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Browse Device Recalls

12 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 12 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 12 FDA device recalls.

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DateProductReasonClassFirm
Aug 30, 2023 Citrine QTRAP Mass Spectrometer, Part Number 5063685 In rare occasions, the combination of a leak of a highly flammable solvent at the ion source prob... Class II AB Sciex, LLC
Aug 30, 2023 API3200MD Mass Spectrometer, Part Number 4466230 In rare occasions, the combination of a leak of a highly flammable solvent at the ion source prob... Class II AB Sciex, LLC
Aug 30, 2023 4500MD Triple Quad Mass Spectrometer, Part Number 5032522 In rare occasions, the combination of a leak of a highly flammable solvent at the ion source prob... Class II AB Sciex, LLC
Aug 30, 2023 Citrine Triple Quad Mass Spectrometer, Part Number 5063684 In rare occasions, the combination of a leak of a highly flammable solvent at the ion source prob... Class II AB Sciex, LLC
Oct 4, 2021 Cliquid MD version 3.4 software used in conjunction with Analyst MD software ... The values of the Internal Standard (IS) concentrations are incorrectly derived when the user bui... Class II AB SCIEX
Jun 16, 2016 AB SCIEX Triple Quad 4500MD LC/MS/MS System. Mass Spectrometer for In-Vitro... MultiQuant MD software where under certain conditions a user can be presented with incorrect qua... Class II Ab Sciex
Jun 16, 2016 AB SCIEX 3200MD QTRAP¿ LC/MS/MS System Mass Spectrometer for In-Vitro Diagn... MultiQuant MD software where under certain conditions a user can be presented with incorrect qua... Class II Ab Sciex
Jun 16, 2016 AB SCIEX QTRAP¿ 4500MD LC/MS/MS System Mass Spectrometer for In-Vitro Diagn... MultiQuant MD software where under certain conditions a user can be presented with incorrect qua... Class II Ab Sciex
Jun 16, 2016 AB Sciex API 3200MD" LC/MS/MS System. In-Vitro Diagnostic Instrument Part Nu... MultiQuant MD software where under certain conditions a user can be presented with incorrect qua... Class II Ab Sciex
Mar 25, 2016 AB Sciex Triple Quad 4500MD LC/MS/MS System, Part No. 5031257; and QTRAP 4500... Under certain conditions, mass spectrometers may report incorrect quantitative results. Class II Ab Sciex
Feb 24, 2016 Analyst¿ MD Version 1.6.1 and 1.6.2 Software used with the following instrume... Wrong quantitative results may be displayed in a report from the device, which may potentially le... Class II Ab Sciex
Jul 15, 2014 AB SCIEX API 3200MD" LC/MS/MS System with software: MultiQuantMD 3.0In vit... Software- AB SCIEX API 3200MD LC/MS/MS SYSTEM with MultiQuantMD 3.0 software may provide incorrec... Class II Ab Sciex

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.