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Browse Device Recalls

7 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 7 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 7 FDA device recalls.

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DateProductReasonClassFirm
Nov 5, 2024 Microscissor Tip (Disposable); Microline Catalog #: 3122. A lot of ReNew Microscissor Tips exhibited a 2% rate of failure in terms of the heat shrink break... Class II Microline Surgical, Inc.
Mar 22, 2019 TLS2 Thermal Ligating Shears, Catalog Number 132-131D The shears exhibited a high rate of complete or intermittent failure to actuate. As a result, th... Class II Microline Surgical, Inc.
Nov 1, 2017 ReNew Dolphin Nose Disposable Dissector Tip, Catalog Number: 3312, UDI: 00811... Certain lots of disposable laparoscopic instrument tips may potentially have a compromised steril... Class II Microline Surgical, Inc.
Nov 1, 2017 ReNew Endocut Scissor Disposable Tip, Catalog Number: 3142, UDI: 008110990121... Certain lots of disposable laparoscopic instrument tips may potentially have a compromised steril... Class II Microline Surgical, Inc.
Jul 13, 2017 The ReNew Reusable Grasper and Dissector Tips are to be used with the ReNew L... The heat-shrink insulation tube may split during autoclave sterilization/re-sterilization. If a s... Class II Microline Surgical, Inc.
May 12, 2014 Microline Surgical ReNew Laproscopic Fenestrated Grasper Forceps Tips Ref 3221 Potential for the Fenestrated Grasper Tip jaw to break when force is applied to the jaw Class II Microline Surgical, Inc.
May 12, 2014 Microline Surgical ReNew Laproscopic Fenestrated Grasper Forceps Tips (Reusab... Potential for the Fenestrated Grasper Tip jaw to break when force is applied to the jaw Class II Microline Surgical, 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.