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Browse Device Recalls

4 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 4 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 4 FDA device recalls.

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DateProductReasonClassFirm
Jul 15, 2015 iChemVELOCITY Automated Urine Chemistry Catalog No. 800-3049, 800-3050, 800-3... Iris International is recalling the iChemVELOCITY systems because they do not maintain the on-boa... Class II Iris Diagnostics
Dec 3, 2014 RTH8 Rotor, P/N X01-005847-001. RTH8 used in the StatSpin Express 4 Horizont... Iris International is recalling the RTH8 Rotor used in the StatSpin Express 4 Horizontal Centrifu... Class II Iris Diagnostics
Sep 18, 2012 Iris Diagnostics Division iQ Control/Focus Set, Part Number 800-3104, Lot Num... The firm initiated this recall because complaints from customers reported that the recovery comp... Class II Iris Diagnostics
Jul 9, 2012 IRISpec" CA/CB two-part urine chemistry control twin set, Iris Diagnostics pa... The firm recalled after it received complaints of IRISpec CA/CB two part Urine Chemistry Control,... Class III Iris 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.