 3.4MM(D) X 5MM(H) An endosseous d... A limited number of product pouches may not have been sealed during packaging. Class II Biomet 3i, LLC
Sep 14, 2016 BIOMET 3i LOW PROFILE ONE-PIECE ABUTMENT 4.1MM(D) X 2MM(H) An endosseous den... A limited number of product pouches may not have been sealed during packaging. Class II Biomet 3i, LLC
Sep 14, 2016 BIOMET 3i LOW PROFILE ONE-PIECE ABUTMENT 4.1MM(D) X 1MM(H) An endosseous den... A limited number of product pouches may not have been sealed during packaging. Class II Biomet 3i, LLC
Sep 14, 2016 BIOMET 3i CERTAIN LOW PROFILE ABUTMENT 4.1MM(D) X 2MM(H) An endosseous denta... A limited number of product pouches may not have been sealed during packaging. Class II Biomet 3i, LLC

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.