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Browse Device Recalls

5 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 5 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 5 FDA device recalls.

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DateProductReasonClassFirm
Oct 6, 2016 SCC Soft Computer Softbank II software Product Usage: Supports single and... Software error. Potential for incorrect results Class II Soft Computer Consultants, Inc.
Nov 26, 2014 SoftPath Laboratory Information System. Versions 4.3.0.8, 4.3.0.9, 4.3.0.10,... Modifications to diagnostic text may be: 1) Saved to the database but not appear on the report se... Class II SCC Soft Computer
May 20, 2014 SoftLab with SA HIS versions 4.0.7.0-4.0.7.1 SoftLab is a laboratory infor... The interface fails to send abnormal flags for Reference Lab test results. Class II SCC Soft Computer
Jan 29, 2014 SCC SA HIS version 4.0.7.0 when used with SoftMic version 4.0.7.0. SoftMi... When an isolate is resulted without a SNOMED code, isolate information in the downstream system m... Class II SCC Soft Computer
Oct 17, 2011 SoftLab with SA INST versions: 3.1.6.12, 4.0.1.26-4.0.1.32, 4.0.2.21-4.0.2.51... On 10/17/2011 SCC Soft Computer, Clearwater, FL initiated a correction on SoftLab with SA INST ve... Class II SCC Soft Computer

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.