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Browse Device Recalls

21 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 21 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 21 FDA device recalls.

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DateProductReasonClassFirm
Sep 18, 2024 A1CNow+ Multi-Test HbA1c System consists of (1) a semi-disposable plastic-enc... The reason for this recall is PTS Diagnostics, Inc. received complaints of non-matching cartridge... Class II Polymer Technology Systems, Inc. dba PTS Diagno...
Aug 16, 2022 PTS Panels CHOL+GLU Test Strips (REF 1765) Incorrect instructions for use were packaged into the final product. Class III Polymer Technology Systems, Inc. dba PTS Diagno...
Jan 21, 2020 PTS Detect Cotinine, Ref. No. 3061, UPC 381933061017 in vitro diagnostic - Pr... The firm is removing the product from the market after discussions with the FDA due to lack of 51... Class II Polymer Technology Systems, Inc.
Dec 2, 2019 Henry Schein CardioChek Plus Professional Analyzer, New Analyzer, boxed, with... One brand of batteries have a small dimensional difference in the negative button terminal, which... Class II Polymer Technology Systems, Inc.
Dec 2, 2019 PTS Diagnostics CardioChek Plus Professional Analyzer, Refurbished analyzer, ... One brand of batteries have a small dimensional difference in the negative button terminal, which... Class II Polymer Technology Systems, Inc.
Dec 2, 2019 Henry Schein CardioChek Starter Kit, Reference Number 4060 HS, 570-1036 One brand of batteries have a small dimensional difference in the negative button terminal, which... Class II Polymer Technology Systems, Inc.
Dec 2, 2019 PTS Diagnostics CardioChek Plus Professional Analyzer, New analyzer, boxed, w... One brand of batteries have a small dimensional difference in the negative button terminal, which... Class II Polymer Technology Systems, Inc.
Jun 7, 2019 Henry Schein Panels Lipid Panel test strip: IVD Lipid Panel Test Strips Re... The MEMo chips provided with lot P901 may be mislabeled, the MEMo Chip may display Q901 on the a... Class III Polymer Technology Systems, Inc.
Jun 7, 2019 PTS Panels Lipid Panel test strip: IVD Lipid Panel Test Strips Ref Number: ... The MEMo chips provided with lot P901 may be mislabeled, the MEMo Chip may display Q901 on the a... Class III Polymer Technology Systems, Inc.
Jan 16, 2019 Lipid Panel test strips, REF 1710, also private labeled under Henry Schein as... Some lots of test strips do not fit tightly into the optical block, and may fall out during analy... Class II Polymer Technology Systems, Inc.
Jan 16, 2019 Lipid Panel test strips (as a component of smart bundles), REF 2729, also pri... Some lots of test strips do not fit tightly into the optical block, and may fall out during analy... Class II Polymer Technology Systems, Inc.
Jan 16, 2019 CHOL+HDL+GLU test strips, REF 2412 Some lots of test strips do not fit tightly into the optical block, and may fall out during analy... Class II Polymer Technology Systems, Inc.
Mar 14, 2018 PTS Panels¿ CHOL+GLU Test Strips (REF 1765) Potential for loss of activity of the glucose analyte (under-recovery) prior to the full stated s... Class II Polymer Technology Systems, Inc.
Dec 2, 2016 Walgreens At-Home A1C Test Kit, Software Version Revision D, REF Number 3056 A numerical value less than 4% or greater than 13% may be displayed instead of the expected <4% o... Class II Polymer Technology Systems
Dec 2, 2016 ReliOn FastA1C Test, Software Version Revision D, REF Number 3055 A numerical value less than 4% or greater than 13% may be displayed instead of the expected <4% o... Class II Polymer Technology Systems
Dec 2, 2016 A1CNow+ Systems (professional use product), Software Version Revision D, REF ... A numerical value less than 4% or greater than 13% may be displayed instead of the expected <4% o... Class II Polymer Technology Systems
Dec 2, 2016 CVS Health At Home A1C Test Kit, Software Version Revision D, REF Number 3059 A numerical value less than 4% or greater than 13% may be displayed instead of the expected <4% o... Class II Polymer Technology Systems
Dec 2, 2016 A1CNow SELF CHECK (European), Software Version Revision D, REF Numbers 3054, ... A numerical value less than 4% or greater than 13% may be displayed instead of the expected <4% o... Class II Polymer Technology Systems
Mar 15, 2016 PTS Panels CHOL+HDL+GLU Test Strips, Reference Number 5412, for use on Cardio... This lot of test strips is showing an under-recovery when tested against a reference method. Class II Polymer Technology Systems, Inc.
Apr 4, 2013 PTS PANELS, Glucose Test Strips for use with CardioChek Brand Analyzers Pr... Internal investigation demonstrated under-recovery for glucose when tested against a reference me... Class II Polymer Technology Systems, Inc.
May 15, 2012 PTS Panels Creatinine test strips. PTS Panels Creatinine Test Strips are i... During a routine product investigation, a creatinine sample with a value less than 1.0 mg/dl was ... Class II Polymer Technology Systems, 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.