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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

2,560 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,560 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 2,560 FDA device recalls in IN.

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DateProductReasonClassFirm
Dec 21, 2023 FLEXSelect 5/16" Amber Latex Elastics-Intended use is orthodontics, braces, t... Latex elastic bands were labeled as non-latex elastic bands, an allergic rx can occur due to pati... Class II G & H Wire Company
Dec 7, 2023 MINC+ Benchtop Incubator, Reference Part Number (RPN) K-MINC-2000, Order Numb... The MINC+ device is susceptible to losing temperature control of electrostatic discharge (static ... Class II Cook Medical Llc
Nov 2, 2023 Biolox Ceramic Option Head Zimmer 12/14 40mm -3, Item Number 00-8777-040-01 One product complaint was received reporting that there was an incorrect adapter in the packaging... Class II Biomet, Inc.
Nov 2, 2023 Biolox Ceramic Option Head Zimmer 12/14 40mm +0, Item Number 00-8777-040-02 One product complaint was received reporting that there was an incorrect adapter in the packaging... Class II Biomet, Inc.
Oct 9, 2023 Compress Device Segmental Anchor Plug, 24 MM-For Correction of revision of un... Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the d... Class II Biomet, Inc.
Oct 9, 2023 Compress Device Short Anchor Plug, 18 MM-For Correction of revision of unsucc... Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the d... Class II Biomet, Inc.
Oct 9, 2023 Compress Device Segmental Anchor Plug, 16 MM-For Correction of revision of un... Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the d... Class II Biomet, Inc.
Oct 9, 2023 Compress Device Segmental Anchor Plug, 22 MM-For Correction of revision of un... Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the d... Class II Biomet, Inc.
Oct 9, 2023 Compress Device Short Anchor Plug, 20 MM-For Correction of revision of unsucc... Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the d... Class II Biomet, Inc.
Oct 9, 2023 Compress Device Short Anchor Plug, 23 MM-For Correction of revision of unsucc... Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the d... Class II Biomet, Inc.
Oct 9, 2023 Compress Device Short Anchor Plug, 10 MM-Correction of revision of unsuccessf... Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the d... Class II Biomet, Inc.
Oct 9, 2023 Compress Device Short Anchor Plug, 22 MM-For Correction of revision of unsucc... Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the d... Class II Biomet, Inc.
Oct 9, 2023 Compress Device Segmental Anchor Plug, 12 MM -For Correction of revision of u... Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the d... Class II Biomet, Inc.
Oct 9, 2023 Compress Device Short Anchor Plug, 16 MM- Correction of revision of unsuccess... Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the d... Class II Biomet, Inc.
Oct 9, 2023 Compress Device Segmental Anchor Plug, 10 MM-For Correction of revision of un... Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the d... Class II Biomet, Inc.
Oct 9, 2023 Compress Device Segmental Anchor Plug, 14 MM-For Correction of revision of un... Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the d... Class II Biomet, Inc.
Oct 9, 2023 Compress Device Short Anchor Plug, 12 MM-For Correction of revision of unsucc... Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the d... Class II Biomet, Inc.
Oct 9, 2023 Compress Device Segmental Anchor Plug, 20 MM-For Correction of revision of un... Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the d... Class II Biomet, Inc.
Oct 9, 2023 Compress Device Segmental Anchor Plug, 18 MM-For Correction of revision of un... Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the d... Class II Biomet, Inc.
Oct 9, 2023 Compress Device Short Anchor Plug, 28 MM-For Correction of revision of unsucc... Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the d... Class II Biomet, Inc.
Oct 9, 2023 Compress Device Short Anchor Plug, 14 MM-For Correction of revision of unsucc... Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the d... Class II Biomet, Inc.
Oct 9, 2023 Compress Device Short Anchor Plug, 24 MM-For Correction of revision of unsucc... Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the d... Class II Biomet, Inc.
Oct 9, 2023 Compress Device Short Anchor Plug, 26 MM-For Correction of revision of unsucc... Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the d... Class II Biomet, Inc.
Oct 3, 2023 Tina-quant D-Dimer Test System, Fibrinogen/Fibrin Degradation Products Assay,... Elevated results were detected with Li-heparin plasma samples when compared to citrated plasma sa... Class II Roche Diagnostics Operations, Inc.
Jul 26, 2023 M/L Taper Hip Prosthesis Extended Offset, Reduced Neck Length, Size 4 (Item N... The outer package labeling and product etch are for a Size 6, however, the implant is a Size 4, a... Class II Zimmer, Inc.
Jun 27, 2023 Zimmer Periarticular Locking Plate (ZPLP) Distal Lateral Femoral Plate 6 hole... Thread form issue of the locking holes in that the locking screws would not properly mate with th... Class II Zimmer, Inc.
May 19, 2023 NexGen Precoat Stemmed Tibial Plate Size 5 Device outer packaging was incorrectly labeled. Class II Zimmer, Inc.
