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Browse Device Recalls

8 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 8 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 8 FDA device recalls.

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DateProductReasonClassFirm
Mar 5, 2015 Liquid Waste Bottle, Catalog#10291587. The Immulite 2000 systems are conti... The bottle assemblies were manufactured with a quality issue where in some cases the smaller diam... Class II Siemens Medical Solutions Diagnostics
Mar 5, 2015 Liquid Waste Bottle Kit, Catalog#10386287. The Immulite 2000 and 2000 XPi ... The bottle assemblies were manufactured with a quality issue where in some cases the smaller diam... Class II Siemens Medical Solutions Diagnostics
Mar 5, 2015 Water bottles, Catalog#10380062, #10291586. The Immulite 2000 and 2000 XPi... The bottle assemblies were manufactured with a quality issue where in some cases the smaller diam... Class II Siemens Medical Solutions Diagnostics
Mar 5, 2015 Direct Water feed Kit, Catalog#10373222 The bottle assemblies were manufactured with a quality issue where in some cases the smaller diam... Class II Siemens Medical Solutions Diagnostics
Mar 5, 2015 Water Feed Kit, Catalog#10288216,#10389714. The Immulite 2000 systems are ... The bottle assemblies were manufactured with a quality issue where in some cases the smaller diam... Class II Siemens Medical Solutions Diagnostics
Mar 5, 2015 Accessory Kit, Catalog#10282965, #10373217,#10286080. The Immulite 2000 sy... The bottle assemblies were manufactured with a quality issue where in some cases the smaller diam... Class II Siemens Medical Solutions Diagnostics
Apr 25, 2014 VersaCell X3 Solution and VersaCell X3 Expansion Pack, a robotic laboratory s... The keyboard and monitor may not be properly secured to the monitor arm. Class III Siemens Medical Solutions Diagnostics
Feb 3, 2014 IMMULITE 2000; IMMULITE 2000XPi; VersaCell The IMMULITE 2000 systems are c... There is a potential for incorrect results to be reported from processing of a sample tube. Class II Siemens Medical Solutions Diagnostics

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.