Vehicle Safety
Recalls Search 320,000+ NHTSA safety recalls Complaints 2.1M+ consumer safety complaints TSBs 4.7M technical service bulletins VIN Lookup Decode any vehicle VIN instantly OBD Codes 12,000+ diagnostic trouble codes Fuel Economy EPA MPG data for all vehicles Statistics Recall trends & safety analysis
Consumer Safety
Product Safety 9,700+ CPSC product recalls Food Safety 28,600+ FDA food recalls Pet Safety 1.3M FDA animal adverse events Drug Safety 17,500+ FDA drug recalls Device Safety 38,400+ FDA device recalls Workplace Safety 102,900+ OSHA injury reports
Infrastructure
Bridge Safety 624,000 bridge inspections Aviation Safety 30,000+ NTSB aviation events Dam Safety 92,600 dam safety records Water Safety 433,000+ public water systems Railroad Safety 438,000+ rail crossings Pipeline Safety 8,800+ pipeline incidents
Public Health
Nursing Homes 14,700 CMS rated facilities Environmental 80,000+ hazardous sites & releases

Browse Device Recalls

32 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 32 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 32 FDA device recalls.

Clear
DateProductReasonClassFirm
Mar 11, 2024 Identity Imprint PS Tibial Tray Size 4: Lot 540287 Size 5 Tibial Tray from Lot 508287 was packaged in a Size 4 box from Lot 540287. It was confirmed... Class II Conformis, Inc.
Jun 16, 2023 CONFORMIS HIP-SCREW-6.5MM X 25MM, STERILE EO 30mm screws were labeled as 25mm screws. Class II Conformis, Inc.
Nov 14, 2022 iTotal Identity Impactor Handle, Model No. 1080-212/ED-07827 REV AE Loctite thread locker (epoxy) may not have been applied to the screw that is part of the handle. ... Class II Conformis, Inc.
Feb 22, 2022 iTotal Identity Posterior Stabilised (PS) Knee Replacement System Model Numb... Incorrect tibial base plate implant packaged in kit Class II Conformis, Inc.
Sep 21, 2020 iTotal Hip Replacement System, Model number HAA-050-D020-020102 The Confor... Incorrect hip components were provided in kits. Class II Conformis, Inc.
Jul 20, 2020 Conformis iTotal Cruciate Retaining (CR) Knee Replacement System- Orthopedic ... Outer box labels for kit 0469247 correct, however the boxes contained the implants and jigs for 0... Class II Conformis, Inc.
Feb 3, 2020 iTotal CR Knee Replacement System, Model No. TCR-121-1111-010102, (ITOTAL CR ... A limited number of tibial trays were labeled with an incorrect serial number and were delivered ... Class II Conformis, Inc.
Feb 3, 2020 iTotal PS Knee Replacement System, Model No. TPS-111-1111-010101, (ITOTAL PS ... A limited number of tibial trays were labeled with an incorrect serial number and were delivered ... Class II Conformis, Inc.
Oct 25, 2019 iTotal CR Knee Replacement System Model Number: TCR-111-1111-010102 - Produc... Medial and lateral polyethylene inserts did not securely fit into the cobalt chrome tray implant. Class II Conformis, Inc.
Aug 22, 2019 iTotal Hip Replacement System, Model HBS-033-0013-020101, Size 13 Hip-Patient... Two femoral stems, sizes 13 and 15, were erroneously switched and packed in each other's packaging. Class II Conformis, Inc.
Aug 22, 2019 iTotal Hip Replacement System, Model HBS-033-0015-020101, Size 15 Hip-Patient... Two femoral stems, sizes 13 and 15, were erroneously switched and packed in each other's packaging. Class II Conformis, Inc.
Mar 29, 2019 Conformis iTotal Hip Replacement System: HBS-033-00xx-020101, (HIP-PATIENT S... Discrepancy of 3mm between the values displayed and approved by surgeons in iViews as the neck/he... Class II Conformis, Inc.
