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Browse Device Recalls

22 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 22 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 22 FDA device recalls.

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DateProductReasonClassFirm
Oct 29, 2025 Medicrea, IB3D Universal Implant Inserter, Rx Only REF: A24000000 Due to complaints, orthopedic rotation tool handle may untread from the shaft resulting in the i... Class II Medicrea International
Oct 29, 2025 Medicrea, IB3D PL Instruments Set, Rx Only REF: SPS03174 Due to complaints, orthopedic rotation tool handle may untread from the shaft resulting in the i... Class II Medicrea International
Dec 3, 2024 UNiD" Adaptive Spine Intelligence UNiD Spine Analyzer Product Number SW300... Due to software anomalies that may impact on rod planning specifically, certain optional surgical... Class II Medicrea International
Jul 12, 2023 IMPIX ALIF S/A, REF number B15241415; intervertebral fusion device - lumbar There is a potential for a product packaging non-conformity issue which presents as a pinhole in ... Class II Medicrea International
Jul 12, 2023 PASS LP, REF numbers: a) B02315535Z, b) B02315540Z, c) B02315545Z, d... There is a potential for a product packaging non-conformity issue which presents as a pinhole in ... Class II Medicrea International
Jul 12, 2023 IMPIX TLIF, REF numbers: a) B15130607S, b) B15130609S, c) B15130611S, ... There is a potential for a product packaging non-conformity issue which presents as a pinhole in ... Class II Medicrea International
Jul 12, 2023 IMPIX 3D, REF numbers: a) B242C09122810, b) B242C10062810, c) B242C10... There is a potential for a product packaging non-conformity issue which presents as a pinhole in ... Class II Medicrea International
Jul 12, 2023 IMPIX DLIF, REF numbers: a) B16123509, b) B16123511, c) B16124009, ... There is a potential for a product packaging non-conformity issue which presents as a pinhole in ... Class II Medicrea International
Jul 12, 2023 IMPIX MANTA+, REF numbers: a) B20171743, b) B20171753, c) B20171763, ... There is a potential for a product packaging non-conformity issue which presents as a pinhole in ... Class II Medicrea International
Jul 12, 2023 GRANVIA-C, REF numbers: a)¿¿¿¿¿ A13111427, b)¿¿¿¿ A13112567, c)¿¿¿¿¿ A... There is a potential for a product packaging non-conformity issue which presents as a pinhole in ... Class II Medicrea International
Jul 12, 2023 IMPIX ALIF, REF numbers: a) B15111209, b) B15111212, c) B15111409, ... There is a potential for a product packaging non-conformity issue which presents as a pinhole in ... Class II Medicrea International
Jul 12, 2023 IMPIX MANTA, REF numbers: a) A20150407, b) A20250407, c) A20350567, ... There is a potential for a product packaging non-conformity issue which presents as a pinhole in ... Class II Medicrea International
Jul 12, 2023 IMPIX C+, REF numbers: a) B20240104, b) B20240105, c) B20240106, d)... There is a potential for a product packaging non-conformity issue which presents as a pinhole in ... Class II Medicrea International
Jul 12, 2023 IMPIX S, REF numbers: a) B15328071S, b) B15328073S, c) B15328074S, d... There is a potential for a product packaging non-conformity issue which presents as a pinhole in ... Class II Medicrea International
Oct 8, 2020 MEDICREA LIGAPASS TENSION PULLEY HANDLE XS- intended to provide thoracic and... Tightening the LIGAPASS Band with this instrument, the tensioner's pliers can crush the band caus... Class II Medicrea International
Jan 28, 2020 Iliac Screws, multiple sizes, Article Nos. B36020500 B36020570 B36020580 ... An internal component was assembled in the incorrect orientation, which may lead to the tulip hea... Class II Medicrea International
Jan 28, 2020 Pedicle Screws, multiple sizes, Article Nos. B36004525 B36004530 B360045... An internal component was assembled in the incorrect orientation, which may lead to the tulip hea... Class II Medicrea International
Nov 11, 2019 Medicrea International Universal Counter Torque for use with the Pass TULIP [... Incompatible universal counter torque (A22020500) with the nut driver T30 (A22020220) Class II Medicrea International
Oct 2, 2019 Medicrea TLIF-B Holder, short intended for Intervertebral body fusion device ... Inner draw rod, which threads into the cage may potentially be separated from the proximal knob o... Class II Medicrea International
Sep 16, 2019 Medicrea Pass LP Blunt K-wire 01.6mm x 500mm-Nitinol Product reference: A060... Conical Cannulated Screws may not accept 1.6mm K-Wire, it cannot enter the minimum tolerance axis... Class II Medicrea International
Sep 16, 2019 Medicrea Pass LP Trocar K-wire 01.6mm x 500mm-Nitinol Product reference : A0... Conical Cannulated Screws may not accept 1.6mm K-Wire, it cannot enter the minimum tolerance axis... Class II Medicrea International
Jun 27, 2019 Medicrea Pass LP, REF B02217545, Non Sterile, Material: Ti-6Al-4V ELI, VIS PE... It has been determined that some Pedicle system screw identified as 45mm long have an actual len... Class II Medicrea International

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.