Browse Device Recalls

688 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 688 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 688 FDA device recalls.

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DateProductReasonClassFirm
Aug 14, 2018 APTIO RACK OUTPUT MODULE The modules may have been shipped without a warning label for potential risk of interference to p... Class II Siemens Healthcare Diagnostics, Inc.
Aug 14, 2018 STREAMLAB - REFRIGERATED STORAGE MODULE 15000 The modules may have been shipped without a warning label for potential risk of interference to p... Class II Siemens Healthcare Diagnostics, Inc.
Aug 14, 2018 STREAMLAB - REFRIGERATED STORAGE MODULE 9000 The modules may have been shipped without a warning label for potential risk of interference to p... Class II Siemens Healthcare Diagnostics, Inc.
Aug 14, 2018 APTIO INPUT/OUTPUT MODULE The modules may have been shipped without a warning label for potential risk of interference to p... Class II Siemens Healthcare Diagnostics, Inc.
Aug 14, 2018 STREAMLAB CORE UNIT / LYNX WITH IOM The modules may have been shipped without a warning label for potential risk of interference to p... Class II Siemens Healthcare Diagnostics, Inc.
Aug 14, 2018 APTIO RACK INPUT MODULE The modules may have been shipped without a warning label for potential risk of interference to p... Class II Siemens Healthcare Diagnostics, Inc.
Aug 14, 2018 APTIO 15000 REFRIGERATED STORAGE MODULE The modules may have been shipped without a warning label for potential risk of interference to p... Class II Siemens Healthcare Diagnostics, Inc.
Jul 24, 2018 ADVIA Centaur CKMB Calibrator 2-pack Japan, Cat No. 02562748 Product Usage... A potential bias was identified with certain kits compared to the internal standards. Class II Siemens Healthcare Diagnostics, Inc
Jul 24, 2018 ADVIA Centaur CKMB Master Curve Material, Cat No. 07867768 Product Usage: ... A potential bias was identified with certain kits compared to the internal standards. Class II Siemens Healthcare Diagnostics, Inc
Jul 24, 2018 Atellica IM CKMB Master Curve Material, Cat No. 10995534 Product Usage: ... A potential bias was identified with certain kits compared to the internal standards. Class II Siemens Healthcare Diagnostics, Inc
Jul 24, 2018 ADVIA Centaur CKMB Calibrator, Cat No. 09318028 Product Usage: For in vit... A potential bias was identified with certain kits compared to the internal standards. Class II Siemens Healthcare Diagnostics, Inc
Jul 24, 2018 Atellica IM CKMB Calibrator, Cat No. 10995532 Product Usage: For in vit... A potential bias was identified with certain kits compared to the internal standards. Class II Siemens Healthcare Diagnostics, Inc
Jul 16, 2018 RAPIDPoint 405 Blood Gas Analyzer; 10282093, 10310464, 10314817, 10317193, 10... Therapeutic levels (1mg/mL and 2mg/mL) of Hydroxocobalamin may interfere with tHb and some of the... Class II Siemens Healthcare Diagnostics, Inc.
Jul 16, 2018 RAPIDPoint 500 Blood Gas Analyzer; 10492730, 1069855, 10696857, 10697306 ... Therapeutic levels (1mg/mL and 2mg/mL) of Hydroxocobalamin may interfere with tHb and some of the... Class II Siemens Healthcare Diagnostics, Inc.
Jul 16, 2018 RAPIDLab 1245 Blood Gas Analyzer; 10321844, 10337179, 10491393 Device is ... Therapeutic levels (1mg/mL and 2mg/mL) of Hydroxocobalamin may interfere with tHb and some of the... Class II Siemens Healthcare Diagnostics, Inc.
Jul 16, 2018 RAPIDLab 1265 Blood Gas Analyzer; 110321852, 10470366, 10491395 Device is... Therapeutic levels (1mg/mL and 2mg/mL) of Hydroxocobalamin may interfere with tHb and some of the... Class II Siemens Healthcare Diagnostics, Inc.
Jun 29, 2018 Atellica IM 1300 Analyzer (SMN 11066001). The Atellica" Solution is a mult... Atellica Solution system software (SW) version 1.13 and lower, five (5) behavioral issues were id... Class II Siemens Healthcare Diagnostics, Inc.
