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Browse Device Recalls

5 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 5 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 5 FDA device recalls.

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DateProductReasonClassFirm
Apr 19, 2016 Surgical Table Cushion (HybriGel Pads) HybrGel Pads are an optional accessor... The Surgical Table Cushion (HybriGel Pads) could potentially contain staples that's secure two un... Class II Berchtold Corp.
Sep 23, 2015 TELETOM EQUIPMENT MANAGEMENT SYSTEM 4 and 6 series TELETOM is designed for u... During the use of the TELETOM Series 4 & 6 there is potential for the controls and brakes not to ... Class II Berchtold Corp.
Mar 12, 2013 Hand Controls for Operon D750, D752, D760, D820 and D850 The hand controls... The firm received complaints for unintended movements. Class II Berchtold Corp.
Jul 10, 2012 Chromovision High Definition (HD) Wireless Camera, Pt # CC-9715900. Visual... Defective camera: There is a possibility that the connection of the wires to the connector may be... Class III Berchtold Corp.
Apr 16, 2012 OPERON D850 Surgical Table Product Usage: Surgical Table Table was not lowering. Class II Berchtold 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.