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Browse Device Recalls

3 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3 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 3 FDA device recalls.

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DateProductReasonClassFirm
Nov 13, 2014 Illumina MiSeqDx Universal Kit 1.0, PN 15039608 The Illumina MiSeqDx Unive... It was discovered a software limitation with MiSeq Reporter software (version 2.2.31) when using ... Class II Illumina Inc
Nov 6, 2014 Illumina MiSeqDx Cystic Fibrosis Clinical Sequencing Assay in vitro diagnost... Illumina has confirmed a software limitation with MiSeq Reporter software (version 2.2.31) when u... Class III Illumina Inc
Jul 28, 2014 Illumina Worklist Manager (IWM) (software v1.0.15), a component of Illumina M... A software component of the MiSeqDx instrument, called the Illumina Worklist Manager (IWM) v1.0.... Class II Illumina Inc

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.