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Browse Device Recalls

9 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 9 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 9 FDA device recalls.

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DateProductReasonClassFirm
May 1, 2023 EliA GliadinDP IgG Well in the Phadia 2500EE instrument (Material Number 1241... Higher reported results when running EliA GliadinDP IgG Well on the instruments Phadia 2500EE com... Class II Phadia US Inc
May 1, 2023 Phadia 2500EE instrument -Intended for the in vitro semi-quantitative measure... Higher reported results when running EliA GliadinDP IgG Well on the instruments Phadia 2500EE com... Class II Phadia US Inc
Dec 14, 2020 EliA dsDNA Well - Product Usage: intended for the In-Vitro quantitative measu... Decreased values for EliA ANA Positive Control when using the EliA dsDNA Well lot BFA37/0142 may ... Class II Phadia US Inc
Dec 18, 2017 ImmunoCAP Allergen c6, Amoxicilloyl ( Article number 14-4451-016). ImmunoC... The stability specifications of ImmunoCAP Allergen c6, Amoxicilloyl were not met. Class II Phadia US Inc
Dec 18, 2017 ImmunoCAP Allergen c5, Ampicilloyl (article number 14-4450-01). ImmunoCAP ... The stability specifications of ImmunoCAP Allergen c5, Ampicilloyl were not met. Class II Phadia US Inc
Jul 5, 2017 Phadia 1000 Instrument, Article Number 12-3800-01. The "Retry" command does not function properly which could cause a shortage of Wash and Rinse sol... Class II Phadia US Inc
Jan 30, 2017 EliA Sample Diluent, Article number, 83-1023-01 Erroneous EliA test results related to problems with liquid level detection and diluent pipetting... Class II Phadia US Inc
Nov 20, 2014 Phadia 1000 Instrument (introduced as UniCAP 1000), Article number: 12-3800-0... During an investigation of instrument logs it was determined that In specific circumstances invol... Class II Phadia US Inc
Aug 2, 2012 PHADIA Varelisa Cardiolipin IgM Cardiolipin autoantibody immunological test ... Customers were not following the labeled assay procedure. This was due to a letter issued to them... Class III Phadia US 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.