Apr 7, 2023 Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Set, Reference Part ... There were reports from customers that the tracheostomy in the sets and trays is not making a sec... Class I Cook Incorporated
Apr 7, 2023 Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Tray, Reference Part... There were reports from customers that the tracheostomy in the sets and trays is not making a sec... Class I Cook Incorporated
Feb 27, 2023 CoCr Femoral Head, XS, 38/-8, Taper 12/14-Intended to be used as a modular he... Update the compatibility matrix as referred to in the Instructions for Use (IFU) for the CoCr Fem... Class II Zimmer, Inc.
Feb 15, 2023 Attune Posterior (PS) Fixed Bearing (FB) Tibial Insert SZ5 7MM, Part Number 1... The subject product lots are being recalled because they received a higher than specified irradia... Class II DePuy Orthopaedics, Inc.
Feb 15, 2023 Attune Revision Limb Preservation System (LPS) Tibial Insert XSM 26MM, Part N... The subject product lots are being recalled because they received a higher than specified irradia... Class II DePuy Orthopaedics, Inc.
Feb 15, 2023 Attune Revision Limb Preservation System (LPS) Tibial Insert XSM 12MM, Part N... The subject product lots are being recalled because they received a higher than specified irradia... Class II DePuy Orthopaedics, Inc.
Feb 15, 2023 Attune Revision Limb Preservation System (LPS) Tibial Insert SM 12MM, Part Nu... The subject product lots are being recalled because they received a higher than specified irradia... Class II DePuy Orthopaedics, Inc.
Feb 15, 2023 Attune Revision Limb Preservation System (LPS) Tibial Insert XXSM 18MM, Part ... The subject product lots are being recalled because they received a higher than specified irradia... Class II DePuy Orthopaedics, Inc.
Feb 6, 2023 G7 Acetabular System, Dual Mobility Acetabular Liner, 40 mm, Size D, Model Nu... The outer package labeling and product etch are a 40 mm Size D liner, however, the implant is a 3... Class II Biomet, Inc.
Feb 3, 2023 Med-Riser MR600 Patient Lift Risk of boom pivot failing due to the nut securing the boom becoming loose and the bolt to be uns... Class II Med-Mizer, Inc.
Feb 3, 2023 Sit to Stand STS500 Patient Lift Risk of boom pivot failing due to the nut securing the boom becoming loose and the bolt to be uns... Class II Med-Mizer, Inc.
Jan 4, 2023 WishBone Medical Smart Correction Dual Joint Express Struts, external skeleto... Firm identified that user may be unable to adjust the length of the Smart Correction Dual Joint E... Class II Wishbone Medical, Inc.
Dec 29, 2022 (1) Vanguard Knee System PS Open Box Femoral; Right; 60 mm. Intended for knee... Components Incorrectly labeled as either smaller or larger and incorrect side (right/left). Class II Biomet, Inc.
Dec 29, 2022 (1) Vanguard Knee System PS Open Box Femoral; Left; 57.5 mm. Intended for Kne... Components Incorrectly labeled as either smaller or larger and incorrect side (right/left). Class II Biomet, Inc.
Dec 15, 2022 Oxford Partial Knee System, Fixed Lateral Tibial Construct- Intended to repla... Packaged in the incorrect shelf carton. Incorrect shelf carton; outer carton is smaller than th... Class II Biomet, Inc.
Dec 12, 2022 cobas infinity central lab, Material Number 07154003001 A complaint investigation revealed that an incorrect behavior relating to the rejection of orders... Class II Roche Diagnostics Operations, Inc.
Dec 7, 2022 Identity Shoulder System Resection Planer 35mm Resection Planer Two planers were found to be unusable during sawbones shoulder training. Class II Zimmer, Inc.
Dec 6, 2022 NexGen Option Stemmed Tibial Component Size 3, Item Number 00-5986-037-01 Zimmer Biomet is conducting a voluntary medical device recall related to the NexGen Stemmed Optio... Class II Zimmer, Inc.
Dec 6, 2022 NexGen Option Stemmed Tibial Component Size 8, Item Number 00-5986-057-02 Zimmer Biomet is conducting a voluntary medical device recall related to the NexGen Stemmed Optio... Class II Zimmer, Inc.
Dec 6, 2022 NexGen Option Stemmed Tibial Component Size 6, Item Number 00-5986-047-02 Zimmer Biomet is conducting a voluntary medical device recall related to the NexGen Stemmed Optio... Class II Zimmer, Inc.
Dec 6, 2022 NexGen Option Stemmed Tibial Component Size 4, Item Number 00-5986-037-02 Zimmer Biomet is conducting a voluntary medical device recall related to the NexGen Stemmed Optio... Class II Zimmer, Inc.
Dec 6, 2022 NexGen Option Stemmed Tibial Component Size 5, Item Number 00-5986-047-01 Zimmer Biomet is conducting a voluntary medical device recall related to the NexGen Stemmed Optio... Class II Zimmer, Inc.
Dec 6, 2022 NexGen Option Stemmed Tibial Component Size 7, Item Number 00-5986-057-01 Zimmer Biomet is conducting a voluntary medical device recall related to the NexGen Stemmed Optio... Class II Zimmer, 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.