Browse Device Recalls

15 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 15 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 15 FDA device recalls.

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DateProductReasonClassFirm
Feb 10, 2022 Nextra Hammertoe Correction System 4.5 Middle and 3.2 Proximal Saw Cut SKU:... Proximal end of the driver is oversized in varying degrees, making it difficult to fully connect ... Class II Nextremity Solutions
Feb 10, 2022 Nextra Hammertoe Correction System 4.5 Middle 3.2 Proximal Kit SKU: NX-4532... Proximal end of the driver is oversized in varying degrees, making it difficult to fully connect ... Class II Nextremity Solutions
Feb 10, 2022 Nextra Hammertoe Correction System 3.5 Middle 3.2 Proximal Kit SKU: NX-3532... Proximal end of the driver is oversized in varying degrees, making it difficult to fully connect ... Class II Nextremity Solutions
Feb 10, 2022 Nextra Hammertoe Correction System Driver SKU: NX-DR Orthopedic surgical ... Proximal end of the driver is oversized in varying degrees, making it difficult to fully connect ... Class II Nextremity Solutions
Feb 10, 2022 Nextra Hammertoe Correction System 3.5 Middle and 3.2 Proximal Saw Cut SKU:... Proximal end of the driver is oversized in varying degrees, making it difficult to fully connect ... Class II Nextremity Solutions
Jan 13, 2022 Nextra Cannulated Hammertoe Standard Instrument Kit-indicated for small bone ... During insertion of the middle phalanx implant into bone, the driver may deform the implant locki... Class II Nextremity Solutions
Jan 13, 2022 Nextra CH Cannulated Hammertoe Mini Instrument Kit-indicated for small bone r... During insertion of the middle phalanx implant into bone, the driver may deform the implant locki... Class II Nextremity Solutions
Mar 26, 2021 InCore Lapidus Disposable Kit 28mm Right, Part Number: IC-LAP-28R - Product U... Product could potentially contain an undersized inner diameter of the 40mm drill bushing which re... Class II Nextremity Solutions
Mar 26, 2021 InCore Lapidus Disposable Kit 28mm Left, Part Number: IC-LAP-28L - Product Us... Product could potentially contain an undersized inner diameter of the 40mm drill bushing which re... Class II Nextremity Solutions
Feb 12, 2020 Nextra Hammertoe Correction System-4.5MM Middle, 3.2MM Proximal, SS, Sterile.... Proximal end of the driver in the affected product may be oversized in varying degrees, potentia... Class II Nextremity Solutions
Dec 16, 2019 Stratum Lapidus Plate - Small Rt, Part No. STRM-LAP-SMR, UDI 00817701025467. ... The product contains a different plate than indicated by the package labeling. The product is lab... Class II Nextremity Solutions
Nov 11, 2019 Stratum MDS Screw 3.5x48mm ST Part Number: STRM-MDS-3548ST Components 2mm shorter than indicated on the package label Class II Nextremity Solutions
Nov 11, 2019 Stratum MDS Screw 3.5x46mm ST Part Number: STRM-MDS-3546ST Components 2mm shorter than indicated on the package label Class II Nextremity Solutions
Nov 11, 2019 Stratum MDS Screw 3.5x50mm ST Part Number: STRM-MDS-3550ST Components 2mm shorter than indicated on the package label Class II Nextremity Solutions
Oct 9, 2019 Stratum Foot Plating System-NL LP Screw 3.5x50mm ST, sterile. Catalog Number... Product labeled as STRM-NL-3550ST, NL LP Screw 3.5x50mm ST, lot M1151 may contain the incorrect s... Class II Nextremity Solutions

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.