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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
Jan 11, 2016 NKII CSTI Porous Femoral NKII NP Femoral prosthesis, knee, patellofemorotib... LDPE bag containing the implant adheres to the highly polished implant surface. Class II Zimmer Biomet, Inc.
Jan 11, 2016 CPT 12/14 COCR prosthesis, hip, semi-constrained, metal/polymer, porous unce... LDPE bag containing the implant adheres to the highly polished implant surface. Class II Zimmer Biomet, Inc.
Jan 11, 2016 Metasul Head 40, 12/14, SZ M/0 total hip prosthesis - metal femoral heads N... LDPE bag containing the implant adheres to the highly polished implant surface. Class II Zimmer Biomet, Inc.
Jan 11, 2016 VERSYS 7.5 INCH BEADED FC prosthesis, hip, semi-constrained, metal/polymer, ... LDPE bag containing the implant adheres to the highly polished implant surface. Class II Zimmer Biomet, Inc.
Jan 11, 2016 VERSYS 6 INCH BEADED FC 1 prosthesis, hip, semi-constrained, metal/polymer, ... LDPE bag containing the implant adheres to the highly polished implant surface. Class II Zimmer Biomet, Inc.
Jan 11, 2016 NexGen CR-FLEX Option FEM NexGen CR-FLEX Precoat FEM NexGen CR-FLEX Porous ... LDPE bag containing the implant adheres to the highly polished implant surface. Class II Zimmer Biomet, Inc.
Jan 11, 2016 VERSYS 6 INCH BEADED FC 1 VERSYS 6 INCH BEADED FC S VERSYS 8 INCH BEADED FC... LDPE bag containing the implant adheres to the highly polished implant surface. Class II Zimmer Biomet, Inc.
Jan 11, 2016 NexGen Knee CR Porous FEM NexGen Knee CR Precoat FEM prosthesis, knee, pate... LDPE bag containing the implant adheres to the highly polished implant surface. Class II Zimmer Biomet, Inc.
Jan 11, 2016 NexGen LPS-FLEX Option Femoral NexGen LPS-FLEX Precoat Femoral prosthesis, ... LDPE bag containing the implant adheres to the highly polished implant surface. Class II Zimmer Biomet, Inc.
Jan 11, 2016 CPT 12/14 COCR prosthesis, hip, semi-constrained, metal/polymer, porous unce... LDPE bag containing the implant adheres to the highly polished implant surface. Class II Zimmer Biomet, Inc.
Jan 11, 2016 CR Flex GSF Precoat Fem Natural Knee GSF NP Flex Natural Knee GSF POR Flex ... LDPE bag containing the implant adheres to the highly polished implant surface. Class II Zimmer Biomet, Inc.
Jan 11, 2016 NexGen LPS Flex Option Femoral NexGen LPS Flex Precoat Femoral prosthesis, ... LDPE bag containing the implant adheres to the highly polished implant surface. Class II Zimmer Biomet, Inc.
Jan 11, 2016 NexGen Knee CR Option Fem NexGen Knee CR Porous Fem NexGen Knee CR Precoat ... LDPE bag containing the implant adheres to the highly polished implant surface. Class II Zimmer Biomet, Inc.
Dec 9, 2015 Zimmer Universal Locking System 3.5mm Locking Reconstruction Plate Straight ... The product on the package label did not match what was inside the package. The label was for par... Class II Zimmer Biomet, Inc.
Dec 9, 2015 Zimmer Periarticular Locking Plate System 3.5mm Locking Screw 58 mm Length; ... Product on the package label did not match what was inside the package. The label was for part... Class II Zimmer Biomet, Inc.
Nov 17, 2015 Zimmer, Virage OCT Spinal Fixation System, Item Number: 07.01738.001, a post... Zimmer Biomet is initiating a recall of the Virage Occipital Eyelet, as it was found through prod... Class II Zimmer Biomet, Inc.
Oct 29, 2015 Rosa Spine 1.0.2 Stereotaxic Instrument Computer-Assisted Surgical Device Th... A design change was initiated to update ROSA Spine 1.0.2 to version ROSA Spine 1.0.2.16 to resolv... Class II Zimmer Biomet, Inc.
Nov 6, 2014 ROSA Surgical Device 2.5.8, a computer-controlled electromechanical arm to gu... Potential failure of a force feedback sensor that may result in continued movement of an operatin... Class II Zimmer Biomet, Inc.
Sep 5, 2014 ROSA Surgical Device 2.5.8 ROSA Surgical Device is a computer-controlled ele... The software issue described was corrected in the modification to the MXTTOUT controller paramete... Class II Zimmer Biomet, Inc.
Jun 4, 2014 ROSA Surgical Device 2.5.8 It is intended to be used in the operating ro... Software corrections reactivating the cooperative endoscopy mode. Class II Zimmer Biomet, Inc.
Feb 14, 2014 ROSA Surgical Device 2.5.8. It is intended to be used in the operating ro... An undetected shift between the information displayed in the navigation software and the actual p... Class II Zimmer Biomet, Inc.
Dec 18, 2013 ROSA Surgical Device 2.5.8 ROSA Surgical Device is a computer-controlled ele... Possible break in the connector of the Force Sensor. Class II Zimmer Biomet, Inc.
Feb 10, 2013 ROSA Surgical Device 2.5.8 Issue with optional neuro-endoscopy module detected under specific conditions during internal tes... Class II Zimmer Biomet, Inc.
Feb 5, 2013 ROSA Surgical Device 2.5.8 ROSA Surgical Device is a computer-controlled el... Observed instability of the device. Class II Zimmer Biomet, Inc.
Apr 19, 2012 ROSA Surgical Device 2.5.8 ROSA Surgical Device is a computer-controlled ele... Potential failure of the optical distance sensor due to cable disconnection. 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.