Browse Device Recalls

13 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 13 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 13 FDA device recalls.

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DateProductReasonClassFirm
Apr 10, 2025 Blueprint Software, BPUE001. Intended for use by surgeons as a pre surgical ... A software bug in Blueprint version 4.2.1 prevents users from accessing cases initiated in previo... Class II Tornier S.A.S.
Mar 5, 2025 stryker Blueprint Mixed Reality Glenoid Box Lid, Catalog Number MRUE205, pack... Stryker identified an elevated complaint rate related to difficulties using the Blueprint Mixed R... Class II Tornier S.A.S.
Mar 5, 2025 stryker HoloBlueprint Application, Catalog Number MRUE001; Total Shoulder Art... Stryker identified an elevated complaint rate related to difficulties using the Blueprint Mixed R... Class II Tornier S.A.S.
Mar 5, 2025 stryker Blueprint Mixed Reality Instrument Check Block, Catalog Number MRUE20... Stryker identified an elevated complaint rate related to difficulties using the Blueprint Mixed R... Class II Tornier S.A.S.
Mar 5, 2025 stryker Blueprint Mixed Reality BP MxR Glenoid Pin Guide PPSU + Stainless Ste... Stryker identified an elevated complaint rate related to difficulties using the Blueprint Mixed R... Class II Tornier S.A.S.
Mar 5, 2025 stryker Blueprint Mixed Reality Box Base, Catalog Number MRUE204, packaged in... Stryker identified an elevated complaint rate related to difficulties using the Blueprint Mixed R... Class II Tornier S.A.S.
Mar 5, 2025 stryker Blueprint Mixed Reality Instrument Kit, Catalog Number MRUEGLN; Total... Stryker identified an elevated complaint rate related to difficulties using the Blueprint Mixed R... Class II Tornier S.A.S.
Mar 5, 2025 stryker Blueprint Mixed Reality Depth Stop Pin, Catalog Number MRUE206; Total... Stryker identified an elevated complaint rate related to difficulties using the Blueprint Mixed R... Class II Tornier S.A.S.
Mar 5, 2025 stryker Blueprint Mixed Reality Glenoid Digitizer, Catalog Number MRUE201, pa... Stryker identified an elevated complaint rate related to difficulties using the Blueprint Mixed R... Class II Tornier S.A.S.
Mar 5, 2025 stryker Blueprint Mixed Reality Coracoid Clamp, Catalog Number MRUE202, packa... Stryker identified an elevated complaint rate related to difficulties using the Blueprint Mixed R... Class II Tornier S.A.S.
Dec 18, 2024 Stryker Blueprint Mixed Reality BP MxR Glenoid Pin Guide, REF MRUE200. Ind... The Pin Guide is being recalled because the metal tube may disassemble from the plastic handle. T... Class II Tornier S.A.S.
Apr 16, 2024 Stryker Blueprint Software, Catalog #BPUE001. The software bug allows for case planning with anatomic glenoid Perform / Perform Augmented impla... Class II Tornier S.A.S.
Jun 25, 2021 The Aequalis Pyrocarbon Humeral Heads. Shoulder implant component. Sold OUS... Potential patient exposure to the graphite substrate. Class II Tornier S.A.S.

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.