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Browse Device Recalls

18 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 18 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 18 FDA device recalls.

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DateProductReasonClassFirm
Mar 19, 2024 TriMed, Threaded IM Nail 3.6mm, 60mm, TI, Ref: IMN3.6-60 T, Non Sterile, MD, ... Nail system contains an out of specification driver-socket which could result in inability to pi... Class II TriMed Inc.
Mar 19, 2024 TriMed, Threaded IM Nail 3.6mm, 60mm, TI, Ref: IMN3.6-60 T, Non Sterile, MD, ... Nail system contains an out of specification driver-socket which could result in inability to pi... Class II TriMed Inc.
Nov 28, 2023 Volar Bearing Plate. REF: VBEAL-3-7N, VBEAL-5-7N, VBEAL-3-7S, VBEAL-5-7S,... Plates, part of a wrist fixation system, are affixed during surgery with bearings that may pop ou... Class II TriMed Inc.
Dec 22, 2022 RipCord Syndesmosis Button, REF: STA001K Overly aggressive tension on the pull suture, while passing the medial button through a bone/soft... Class II TriMed Inc.
Sep 28, 2018 TriMed Wrist Hook Dorsal Impactor, REF IMPCT-WHD; and TriMed Wrist Hook Volar... The WHD/WHV impactors can rust over time due to an improper manufacturing process. Class II TriMed Inc.
Sep 28, 2018 TriMed Hex Driver 1.2, 55mm AO Cannulated, REF HXDRIVR-1.2C AO, nonsterile, R... The epoxy on Apex manufactured epoxy-coated instruments can pop off. Class II TriMed Inc.
Sep 28, 2018 TriMed Locking Drill Guide, 2.3mm, REF GUIDELCBS-2.3, nonsterile, Rx. The fi... The epoxy on Apex manufactured epoxy-coated instruments can pop off. Class II TriMed Inc.
Sep 28, 2018 TriMed Peg Guide Extender, REF PEG-XTNDR, nonsterile, Rx. The firm name on t... The spring on the PEG-Extender can rust due to the type of steel used to manufacture it. Class II TriMed Inc.
Sep 28, 2018 TriMed Countersink 1.7mm, HCS, REF HSINK-1.7, nonsterile, Rx. The firm name ... The epoxy on Apex manufactured epoxy-coated instruments can pop off. Class II TriMed Inc.
Aug 24, 2018 TriMed Hex Cortical Screw 4.0, 40 mm, REF HEX4.0-40, non-Sterile, RX, a compo... The bone screw is shorter than the intended design specification. Class II TriMed Inc.
Aug 24, 2018 TriMed Dorsal Wrist Hook Plate, Dorsal, 4-Hole, REF WHD-4, contained in a tra... Modifications to the specification were not appropriately qualified through the company's design ... Class II TriMed Inc.
Aug 15, 2018 TriMed Olecranon Hook Plate, Lt, 6-Holes, REF: OHOOKL-6, Non-Sterile, RX only... The firm has become aware that the angled-hole of certain semi-tubular design bone plates may hav... Class II TriMed Inc.
Apr 16, 2018 Ulnar Osteotomy Compression Plate, Short Model: UOCP-S Product Usage: Th... Two instrument holes located on the side of the plate, which act to align the saw guide are locat... Class II TriMed Inc.
Apr 13, 2018 Nitinol Staple, Elastic Staple Small-Symmetrical, Sterile R, Model #: a) ES-0... During a retrospective review of sterilization records, TriMed has determined that evidence of qu... Class II TriMed Inc.
Apr 13, 2018 Nitinol Staple, Elastic Staple Large-Asymmetrical, Sterile R, Model #: a) ES-... During a retrospective review of sterilization records, TriMed has determined that evidence of qu... Class II TriMed Inc.
Apr 13, 2018 Nitinol Staple, Elastic Staple Large-Symmetrical, Sterile R, Model #: a) ES-1... During a retrospective review of sterilization records, TriMed has determined that evidence of qu... Class II TriMed Inc.
Apr 13, 2018 Nitinol Staple, Elastic Staple Small-Asymmetrical, Sterile R, Model #: a) ES-... During a retrospective review of sterilization records, TriMed has determined that evidence of qu... Class II TriMed Inc.
Jan 11, 2018 Hex Driver Part Number HXDRIVER-2.0 AO; Hex Driver Part Number HXDRIVR-2.5 AO... Following the completion of sterilization cycle(s) of the impacted Hex Driver, the epoxy color ba... Class II TriMed Inc.

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.