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Browse Device Recalls

9 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 9 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 9 FDA device recalls.

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DateProductReasonClassFirm
May 23, 2019 E-Line Cutting Electrode 11.5Fr Mono 0 degrees, Sterile. One electrode is pl... E-Line Cutting Electrode package 8416.0305 contains E-Line Hook Electrode 8416.09 instead of E-Li... Class II Richard Wolf Medical Instruments Corp.
May 19, 2016 Conical portio adapter (acorn) small & large are used for examination and dia... The distal end of the Conical portio adapter (acorn) is composed of a small cap (head) that parti... Class II Richard Wolf Medical Instruments Corp.
Feb 29, 2016 The Vesa 75/100 adaptation with rotation is an accessory to a surgical camera... Supplier of the "VESA 75 / 100 adaptation with rotation", which is part of their monitor mounts a... Class II Richard Wolf Medical Instruments Corp.
Nov 25, 2015 Reuseable rotary blade/abrader, product number 899751514. The oval burr fron... Weak weld in the reusable rotary blade/abrader (burr) may result in inner part breaks at the dist... Class II Richard Wolf Medical Instruments Corp.
Nov 25, 2015 Reuseable rotary blade/abrader, product number 899751504. The oval burr late... Weak weld in the reusable rotary blade/abrader (burr) may result in inner part breaks at the dist... Class II Richard Wolf Medical Instruments Corp.
Nov 25, 2015 Reuseable rotary blade/abrader, product number 899751305. The round burr is... Weak weld in the reusable rotary blade/abrader (burr) may result in inner part breaks at the dist... Class II Richard Wolf Medical Instruments Corp.
Dec 10, 2014 The I-Cart is used to store, transport, and power video equipment used in med... The transformers installed on carts used for Richard Wolf medical video systems may overheat caus... Class II Richard Wolf Medical Instruments Corp.
Jul 9, 2014 The Hulka Clip is a sterile packaged medical device that carries a two year e... Richard Wolf Medical Instrument Corporation is recalling Hulka Clip Tubal Occluding Device lot 51... Class II Richard Wolf Medical Instruments Corp.
Sep 18, 2013 Individual units labeled in part: REF: 4630022; for S(a)line resectoscopes; V... Richard Wolf Medical Instrument Corporation recieved a complaint stating that a 4630024 vaporizat... Class II Richard Wolf Medical Instruments Corp.

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.