Browse Device Recalls

49 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 49 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 49 FDA device recalls.

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DateProductReasonClassFirm
Apr 25, 2023 LINK SymphoKnee System L-Shaped Femoral Augment, Medial-Right/Lateral-Left, S... Contains the incorrect implant in the packaging. The packaging incorrectly contains the opposite ... Class II Linkbio Corp.
Mar 21, 2023 LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 13MM X 50MM Item Numbe... Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product... Class II Linkbio Corp.
Mar 21, 2023 LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 13MM X 45MM Item Number:... Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product... Class II Linkbio Corp.
Mar 21, 2023 LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 7MM X 55MM Item Number:... Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product... Class II Linkbio Corp.
Mar 21, 2023 LINK SLED Knee System: ENDO SLED KNEE FEM COMP, MEDIUM Item Number: 15-2... Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product... Class II Linkbio Corp.
Mar 21, 2023 LINK SLED Knee System POREX ENDO SLED KNEE FEM COMP, LARGE Item Number: ... Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product... Class II Linkbio Corp.
Mar 21, 2023 LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 9X58MM Item Number: 15-20... Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product... Class II Linkbio Corp.
Mar 21, 2023 LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 13 MM X 45 MM It... Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product... Class II Linkbio Corp.
Mar 21, 2023 LINK SLED Knee System: ENDO MODEL SLED TIBIAL COMP 9 MM X 45 MM Item Nu... Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product... Class II Linkbio Corp.
Mar 21, 2023 LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 13MM X 55MM Item Number:... Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product... Class II Linkbio Corp.
Mar 21, 2023 LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 11 MM X 50 MM I... Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product... Class II Linkbio Corp.
Mar 21, 2023 LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 9MM X 45MM Item Number:... Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product... Class II Linkbio Corp.
Mar 21, 2023 LINK SLED Knee System: ENDO MODEL SLED TIBIAL COMP 11 MM X 45 MM Item Numb... Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product... Class II Linkbio Corp.
Mar 21, 2023 LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 11 MM X 45 MM It... Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product... Class II Linkbio Corp.
Mar 21, 2023 LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 13 MM X 55 MM I... Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product... Class II Linkbio Corp.
Mar 21, 2023 LINK SLED Knee System ENDO MODEL SLED TIBIAL COMP 8 MM X 55 MM Item Numb... Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product... Class II Linkbio Corp.
Mar 21, 2023 LINK SLED Knee System ENDO MODEL SLED TIBIAL COMP 8 MM X 45 MM Item Number... Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product... Class II Linkbio Corp.
Mar 21, 2023 LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 9 MM X 55 MM Ite... Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product... Class II Linkbio Corp.
Mar 21, 2023 LINK SLED Knee System ENDO MODEL SLED TIBIAL COMP 13 MM X 50 MM Item Num... Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product... Class II Linkbio Corp.
Mar 21, 2023 LINK SLED Knee System ENDO MODEL SLED TIBIAL COMP 9 MM X 55 MM Item Numbe... Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product... Class II Linkbio Corp.
Mar 21, 2023 LINK SLED Knee System ENDO MODEL SLED TIBIAL COMP 8 MM X 50 MM Item Num... Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product... Class II Linkbio Corp.
Mar 21, 2023 LINK SLED Knee System ENDO MODEL SLED TIBIAL COMP 13 MM X 55 MM Item Num... Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product... Class II Linkbio Corp.
Mar 21, 2023 LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 7MM X 45MM Item Number: 1... Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product... Class II Linkbio Corp.
Mar 21, 2023 LINK SLED Knee System: ENDO SLED KNEE FEM COMP, SMALL Item Number: 15-2020/40 Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product... Class II Linkbio Corp.
Mar 21, 2023 LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 11X58MM Item Number: 1... Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product... Class II Linkbio Corp.
Mar 21, 2023 LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 8 MM X 50 MM It... Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product... Class II Linkbio Corp.
Mar 21, 2023 LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 9MM X 55MM Item Number: 1... Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product... Class II Linkbio Corp.
Mar 21, 2023 LINK SLED Knee System ENDO MODEL SLED TIBIAL COMP 11 MM X 50 MM Item Nu... Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product... Class II Linkbio Corp.
Mar 21, 2023 LINK SLED Knee System ENDO MODEL SLED TIBIAL COMP 9 MM X 50 MM Item Number... Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product... Class II Linkbio Corp.
Mar 21, 2023 LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 8 MM X 45 MM Item ... Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product... Class II Linkbio Corp.
Mar 21, 2023 LINK SLED Knee System ENDO MODEL SLED TIBIAL COMP 11 MM X 55 MM Item Numb... Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product... Class II Linkbio Corp.
Mar 21, 2023 LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 9MM X 50MM Item Number: 1... Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product... Class II Linkbio Corp.
Mar 21, 2023 LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 7MM X 50MM Item Number:... Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product... Class II Linkbio Corp.
Mar 21, 2023 LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 13 MM X 50 MM I... Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product... Class II Linkbio Corp.
Mar 21, 2023 LINK SLED Knee System: ENDO SLED KNEE FEM COMP, Large Item Number: 15-202... Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product... Class II Linkbio Corp.
Mar 21, 2023 LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 11MM X 45MM Item Numbe... Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product... Class II Linkbio Corp.
Mar 21, 2023 LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 9 MM X 45 MM Item... Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product... Class II Linkbio Corp.
Mar 21, 2023 LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 9 MM X 50 MM It... Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product... Class II Linkbio Corp.
Mar 21, 2023 LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 13X58MM Item Number: 1... Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product... Class II Linkbio Corp.
Mar 21, 2023 LINK SLED Knee System ENDO MODEL SLED TIBIAL COMP 13 MM X 45 MM Item Number... Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product... Class II Linkbio Corp.
Mar 21, 2023 LINK SLED Knee System: ENDO SLED KNEE FEM COMP, MEDIUM SMALL Item Number:... Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product... Class II Linkbio Corp.
Mar 21, 2023 LINK SLED Knee System POREX ENDO SLED KNEE FEM COMP, SMALL Item Number: ... Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product... Class II Linkbio Corp.
Mar 21, 2023 LINK SLED Knee System POREX ENDO SLED KNEE FEM COMP, MEDIUM Item Number... Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product... Class II Linkbio Corp.
Mar 21, 2023 LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 11MM X 55MM Item Number... Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product... Class II Linkbio Corp.
Mar 21, 2023 LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 8 MM X 55 MM It... Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product... Class II Linkbio Corp.
Mar 21, 2023 LINK SLED Knee System POREX ENDO SLED KNEE FEM COMP, MEDIUM SMALL Item N... Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product... Class II Linkbio Corp.
Mar 21, 2023 LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 11MM X 50MM Item Numbe... Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product... Class II Linkbio Corp.
Mar 21, 2023 LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 11 MM X 55 MM Item... Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product... Class II Linkbio Corp.
Mar 21, 2023 LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 7MM X 58MM Item Number: 1... Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product... Class II Linkbio Corp.

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.