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Browse Device Recalls

10 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 10 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 10 FDA device recalls.

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DateProductReasonClassFirm
Aug 10, 2018 Pointe Scientific AutoHDL/LDL Cholesterol Calibrator, Catalog Number H7545-CA... Vials of the autoHDL/LDL Calibrator were shipped without a vial label. Class III Medtest Holdings, Inc.
Apr 3, 2015 Liquid stable 2 part Homocysteine Reagent, for in vitro quantitative determin... Deterioration in performance of the Liquid Stable (LS) 2-Part HOMOCYSTEINE REAGENT resulting in u... Class II Medtest Holdings, Inc.
Oct 23, 2014 MedTest DX Assayed Human Multi Sera Control Level 1 (HNC200) and Level 2 (HEC... MedTest DX Assayed Human Multi Sera Control Level 1 (HNC200) and Level 2 (HEC200) control values... Class III Medtest Holdings, Inc.
May 15, 2014 Pointe Scientific Chemistry Controls Level I and II LEVl: Amber glass vial... The original mean assigned to the control too high, upon reassignment with additional data the ne... Class III Medtest Holdings, Inc.
Mar 13, 2012 Pointe Scientific Hitachi Total Bilirubin Rl Reagent Product Usage: Two p... Decrease reactivity of R 1 component. Class II Medtest Holdings, Inc.
Feb 15, 2012 Pointe Scientific Hitachi AST Reagent R1 : PE plastic bottle w/PP plastic ... A Discrepancy was found on Hitachi AST (HA7 61) package insert. Limitations section indicates li... Class III Medtest Holdings, Inc.
Oct 19, 2011 Pointe Scientific Liquid Creatine Kinase Reagent Set Device is a kit compris... Linear performance information in product insert does not match that listed in the approved prema... Class III Medtest Holdings, Inc.
Jul 8, 2011 Pointe Scientific Lactate Dehydrogenase (Liquid) Reagent Set Model Number(s... Pointe Scientific Lactate Dehydrogenase (Liquid) Reagent Set stability claim is not being met. Class II Medtest Holdings, Inc.
Nov 22, 2010 The Pointe Scientific CK-MB Isoenzyme Control Pointe Scientific CK-MB Level ... Incorrect control range in product labeling Class III Medtest Holdings, Inc.
Jul 21, 2009 Pointe Scientific CRP(HS) Wide Range Control Set and Pointe Scientific CRP(H... Individual vials of calibrator and standard were mislabeled; specifically the units on the vial l... Class III Medtest Holdings, 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.