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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.

Clear
DateProductReasonClassFirm
Jun 2, 2022 Product Name: GCX Channel Mounting Accessory Model/Catalog Number: H8-300-40-A Under certain circumstances, the mounting screws may loosen or pull out from the attachment point... Class II Skytron, Div. The KMW Group, Inc
May 11, 2021 Skyton Bracket Flatscreen, Revision 2 & 3-The FS32 is a single monitor mounti... Failure of the FS32 Monitor Brackets from the mounting block could potentially loosen over time a... Class II Skytron, Div. The KMW Group, Inc
Sep 11, 2020 VGDF-SKY (R4-010-06) VGA TO FIBER CONVERTER-Single Format Faceplate, a compon... VGDF (VGA) Faceplate failure results in failure of video signal for SkyVision Linx 300, a seconda... Class II Skytron, Div. The KMW Group, Inc
Mar 10, 2020 SkyVision SDS System - Video Integration Model: GC-SDS-BSCB-200 - Product Us... Intermittent failure of a signal being sent to a monitor from the touch panel display causing the... Class II Skytron, Div. The KMW Group, Inc
Mar 5, 2020 Skytron Ergon 3 Series Skyboom Monitor Bracket-Flatscreen Bracket, single mon... Potential for the weld to fail at the pivot point of the monitor bracket. This weld failure could... Class II Skytron, Div. The KMW Group, Inc
Apr 18, 2019 Skytron Integrity 270 Steam Sterilizer and Skytron Integrity 270VP Steam P... Weld attaching the air heater assembly to the main sterilizer unit has shown signs of fatigue/fai... Class II Skytron, Div. The KMW Group, Inc
Apr 6, 2016 EZ Slide Battery/line powered hydraulic table with removable leg section and ... The potential exists within the identified tables that incorrectly manufactured parts have been u... Class II Skytron, Div. The KMW Group, Inc
Mar 28, 2016 Ergon III Series Skyboom Monitor Bracket. Part # 3FCM1 Flatscreen Bracket, s... Potential for the weld to fail at the pivot point of the monitor bracket. This weld failure coul... Class II Skytron, Div. The KMW Group, Inc
Dec 2, 2015 Ergon 2 Articulating Equipment Boom Monitor Brackets mounting point for di... The hardware that holds the VESA plate and the display interface / monitor to the bracket may fai... Class II Skytron, Div. The KMW Group, 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.