Mar 29, 2019 Conformis iTotal Hip Replacement System: HBS-033-00xx-010101, (HIP-PATIENT S... Discrepancy of 3mm between the values displayed and approved by surgeons in iViews as the neck/he... Class II Conformis, Inc.
Jan 4, 2019 iTotal Posterior Stabilized (PS) Knee Replacement System, Catalog Number TPS-... The labeling of the boxes and sterile pouches did not match the contents. Class II Conformis, Inc.
Dec 3, 2018 iTotal CR Total Knee Replacement System, TCR-121-1111 (Catalog No.) / TCR-121... The kits were prepared with incorrect patient ID labels and may contain incorrect components. Class II Conformis, Inc.
Oct 16, 2018 iTotal Hip Replacement System, Total Hip Replacement System, Catalog Number H... The stage 1 and 2 reamer instruments used to prepare fixation for the cup in the acetabulum had a... Class II Conformis, Inc.
Jul 24, 2017 Total Knee Replacement , Catalog/Model # TPS-111-1111, UDI: +M572TPS111111102... Implant kit mislabeled Class II ConforMIS, Inc.
Oct 31, 2016 ConFORMIS ITOTAL PS-IPOLYIMPLANT KIT-RIGHT Catalog Number:TPS-111-1111 The... iView report displayed femoral cut measurements in the incorrect unit of measure (inches vs. mm). Class II ConforMIS, Inc.
Oct 18, 2016 ConforMIS iTotal Cruciate Retaining (CR) Knee Replacement System, Sterile Ca... Mislabeled: incorrect serial number on the F4 A/P cut guide iJig. Class II ConforMIS, Inc.
Jan 28, 2016 Conformis iTotal Cruciate Retaining (CR) Knee Replacement System Model: TCR-... Incorrect femoral component distributed Class II ConforMIS, Inc.
Aug 31, 2015 ConFormis iDUO G2, Right Lateral Catalog Number: M5723INT0600240 (US) ... May contain small amounts of ethylene glycol residue Class II ConforMIS, Inc.
Aug 31, 2015 ConForMIS Unicondylar Knee Replacement System iUNI G2, Left Medial Catalog ... May contain small amounts of ethylene glycol residue Class II ConforMIS, Inc.
Aug 31, 2015 ConFormis iTotal CR Knee Replacement System- ITOTAL CR - IPOLY - IMPLANT KIT... May contain small amounts of ethylene glycol residue Class II ConforMIS, Inc.
Aug 31, 2015 ConForMIS iTotal CR (Cruciate Retaining) Knee Replacement System-iTOTAL CR, L... May contain small amounts of ethylene glycol residue Class II ConforMIS, Inc.
Aug 31, 2015 ConFormis iTotal Posterior Stabilized Knee Replacement System- ITOTAL PS-IP... May contain small amounts of ethylene glycol residue Class II ConforMIS, Inc.
Aug 31, 2015 ConForMIS iDuo Knee Bicompartmental Knee Replacement System , iDUO G2, Right ... May contain small amounts of ethylene glycol residue Class II ConforMIS, Inc.
Aug 31, 2015 ConForMIS iDuo Bicompartmental Knee Replacement System iDUO G2, Left Lateral... May contain small amounts of ethylene glycol residue Class II ConforMIS, Inc.
Aug 31, 2015 ConForMIS iUNI Unicondylar Knee Replacement System iUNI G2, Right Lateral ... May contain small amounts of ethylene glycol residue Class II ConforMIS, Inc.
Aug 31, 2015 ConForMIS iUni Unicondylar Knee Replacement System- iUNI G2, Right Medial C... May contain small amounts of ethylene glycol residue Class II ConforMIS, Inc.
Aug 31, 2015 ConFormis iTotal CR Knee Replacement System- iTOTAL CR, Right Knee Catalog ... May contain small amounts of ethylene glycol residue Class II ConforMIS, Inc.
Aug 31, 2015 ConForMIS iUni Unicondylar Knee Replacement System: iUNI G2, Left Lateral ... May contain small amounts of ethylene glycol residue Class II ConforMIS, Inc.
Nov 19, 2014 Conformis iTotal CR G2 Knee Replacement System Catalog/Model #: M57250600010... Incorrect serial number of tibial inserts packaged in tray may result in inserts not fitting Class II ConforMIS, 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.