Jun 29, 2018 Atellica CH 930 Analyzer (SMN 11067000) . The Atellica" Solution is a multi-... Atellica Solution system software (SW) version 1.13 and lower, five (5) behavioral issues were id... Class II Siemens Healthcare Diagnostics, Inc.
Jun 29, 2018 Atellica Sample Handler Connect (SMN 11069018). The Atellica" Solution is a ... Atellica Solution system software (SW) version 1.13 and lower, five (5) behavioral issues were id... Class II Siemens Healthcare Diagnostics, Inc.
Jun 29, 2018 Atellica Sample Handler Additional (SMN 11069004). The Atellica" Solution ... Atellica Solution system software (SW) version 1.13 and lower, five (5) behavioral issues were id... Class II Siemens Healthcare Diagnostics, Inc.
Jun 29, 2018 Atellica IM 1600 Analyzer (SMN 11066000). The Atellica" Solution is a multi-... Atellica Solution system software (SW) version 1.13 and lower, five (5) behavioral issues were id... Class II Siemens Healthcare Diagnostics, Inc.
Jun 29, 2018 Atellica Sample Handler Prime (SMN 11069001). The Atellica" Solution is a ... Atellica Solution system software (SW) version 1.13 and lower, five (5) behavioral issues were id... Class II Siemens Healthcare Diagnostics, Inc.
May 31, 2018 N Latex CDT Kit Siemens Healthcare Diagnostics has observed a negative bias for the carbohydrate-deficient transf... Class II CSL Behring GmbH
Apr 19, 2018 Dimension Vista Gentamicin Flex reagent cartridge, DV GENT, gentamicin enzyme... The affected lots may exhibit inaccuracy for Quality Control and patient samples at the low end o... Class II Siemens Healthcare Diagnostics, Inc.
Apr 19, 2018 Dimension Gentamicin Flex reagent cartridge, DM GENT, gentamicin enzyme immu... The affected lots may exhibit inaccuracy for Quality Control and patient samples at the low end o... Class II Siemens Healthcare Diagnostics, Inc.
Mar 27, 2018 ADVIA Chemistry Urea Nitrogen Reagent (material number 10309051) for use on A... Urea Nitrogen reagent kit demonstrated an increased incidence of Calibration Failures. Results ca... Class II Siemens Healthcare Diagnostics, Inc.
Mar 21, 2018 Dimension Vista¿ CTNI Sample Diluent, KD692, SMN# 10445205 The diluent may have an incomplete slit on the septum in the cap of the vial. A diluent cap with... Class II Siemens Healthcare Diagnostics, Inc.
Mar 21, 2018 Dimension Vista¿ MULTI 1 SDIL, KD693, SMN# 10469971 The diluent may have an incomplete slit on the septum in the cap of the vial. A diluent cap with... Class II Siemens Healthcare Diagnostics, Inc.
Mar 21, 2018 Dimension Vista¿ MULTI 2 SDIL, KD694, SMN# 10483586 The diluent may have an incomplete slit on the septum in the cap of the vial. A diluent cap with... Class II Siemens Healthcare Diagnostics, Inc.
Mar 12, 2018 Syva¿ EMIT¿ II Plus 6-Acetylmorphine Catalog # for 1000 mL: 9R129UL /SMN# 10... Incorrect calibrator level listed in qualitative calibration steps Class III Siemens Healthcare Diagnostics, Inc.
Mar 12, 2018 Syva¿ EMIT¿ II Plus 6-Acetyl morphine Catalog # for 28 mL: 9R039UL /SMN# 104... Incorrect calibrator level listed in qualitative calibration steps Class III Siemens Healthcare Diagnostics, Inc.
Feb 26, 2018 Atellica Solution and Atellica Sample Handler Prime for in vitro diagnostic t... When more than one immunoassay analyzer is connected to a single solution system, reporting and c... Class II Siemens Healthcare Diagnostics, Inc.
Feb 26, 2018 Atelia IM 1300 Analyzer for in vitro diagnostic testing of clinical specimens. When more than one immunoassay analyzer is connected to a single solution system, reporting and c... Class II Siemens Healthcare Diagnostics, Inc.
