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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
Jun 14, 2017 ArjoHuntleigh Flowtron ACS900, medical pump, software V1.099 Device is used ... Reports of the device failure involving delivering continuous pressure to the calf garment and no... Class II Arjo, Inc. dba ArjoHuntleigh
Dec 21, 2015 The Concerto Basic Shower Trolley is intended for assisted hygiene care, espe... Reports of the bolts connecting the stretcher to the hydraulic piston and the stretcher tilting m... Class II Arjo, Inc. dba ArjoHuntleigh
Jan 21, 2013 Medium 2-Hooks Spreader Bar for use with Loop Slings, sizes small, medium and... The upper portion of the hooks on the spreader bar are too flexible for holding the loops of the ... Class II Arjo, Inc. dba ArjoHuntleigh
Dec 10, 2012 Flowtron Trio DVT Pump; an Rx intermittent pneumatic compression deep vein th... The Flowtron Trio DVT Pump has been marketed without proper FDA Approval. Class II Arjo, Inc. dba ArjoHuntleigh
Nov 16, 2012 Enterprise 9000 Bed; an AC-powered adjustable hospital bed with built-in elec... ArjoHuntleigh has received reports of unintended movement where the backrest and/or thigh section... Class II Arjo, Inc. dba ArjoHuntleigh
Nov 16, 2012 Enterprise 8000 Bed; an AC-powered adjustable hospital bed; ArjoHuntleigh AB,... ArjoHuntleigh has received reports of unintended movement where the backrest and/or thigh section... Class II Arjo, Inc. dba ArjoHuntleigh
Jun 29, 2012 Encore Mobile Patient Lifter; manufactured by Arjo Ltd., St. Catherine Street... ArjoHuntleigh has received a limited number of customer reports concerning injuries related to an... Class II Arjo, Inc. dba ArjoHuntleigh
Jun 29, 2012 Sara Plus Mobile Patient Lifter; manufactured for Arjo by Medibo Medical Prod... ArjoHuntleigh has received a limited number of customer reports concerning injuries related to an... Class II Arjo, Inc. dba ArjoHuntleigh
Jun 29, 2012 Chorus Mobile Patient Lifter; manufactured by Arjo Ltd., St. Catherine Street... ArjoHuntleigh has received a limited number of customer reports concerning injuries related to an... Class II Arjo, Inc. dba ArjoHuntleigh

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.