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Browse Device Recalls

64 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 64 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 64 FDA device recalls.

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DateProductReasonClassFirm
Jul 3, 2023 LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 17 - indicated for p... Increased force may be required to remove the LINK MP Monoblock trial hip stem (Sizes 14mm - 25mm... Class II Waldemar Link GmbH & Co. KG (Mfg Site)
Dec 23, 2022 LinkSymphoKnee Distal Femoral Augment - Tilastan - Size 7-8, Medial-Right/Lat... Fixation screw was inserted through the wrong side of the augment (distal to proximal, as opposed... Class II Waldemar Link GmbH & Co. KG (Mfg Site)
Dec 23, 2022 LinkSymphoKnee Distal Femoral Augment - Tilastan - Size. 7-8, Lateral-Right/M... Fixation screw was inserted through the wrong side of the augment (distal to proximal, as opposed... Class II Waldemar Link GmbH & Co. KG (Mfg Site)
May 24, 2022 Tibial Component. orthopedic prosthesis. Model Nos: Small, W 16-2817/02 ... There is a risk that blind screws of the modular tibial component cannot be loosened intraoperati... Class II Waldemar Link GmbH & Co. KG (Mfg Site)
May 24, 2022 Endo Model Modular Femur and Tibia, PorEx. orthopedic prosthesis. Model Nos... There is a risk that blind screws of the modular tibial component cannot be loosened intraoperati... Class II Waldemar Link GmbH & Co. KG (Mfg Site)
May 24, 2022 Endo Model Modular Rotational Tibia - Small (Model No #15-2814/02), Medium (M... There is a risk that blind screws of the modular tibial component cannot be loosened intraoperati... Class II Waldemar Link GmbH & Co. KG (Mfg Site)
May 24, 2022 Tibial Component Modular. orthopedic prosthesis. Model Nos: Small, W 16-2... There is a risk that blind screws of the modular tibial component cannot be loosened intraoperati... Class II Waldemar Link GmbH & Co. KG (Mfg Site)
Mar 18, 2021 LINK Endo-Model Modular Knee Prosthesis System Femoral Segment, Size 4, Right The firm discovered through customer complaints that device segments may not meet specifications. Class II Waldemar Link GmbH & Co. KG (Mfg Site)
Mar 18, 2021 LINK Endo-Model Modular Knee Prosthesis System Femoral Segment, Size 3, Right The firm discovered through customer complaints that device segments may not meet specifications. Class II Waldemar Link GmbH & Co. KG (Mfg Site)
Mar 18, 2021 LINK Endo-Model Modular Knee Prosthesis System Femoral Segment, Size 4, Left The firm discovered through customer complaints that device segments may not meet specifications. Class II Waldemar Link GmbH & Co. KG (Mfg Site)
Mar 18, 2021 LINK Endo-Model Modular Knee Prosthesis System Femoral Segment, Size 3, Left The firm discovered through customer complaints that device segments may not meet specifications. Class II Waldemar Link GmbH & Co. KG (Mfg Site)
Dec 7, 2018 LINK STEM with Microporous Surface MP Reconstruction Prosthesis, CEMENTLESS (... The reaming guide and the guide rod can't be screwed into the intended depth. The reason for this... Class II Waldemar Link GmbH & Co. KG (Mfg Site)
Dec 4, 2018 BiMobile UHMWPE Liner: ID-28mm/OD-50mm, Reference Number 184-260/02 The LI... The internal labeling included with these implants may include incorrect part numbers and could r... Class II Waldemar Link GmbH & Co. KG (Mfg Site)
Dec 4, 2018 BiMobile UHMWPE Liner: ID-28mm/OD-54mm, Reference Number 184-260/04 The LI... The internal labeling included with these implants may include incorrect part numbers and could r... Class II Waldemar Link GmbH & Co. KG (Mfg Site)

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.