Feb 26, 2018 Analyzer and Atellica IM 1600 Analyzer system for in vitro diagnostic testing... When more than one immunoassay analyzer is connected to a single solution system, reporting and c... Class II Siemens Healthcare Diagnostics, Inc.
Feb 21, 2018 ADVIA Centaur CA 125II Assay; Cat No. 09427226, SMN 10310443 (1-pack/100 test... Upon dilution, some patient samples may exhibit over-recovery outside the representative data pro... Class II Siemens Healthcare Diagnostics, Inc
Jan 30, 2018 Dimension Vista¿ Calcium Flex¿ reagent cartridge, Dimension Vista¿ CA, K1023,... May produce erroneously low results from specific well sets. Class II Siemens Healthcare Diagnostics, Inc.
Jan 2, 2018 ADVIA Centaur¿ Folate (FOL) Concentrations for the level of biotin that does not interfere is not currently listed in the ins... Class II Siemens Healthcare Diagnostics, Inc.
Jan 2, 2018 IMMULITE ¿ /IMMULITE ¿ 1000 TG Concentrations for the level of biotin that does not interfere is not currently listed in the ins... Class II Siemens Healthcare Diagnostics, Inc.
Jan 2, 2018 Dimension Vista¿ Cardiac Troponin I (CTNI) Flex¿ reagent cartridge Concentrations for the level of biotin that does not interfere is not currently listed in the ins... Class II Siemens Healthcare Diagnostics, Inc.
Jan 2, 2018 IMMULITE ¿ 2000/IMMULITE ¿ 2000 XPi TG Concentrations for the level of biotin that does not interfere is not currently listed in the ins... Class II Siemens Healthcare Diagnostics, Inc.
Jan 2, 2018 IMMULITE 2000/IMMULITE ¿ 2000 XPi OM-MA (CA125) Concentrations for the level of biotin that does not interfere is not currently listed in the ins... Class II Siemens Healthcare Diagnostics, Inc.
Jan 2, 2018 Dimension¿ Thyroid Stimulating Hormone (TSHL) Flex¿ reagent cartridge The concentrations for biotin listed in the non-interfering substances section of the instruction... Class II Siemens Healthcare Diagnostics, Inc.
Jan 2, 2018 IMMULITE ¿ 2000/IMMULITE ¿ 2000 XPi 3g Allergy specific IgE Universal Kit Concentrations for the level of biotin that does not interfere is not currently listed in the ins... Class II Siemens Healthcare Diagnostics, Inc.
Jan 2, 2018 IMMULITE ¿ /IMMULITE ¿ 1000 Vitamin B12 Concentrations for the level of biotin that does not interfere is not currently listed in the ins... Class II Siemens Healthcare Diagnostics, Inc.
Jan 2, 2018 ADVIA Centaur¿ Cyclosporine The concentrations for biotin listed in the non-interfering substances section of the instruction... Class II Siemens Healthcare Diagnostics, Inc.
Jan 2, 2018 IMMULITE ¿ 2000/IMMULITE ¿ 2000 XPi Folic Acid Concentrations for the level of biotin that does not interfere is not currently listed in the ins... Class II Siemens Healthcare Diagnostics, Inc.
Jan 2, 2018 Dimension Vista¿ Thyroid Stimulating Hormone (TSH) Flex¿ reagent cartridge The concentrations for biotin listed in the non-interfering substances section of the instruction... Class II Siemens Healthcare Diagnostics, Inc.
Jan 2, 2018 Dimension¿ Sirolimus (SIRO) Flex¿ reagent cartridge Concentrations for the level of biotin that does not interfere is not currently listed in the ins... Class II Siemens Healthcare Diagnostics, Inc.
Jan 2, 2018 IMMULITE ¿ 2000/IMMULITE ¿ 2000 XPi CEA Concentrations for the level of biotin that does not interfere is not currently listed in the ins... Class II Siemens Healthcare Diagnostics, Inc.
Jan 2, 2018 IMMULITE ¿ /IMMULITE ¿ 1000 CEA Concentrations for the level of biotin that does not interfere is not currently listed in the ins... Class II Siemens Healthcare Diagnostics, 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.