Browse Device Recalls

454 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 454 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 454 FDA device recalls.

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DateProductReasonClassFirm
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.
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.
Jun 29, 2017 Dimension Vista Glucose (GLU) assay; (Product Number: K1039/10445162) (Mfr: S... Various assays used to measure different chemical levels in blood, urine, or cerebrospinal fluid ... Class II Siemens Healthcare Diagnostics, Inc.
Jun 29, 2017 Dimension Creatine Kinase MB (MBI) assay (Product Number: DF32/10464510) (Mfr... Various assays used to measure different chemical levels in blood, urine, or cerebrospinal fluid ... Class II Siemens Healthcare Diagnostics, Inc.
Jun 29, 2017 Syva Emit 2000 Tacrolimus Assay (Product Number: 8R019UL/10445397) (Mfr: Siem... 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 Aspartate Aminotransferase (AST) assay; (Product Number: K201... Various assays used to measure different chemical levels in blood, urine, or cerebrospinal fluid ... Class II Siemens Healthcare Diagnostics, Inc.
Jun 29, 2017 Syva Emit 2000 Sirolimus Assay (Product Number: 8S019UL/10445401) (Mfr: Sieme... 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 Creatine Kinase MB (MBI) assay; (Product Number: K3032/104643... Various assays used to measure different chemical levels in blood, urine, or cerebrospinal fluid ... Class II Siemens Healthcare Diagnostics, Inc.
Jun 29, 2017 Dimension Ammonia (AMM) assay; (Product Number: DF119/10711991) (Mfr: Siemens... Various assays used to measure different chemical levels in blood, urine, or cerebrospinal fluid ... Class II Siemens Healthcare Diagnostics, Inc.
Jun 29, 2017 Dimension Glucose (GLUC) assay (Product Number: DF40/10444973) (Mfr: Siemens ... Various assays used to measure different chemical levels in blood, urine, or cerebrospinal fluid ... Class II Siemens Healthcare Diagnostics, Inc.
Jun 29, 2017 ADVIA Salicylate (SAL) reagent chemistry assay; use in the quantitative dete... Various assays used to measure different chemical levels in blood, urine, or cerebrospinal fluid ... Class II Siemens Healthcare Diagnostics, Inc.
Jun 29, 2017 Dimension Aspartate Aminotransferase (AST) assay (Product Number: DF41A/10444... Various assays used to measure different chemical levels in blood, urine, or cerebrospinal fluid ... Class II Siemens Healthcare Diagnostics, Inc.
Jun 29, 2017 ADVIA Ammonia (AMM) chemistry assay, an in vitro diagnostic device intended t... Various assays used to measure different chemical levels in blood, urine, or cerebrospinal fluid ... Class II Siemens Healthcare Diagnostics, Inc.
Jun 29, 2017 Dimension Thyroxine (T4) assay (Product Number: DF65/10444908) (Mfr: Siemens ... 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 Thyroxine (T4) assay; (Product Number: K6065/10445101) (Mfr: ... Various assays used to measure different chemical levels in blood, urine, or cerebrospinal fluid ... Class II Siemens Healthcare Diagnostics, Inc.
Jun 29, 2017 ADVIA Alanine Aminotransferase (ALT) reagent chemistry assays; ALT intended t... Various assays used to measure different chemical levels in blood, urine, or cerebrospinal fluid ... Class II Siemens Healthcare Diagnostics, Inc.
May 23, 2017 Dimension Vista Protein 1 Control, PROT 1 CON L, Siemens Material Number (SMN... Complaint of high amount of ceruloplasmin patient results below the reference range (< 20 mg/dL [... Class II Siemens Healthcare Diagnostics, Inc.
May 23, 2017 Dimension Vista Protein 1 Calibrator, PROT 1 CAL, Siemens Material Number (SM... Complaint of high amount of ceruloplasmin patient results below the reference range (< 20 mg/dL [... Class II Siemens Healthcare Diagnostics, Inc.
May 23, 2017 Dimension Vista Protein 1 Control H, PROT 1 CON H, Siemens Material Number (S... Complaint of high amount of ceruloplasmin patient results below the reference range (< 20 mg/dL [... Class II Siemens Healthcare Diagnostics, Inc.
