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Browse Device Recalls

6 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 6 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 6 FDA device recalls.

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DateProductReasonClassFirm
Oct 28, 2025 Reagent Kits/ containing flow cells, components of NextSeq 550Dx Instrument: ... An instrument intended for sequencing DNA libraries with in vitro diagnostic assays is used with ... Class II Illumina, Inc.
Apr 5, 2023 NextSeq 550Dx Instrument, Catalog # 20005715, contaning Universal Copy Servic... Cybersecurity vulnerability concerning the software used for sequencing instruments. Class II Illumina, Inc.
Apr 5, 2023 MiSeq Dx Instrument, Catalog # M70101, containing Universal Copy Service (UCS... Cybersecurity vulnerability concerning the software used for sequencing instruments. Class II Illumina, Inc.
May 3, 2022 illumina REF DX-410-1001 Model: MiSeq Dx illumina REF 15036706 Model: MiSe... cybersecurity vulnerability Class II Illumina, Inc.
May 3, 2022 illumina Model NextSeq 550 Dx REF 20005715 cybersecurity vulnerability Class II Illumina, Inc.
Feb 22, 2022 Illumina NextSeq 550Dx, REF: 20005715, CE, IVD There is a potential that the DNA sequence analyzer may short circuit shortly after disconnection... 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.