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Browse Device Recalls

14 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 14 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 14 FDA device recalls.

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DateProductReasonClassFirm
May 7, 2025 Brand Name: SmartRelease ESTR (Endoscopic soft tissue release system), Ony... Potential that the blade can unintentionally cut tissue prior to the user deploying the blade. Class II MicroAire Surgical Instruments, LLC
Jun 26, 2019 SmartRelease Endoscopic Carpal Tunnel Release Handpiece (ECTR handpiece), par... There was a higher than normal incidence rate of the blade not retracting when tightening. Class II MicroAire Surgical Instruments, LLC
Apr 19, 2018 MicroAire SmartRelease Endoscopic System, Endoscopic Carpal Tunnel Release, S... The Instructions for Use (IFU) is incorrect with regards to sterilization parameters and must be ... Class II MicroAire Surgical Instruments, LLC
May 22, 2017 SST TWIST DRILL, STANDARD, 1.6mm Dia. x 127mm, REF 8054-010, STERILE This ... One lot was found to contain both the correct twist drill (1.6mm) as well as an incorrect twist d... Class II MicroAire Surgical Instruments, LLC
Feb 21, 2017 MicroAire K-Wires Mislabeling on three lots of K-Wires. The incorrect product description " dual trocar" instead of... Class II MicroAire Surgical Instruments, LLC
May 6, 2016 Endotine Transbleph 3.5 (CFD-080-0167) MicroAire has initiated a limited recall (29 Units)on the Endotine Transbleph 3.5 (CFD-080-0167),... Class II MicroAire Surgical Instruments, LLC
Mar 11, 2016 Pneumatic Impactor, General Surgery, With Microaire Hose Connector Profes... MicroAire discovered that 20 suspect Impactor instruments ( MicroAire Pneumatic Impactor) were sh... Class II MicroAire Surgical Instruments, LLC
Feb 8, 2016 MicroAire PAL¿ Cannula Product Usage - Power Aspiration Device MicroAire has initiated a recall on product PAL-R4011XL (40cm x 4mm Del Vecchio French Rasp cann... Class II MicroAire Surgical Instruments, LLC
Feb 8, 2016 MicroAire PAL-R4011XL - 40cm x 4 mm Del Vecchio French Rasp aspiration cannula Complaints that the cannula bent/broke during surgery. Class II MicroAire Surgical Instruments, LLC
Jun 12, 2015 ASP-1020 LipoTower with Aspiration Pump. Medical use. There is potential risk of electrical shock if lead wires inside the device become detached and t... Class II MicroAire Surgical Instruments, LLC
Jun 12, 2015 ASP-1021 LipoTower with Aspiration Pump and Tumescent Pump. Medical use. There is potential risk of electrical shock if lead wires inside the device become detached and t... Class II MicroAire Surgical Instruments, LLC
Aug 12, 2013 Kirschner-Wire (K-Wire), packed in a clear tube with end caps, tubes packed i... A medical device used in surgical procedures was packaged in a pouch in which a defective seal ma... Class II MicroAire Surgical Instruments, LLC
Aug 12, 2013 Steinmann Pin, packed in a clear tube with end caps, tubes packed in a steril... A medical device used in surgical procedures was packaged in a pouch in which a defective seal ma... Class II MicroAire Surgical Instruments, LLC
Apr 26, 2012 Lipofilter 3000, model ASP-CAN-2, labeled in part ***MicroAire, 1641 Edlich D... Medical device was not manufactured under Good Manufacturing Procedures and a user may be unable ... Class II MicroAire Surgical Instruments, LLC

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.