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Browse Device Recalls

12 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 12 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 12 FDA device recalls.

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DateProductReasonClassFirm
Aug 30, 2024 Predict+ is a data-driven, clinical decision support tool that uses machine l... Predict+ is being recalled for lack of pre-market clearance/approval. Class II Blue Ortho
Sep 10, 2020 Instructions For Use document of the GPS Trackers. Appropriateness of the language used in the Tracker reprocessing instruction. Reason is that some... Class II Blue Ortho
Sep 22, 2019 Blue Ortho TKA Pro v2.1 software installed on the Exactech GPS system -indica... The navigated values displayed when using the LPI instrumentation are incorrect due to software i... Class II Blue Ortho
Mar 22, 2013 ORTHOCORD One Violet and One Blue Braided Composite Suture with MO-7 Taper Ne... The IFU provided with the free strand ORTHOCORD sutures currently indicates that approximately 10... Class II DePuy Mitek, Inc., a Johnson & Johnson Co.
Mar 22, 2013 ORTHOCORD ONE VIOLET AND ONE BLUE BRAIDED COMPOSITE SUTURE 2 (5 METRIC), Cata... The IFU provided with the free strand ORTHOCORD sutures currently indicates that approximately 10... Class II DePuy Mitek, Inc., a Johnson & Johnson Co.
Mar 22, 2013 ORTHOCORD One Violet and One Blue Braided Composite Suture with OS-6 Reverse ... The IFU provided with the free strand ORTHOCORD sutures currently indicates that approximately 10... Class II DePuy Mitek, Inc., a Johnson & Johnson Co.
Mar 22, 2013 ORTHOCORD BLUE BRAIDED COMPOSITE SUTURE 2 (5 METRIC), Catalog Number: 223111.... The IFU provided with the free strand ORTHOCORD sutures currently indicates that approximately 10... Class II DePuy Mitek, Inc., a Johnson & Johnson Co.
Mar 22, 2013 ORTHOCORD One Violet and One Blue Braided Composite Suture with MO-6 Taper Ne... The IFU provided with the free strand ORTHOCORD sutures currently indicates that approximately 10... Class II DePuy Mitek, Inc., a Johnson & Johnson Co.
Sep 6, 2012 SpiraLok 6.5 w/Needles with violet and blue Orthocord Product Number: 222987... Fracture of SPIRALOK Anchors post op, requiring patient revision Class II DePuy Mitek, Inc., a Johnson & Johnson Co.
Sep 6, 2012 SpiraLok 5.0 w/Needles with violet and blue Orthocord Product Number: 222985... Fracture of SPIRALOK Anchors post op, requiring patient revision Class II DePuy Mitek, Inc., a Johnson & Johnson Co.
Sep 6, 2012 SpiraLok 6.5 w/out Needles with violet and blue Orthocord Product Number: 22... Fracture of SPIRALOK Anchors post op, requiring patient revision Class II DePuy Mitek, Inc., a Johnson & Johnson Co.
Sep 6, 2012 SpiraLok 5.0 w/out Needles with violet and blue Orthocord Product Number: 22... Fracture of SPIRALOK Anchors post op, requiring patient revision Class II DePuy Mitek, Inc., a Johnson & Johnson Co.

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.