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Browse Device Recalls

16 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 16 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 16 FDA device recalls.

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DateProductReasonClassFirm
May 19, 2025 PRIMA 2MM ECCENTRICAL ADAPTOR WITH SCREW REF: 1367.15.702, Sterile There is the potential that the eccentrical adaptor with screw, black laser marking, use to ident... Class II Limacorporate S.p.A
May 19, 2025 PRIMA 4MM ECCENTRICAL ADAPTOR WITH SCREW, REF:1367.15.704, Sterile There is the potential that the eccentrical adaptor with screw, black laser marking, use to ident... Class II Limacorporate S.p.A
Oct 2, 2024 TEMA Elbow - Axle Small REF 1590.15.010 TEMA Elbow - Axle Large REF 1590.1... Due to a potential difference in mechanical behavior between the implanted device and tool(s) use... Class II Limacorporate S.p.A
Oct 27, 2023 PHYSICA HPS Tibial Liner #6 H10 REF 6539.54.610 Due to incorrect product labeling Class II Limacorporate S.p.A
Aug 29, 2023 PRIMA TT Glenoid Monoblock/Modular reverse TT baseplates: Description/Product... Potential for baseplate peripheral holes to be out of specification due to a manufacturing issue,... Class II Limacorporate S.p.A
May 30, 2023 REF 1975.14.500, Prima TT Genoid Monoblock Reverse TT Baseplate, STERILE R Due to manufacturing issue, their is a potential for peripheral holes to be out of specification. Class II Limacorporate S.p.A
May 30, 2023 REF 1975.14.800, Prima TT Genoid Modular Reverse TT Baseplate, Sterile R Due to manufacturing issue, their is a potential for peripheral holes to be out of specification. Class II Limacorporate S.p.A
Feb 21, 2023 SMR TT Hybrid glenoid Std - Peg S, REF: 1379.59.210 Shoulder glenoid fossa prosthesis was manufactured without tantalum markers so in the absence of ... Class II Limacorporate S.p.A
Jan 25, 2023 TEMA Axle Small, REF 1590.15.010 (additional information is pending receipt ... Due to the incorrect component, that is not cleared to be marketed in the U.S., being included in... Class II Limacorporate S.p.A
Oct 1, 2021 REF 8420.15.010, Bone Screw/Vite - Ti6AI4V, Self Tapping/Autofilettante, Dia=... There is a potential that the length of bone screws identified on labeling may not correspond to... Class II Limacorporate S.p.A
Oct 1, 2021 REF 8420.15.020, Bone Screw/Vite - Ti6AI4V, Self Tapping/Autofilettante, Dia=... There is a potential that the length of bone screws identified on labeling may not correspond to... Class II Limacorporate S.p.A
Sep 8, 2017 Delta Cup Beater  Positioner - Aligner, model # 9057.20.555 Used during i... An internal analysis on complaints received indicated that the welding process may have been perf... Class II Limacorporate S.p.A
Jul 21, 2016 SMR allen wrench 5 mm, product code 9013.50.210 Product found to be dimensionally non-conforming (slightly over dimensioned on the diameter of th... Class II Limacorporate S.p.A
Apr 8, 2016 SMR glenosphere impactor/extractor; Used to implant the glenosphere in the SM... Complaints of intra-operative breakage of the glenosphere impactors/extractors. Class II Limacorporate S.p.A
Aug 14, 2015 SMR Shoulder/Spalla Trial Humeral Head diameter .42 mm, REF 9013.22.425; SMR ... The dimensions of the mating features of the recalled products are out of specification causing t... Class II Limacorporate S.p.A
Aug 14, 2015 SMR Shoulder/Spalla Trial Heads ECC .4 mm Adaptor, REF 9013.30.021; SMR Shoul... The dimensions of the mating features of the recalled products are out of specification causing t... Class II Limacorporate S.p.A

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.