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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
Dec 21, 2020 SERF Novae Dual Mobility Cup Insert 47/28- ApeX-LNK Poly Liner. Intended for ... Acetabular Liners have a higher than acceptable oxidation limit, potential for patients to experi... Class II OMNIlife science Inc.
Dec 21, 2020 SERF Novae Dual Mobility Cup Insert 51/28- ApeX-LNK Poly Liner. Intended for ... Acetabular Liners have a higher than acceptable oxidation limit, potential for patients to experi... Class II OMNIlife science Inc.
Dec 21, 2020 SERF Novae Dual Mobility Cup Insert 49/28-ApeX-LNK Poly Liner. Intended for u... Acetabular Liners have a higher than acceptable oxidation limit, potential for patients to experi... Class II OMNIlife science Inc.
Sep 11, 2019 OMNI Hip System Model, Catalogue, or Order Number(s): HC-00070 Intended f... Stems missing porous coating on the device. Class II OMNIlife science Inc.
Jul 23, 2019 OMNIlife science, Inc. ApeX acetabular liner hip prosthesis component ... Acetabular liners failed the oxidation testing performed prior to release. They may experience a ... Class II OMNIlife science Inc.
Jul 23, 2019 OMNIlife science, Inc. ApeX acetabular liner hip prosthesis component ... Acetabular liners failed the oxidation testing performed prior to release. They may experience a ... Class II OMNIlife science Inc.
Jul 23, 2019 OMNIlife science, Inc. ApeX acetabular liner hip prosthesis component ... Acetabular liners failed the oxidation testing performed prior to release. They may experience a ... Class II OMNIlife science Inc.
Apr 12, 2019 OMNIBotics iBlock Cutting Guide, 4146-1000 - Product Usage: The OMNIBotics iB... The OMNIBotics iBlock Cutting Guide does not lock onto the iBlock Saw Guide as intended and may ... Class II OMNIlife science Inc.
Nov 29, 2018 OMNI K1 Broach Handle, Product Code HS-10054 There is a potential for the inner pin of the handle to become loose and fall out. Class II OMNIlife science Inc.
May 18, 2018 OMNI Hip System, ApeX-LNK Acetabular Inserts 0 degree, 4+mm offset, Product C... The Internal packaging, the pouch and patient labels are improperly labeled. Class II OMNIlife science Inc.
Nov 20, 2017 Apex Knee System, Tibial Baseplate Size 6 Left, non-porous - KC-2206L The ... The Apex Knee System Tibial Baseplate identified has an improper expiration date marked on the ex... Class II OMNIlife science Inc.
Jun 9, 2015 Offset Femoral Alignment Guide, 2mm x 6¿; Product Code: KS 67022 Product U... The markings on both versions of the OFFSET FEMORAL ALIGNMENT GUIDES are incorrect. Specifically,... Class II Omnilife Science Inc.
Jun 9, 2015 Offset Femoral Alignment Guide 4mm x 6¿; Product Code: KS 67024 Product Us... The markings on both versions of the OFFSET FEMORAL ALIGNMENT GUIDES are incorrect. Specifically,... Class II Omnilife Science Inc.
Jun 4, 2015 APEX INTERFACE Hemi 54X and Flared 56X, 3 Hole Acetabular Shells; Model: H5-1... The device may have improper screw hole placement due to inaccurate location of the index line. Class II Omnilife Science Inc.
Jun 3, 2015 Apex ARC Hip Stem, HA Coated, Size 5; Product Code: HC-21005-HA Product Us... Product may breach the inner and outer sterile pouches during shipping or handling. Class II Omnilife Science Inc.
May 9, 2014 Apex Arc Hip Stem, Size 2, HA Coated; Product Code: HC-21002-HA Staining on hip implant. Class II Omnilife Science 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.