May 23, 2017 Dimension Vista Protein 1 Control M, PROT 1 CON M, Siemens Material Number (S... Complaint of high amount of ceruloplasmin patient results below the reference range (< 20 mg/dL [... Class II Siemens Healthcare Diagnostics, Inc.
Mar 21, 2017 Dimension Troponin 1 (TNI) Flex reagent cartridge The concentrations for Biotin listed in the Non-Interfering Substances section of the current Dim... Class II Siemens Healthcare Diagnostics, Inc.
Mar 21, 2017 Dimension Vista Ferritin (FERR) Flex reagent cartridge The concentrations for Biotin listed in the Non-Interfering Substances section of the current Dim... Class II Siemens Healthcare Diagnostics, Inc.
Mar 21, 2017 Dimension Vista Estradiol (E2) Flex reagent cartridge The concentrations for Biotin listed in the Non-Interfering Substances section of the current Dim... Class II Siemens Healthcare Diagnostics, Inc.
Mar 21, 2017 Dimension Vista Digoxin (DIGXN) Flex reagent cartridge The concentrations for Biotin listed in the Non-Interfering Substances section of the current Dim... Class II Siemens Healthcare Diagnostics, Inc.
Mar 21, 2017 Dimension Vista Prolactin (PRL) Flex reagent cartridge The concentrations for Biotin listed in the Non-Interfering Substances section of the current Dim... Class II Siemens Healthcare Diagnostics, Inc.
Mar 21, 2017 Dimension Vista Thyroid Stimulating Hormone (TSH) Flex reagent cartridge The concentrations for Biotin listed in the Non-Interfering Substances section of the current Dim... Class II Siemens Healthcare Diagnostics, Inc.
Mar 3, 2017 Dimension Vista 500 Intelligent Lab System and Dimension Vista 1500 Intellige... Siemens Healthcare Diagnostics has confirmed that in isolated cases when ECREA is processed immed... Class II Siemens Healthcare Diagnostics, Inc.
Feb 23, 2017 ADVIA Chemistry Enzyme 2 Calibrator, multi-analyte mixture Product Usage: ... Siemens Healthcare Diagnostics has confirmed a positive bias of up to 41% in quality control and ... Class III Siemens Healthcare Diagnostics, Inc.
Feb 2, 2017 ADVIA Centaur XPT System Software Versions V1.0.1, V1.0.2, V1.0.3, V1.1 and V... Multiple software issues, which may affect the operation and workflow of the system. Potential fo... Class II Siemens Healthcare Diagnostics, Inc.
Jan 31, 2017 SHBG IMMULITE 2000/IMMULITE 2000 XPi For the in vitro diagnostic use with th... Certain lots of Sex Hormone Binding Globulin (SHBG) do not meet the thirty (30) day open vial adj... Class II Siemens Healthcare Diagnostics, Inc.
Jan 11, 2017 N Latex HCY REAGENT, REF/Catalog OPAX03 /SMN 10445973 , IVD Product Usag... The firm confirmed a reduced once-opened and on-board stability for N Latex Homocysteine (HCY) OP... Class II Siemens Healthcare Diagnostics, Inc.
Dec 21, 2016 IMMULITE/IMMULITE 1000 Systems, Third Generation PSA, Catalog Number/REF LKUP... Negative bias with IMMULITE¿ /IMMULITE¿ 1000 Third Generation PSA (prostate-specific antigen) kit... Class II Siemens Healthcare Diagnostics, Inc.
Dec 21, 2016 IMMULITE/IMMULITE 1000 Systems, Third Generation PSA, Catalog Number/REF LK3P... Negative bias results with the IMMULITE¿ /IMMULITE¿ 1000 Third Generation PSA (prostate-specific ... Class II Siemens Healthcare Diagnostics, Inc.
Dec 16, 2016 Dimension Vista¿ Ammonia Flex¿ reagent cartridge / AMM Dimension: The AMM me... Siemens Healthcare Diagnostics has determined that Dimension Vista AMM (K3119) Flex reagent cartr... Class II Siemens Healthcare Diagnostics, Inc.
Dec 16, 2016 Dimension¿ Ammonia Flex¿ reagent cartridge / AMM Dimension: The AMM method ... Siemens Healthcare Diagnostics has determined that Dimension AMM (DF119) flex reagent cartridge l... 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.