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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
Aug 29, 2023 Arjo medical beds, Models Enterprise 5000X, Enterprise 8000X, Enterprise 9000... Unintended movement of bed wheels Class II ARJOHUNTLEIGH POLSKA Sp. z.o.o.
Aug 29, 2023 Arjo medical beds, Models Enterprise 5000X, Enterprise 8000X, Enterprise 9000... Unintended movement of bed wheels Class II ARJOHUNTLEIGH POLSKA Sp. z.o.o.
Apr 5, 2022 Sara Plus Active Floor Lift The device may emit smoke or ignite. Class I ARJOHUNTLEIGH POLSKA Sp. z.o.o.
Jun 10, 2021 Arjo Citadel beds originally assembled with the IndiGo modules during manufct... The IndiGo power cord might wear during use which could lead to its damage, resulting in the cord... Class II ARJOHUNTLEIGH POLSKA Sp. z.o.o.
Jul 21, 2020 Bariatric Bed Frame System The Citadel Plus Bariatric Bed Frame System is ... Modular Junction Box (MJB) cables can melt and affect the bed functionality. Class II ARJOHUNTLEIGH POLSKA Sp. z.o.o.
Aug 22, 2019 Concerto & Basic Shower Trolly, Model Numbers BAB1000-01 (UDI: (01)050559827... The firm has become aware that any of the 4 safety catches may exhibit a mechanical failure (brea... Class II ARJOHUNTLEIGH POLSKA Sp. z.o.o.
Oct 22, 2018 ARJOHUNTLEIGH GETINGE GROUP Flites Passive Clip Sling - Product Usage: The ... Inspection process at the manufacturer found nonwoven material was used in specific lots of produ... Class II ARJOHUNTLEIGH POLSKA Sp. z.o.o.
Jun 29, 2016 ArjoHuntleigh Sara Combilizer; Intended to facilitate early immobilization, r... ArjoHuntleigh has concluded that a device tipping hazard may occur on the current Sara Combilizer... Class II ARJOHUNTLEIGH POLSKA Sp. z.o.o.
Jul 28, 2014 Minstrel (with scale) Product Usage: is a mobile passive hoist. It is inte... ArjoHuntleigh received three reports where the bolt under the scale unscrewed from the scale. The... Class II ARJOHUNTLEIGH POLSKA Sp. z.o.o.

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.