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Browse Device Recalls

10 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 10 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 10 FDA device recalls.

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DateProductReasonClassFirm
Jan 26, 2024 I.B.S¿ 6.5-C Compression screw - diam 6.5mm lg 75mm,Part Number S65 ST175 This Field Action is being conducted following the identification of a batch mix-up between I.B.S... Class II In2Bones, SAS
Jan 26, 2024 I.B.S¿ 6.5-C Compression screw - diam 6.5mm lg 80mm,Part Number S65 ST180 This Field Action is being conducted following the identification of a batch mix-up between I.B.S... Class II In2Bones, SAS
Feb 9, 2021 In2Bones Shannon Percutaneous Burr - Product Usage: indicated for forefoot m... This Field Action is being conducted following identification of manufacturing non-conformity of ... Class II In2Bones, SAS
Jul 13, 2017 Non-Locking screws in the following lengths: (a) NEO(R) 0.27 - 10 mm, REF W2... The firm received several customer complaints reporting some perioperative breakages of NE0411 No... Class II In2Bones, SAS
Dec 19, 2016 NEOVIEW(R) SCREWS SET, REF W27 ST900, STERILE R The NEOVIEW¿ Plating System... Dimensional non-conformity of the thread on the screw head. Class II In2Bones, SAS
Dec 19, 2016 NEO SCREW 02.7-14MM LOCKING, REF W27 ST114, In2Bones, 28 chemin du petit bois... Dimensional non-conformity of the thread on the screw head. Class II In2Bones, SAS
Dec 19, 2016 SCREW 02.7-12MM LOCKING, REF W27 ST112: a) DRP, b) NEO, In2Bones, 28 chemin ... Dimensional non-conformity of the thread on the screw head. Class II In2Bones, SAS
Nov 18, 2015 IBS - Osteosynthesis screws for bone fixation Model S25 ST014. One batch of osteosynthesis screws were manufactured with the incorrect Torx imprint on the screw... Class II In2Bones, SAS
Mar 9, 2015 DUAFIT(R) PIP 0o CA SIZE 2, REF A60 SP002, STERILE R, Rx only. Interphalan... Dimensional non-conformity leading to the impossibility to introduce the implant in the dedicated... Class II In2Bones, SAS
Mar 9, 2015 DUAFIT(R) PIP 0o CA SIZE 3, REF A60 SP003, STERILE R, Rx only. Interphalan... Dimensional non-conformity leading to the impossibility to introduce the implant in the dedicated... Class II In2Bones, SAS

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.