Browse Device Recalls

580 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 580 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 580 FDA device recalls.

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DateProductReasonClassFirm
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.
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.
Jan 2, 2018 ADVIA Centaur¿ HBc IgM 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¿ Mass Creatine Kinase (MMB) 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 Dimension¿ Free Thyroxine (FT4L) 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 Anti HBc 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 Gastrin 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¿ DHEA-SO4 The concentrations for biotin listed in the non-interfering substances section of the instruction... Class II Siemens Healthcare Diagnostics, Inc.
Jan 2, 2018 IMMULITE ¿ /IMMULITE ¿ 1000 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 IMMULITE ¿ /IMMULITE ¿ 1000 BR-MA (CA15-3) 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 ¿ Gastrin 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 BR-MA (CA15-3) Concentrations for the level of biotin that does not interfere is not currently listed in the ins... Class II Siemens Healthcare Diagnostics, Inc.
Dec 18, 2017 ADVIA Centaur BNP (B-type Natriuretic Peptide), Catalog Numbers: 02816138 (10... In certain scenarios the ADVIA Centaur CP, XP and XPT immunoassay analyzers may exhibit reduced d... Class II Siemens Healthcare Diagnostics, Inc.
Dec 18, 2017 ADVIA Centaur TSH3-Ultra (Thyroid Stimulating Hormone 3 Ultra), Catalog Numbe... In certain scenarios the ADVIA Centaur CP, XP and XPT immunoassay analyzers may exhibit reduced d... Class II Siemens Healthcare Diagnostics, Inc.
Dec 14, 2017 Dimension Lipase Flex¿ Reagent Cartridge - ( Lipase-esterase, enzymatic, pho... Calibration failure - confirmed a positive bias with LIPL lot FB8109 when compared to other Dimen... Class II Siemens Healthcare Diagnostics, Inc.
Nov 27, 2017 Syva¿ EMIT¿ 2000 Theophylline Product Usage: The Syva¿ Emit¿ 2000 Theophy... Lot J1 of the Syva¿ EMIT¿ 2000 Theophylline Assay, when run on a Beckman AU Clinical Chemistry S... Class II Siemens Healthcare Diagnostics, Inc.
Nov 9, 2017 Dimension Vista System LOCI 8 CALIBRATOR The LOCI 8 Calibrator is an in v... An increase in the number of failed calibration events or negative bias with Quality Control (QC)... Class II Siemens Healthcare Diagnostics, Inc.
Jul 28, 2017 ADVIA Centaur¿ T3 ADVIA Centaur T3: For in vitro diagnostic use in the qua... Siemens has identified an issue when scanning the 20 barcode for the Master Curve Card (MCC) wit... Class II Siemens Healthcare Diagnostics, Inc
Jun 29, 2017 Dimension Vista Ammonia (AMM) assay (Product Number: K3119/10711992) (Mfr: Si... Various assays used to measure different chemical levels in blood, urine, or cerebrospinal fluid ... Class II Siemens Healthcare Diagnostics, Inc.
Jun 29, 2017 Dimension Alanine Aminotransferase (ALTI) assay; (Product Number: DF143/10475... Various assays used to measure different chemical levels in blood, urine, or cerebrospinal fluid ... Class II Siemens Healthcare Diagnostics, Inc.
Jun 29, 2017 Dimension Vista Alanine Aminotransferase (ALTI) assay; (Product Number: K2143... Various assays used to measure different chemical levels in blood, urine, or cerebrospinal fluid ... 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.