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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
Jan 30, 2017 A-series lift - A625 Manual w/Load Cell & Wi-Fi, Omni Part No. 324124. Prism... During internal cycle test at max load (625 lbs.) 2 units had straps break prematurely. Class II ErgoSafe Products, LLC (DBA) Prism Medical
Jan 30, 2017 A-series lift - A625 Manual Part No. 324117. Prism Medical. During internal cycle test at max load (625 lbs.) 2 units had straps break prematurely. Class II ErgoSafe Products, LLC (DBA) Prism Medical
Aug 30, 2016 Carry bar which is an accessory to a lift used for patients in hospitals and ... The black plastic puck on the carry bar is breaking resulting in potential for patient harm. Class II ErgoSafe Products, LLC (DBA) Prism Medical
Sep 8, 2015 Prism Medical C-300 Consumer Ceiling Lift; PN 330050, 330050R, 330053, 330053... Drive shaft and over speed arm may simultaneously fail potentially resulting in a patient falling... Class II ErgoSafe Products, LLC (DBA) Prism Medical
Sep 8, 2015 Prism Medical P-300 Portable Consumer Lift; PN 303050, 303050R, and 303051; w... Drive shaft and over speed arm may simultaneously fail potentially resulting in a patient falling... Class II ErgoSafe Products, LLC (DBA) Prism Medical
Jun 24, 2015 Prism Medical P-600 Portable Ceiling Lift; PN 303090. Patient lift with weigh... There is a potential the sling loops may not stay attached to the carry bar hooks. Class II ErgoSafe Products, LLC (DBA) Prism Medical
Jun 24, 2015 Prism Medical P-440 Portable Ceiling Lift; PN 303070 and 303070R (refurbished... There is a potential the sling loops may not stay attached to the carry bar hooks. Class II ErgoSafe Products, LLC (DBA) Prism Medical

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.