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
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.
Oct 17, 2017 BC Thrombin Reagent Kit Lot Number 46751; UDI - 008427680131024675120180908 a... The BC Thrombin Reagent kit lot 46751 (contains Thrombin Reagent lot 517468) and kit lot 47184 (c... Class II Siemens Healthcare Diagnostics
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.
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.
Jun 7, 2017 ADVIA Centaur Calibrator 30, 2 pack, 6 pack, and Ref 2 pack. Siemens Materia... Siemens Healthcare Diagnostics has confirmed a negative bias for ADVIA Centaur Enhanced Estradiol... Class II Siemens Healthcare Diagnostics, Inc
Jun 5, 2017 SIEMENS N Protein Standard SL, for use on the BN II, BN ProSpec Systems, REF/... Siemens Healthcare Diagnostics has confirmed a negative bias of approximately -20% for results ob... Class II CSL Behring GmbH
Jun 5, 2017 SIEMENS N/T Protein Control SL for use on the BN II, BN ProSpec Systems: N/T ... Siemens Healthcare Diagnostics has confirmed a negative bias of approximately -20% for results ob... Class II CSL Behring GmbH
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.
Apr 10, 2017 RAPIDPoint¿ 500 Blood Gas Analyzer with v2.4 software for professional use in... Potential Patient Demographic Error with Blank Patient ID Field Class II Siemens Healthcare Diagnostics Inc
Apr 5, 2017 ADVIA Centaur Systems Insulin Calibrator; Test Code: Calibrator IRI; Catalog ... Current lots of ADVIA Centaur/XP/XPT/CP Insulin (IRI) assay recover approximately 40% higher than... Class II Siemens Healthcare Diagnostics, Inc
Apr 5, 2017 ADVIA Centaur Systems Insulin ReadyPack; Test Code: IRI; Catalog Number: 0223... Current lots of ADVIA Centaur/XP/XPT/CP Insulin (IRI) assay recover approximately 40% higher than... 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.

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.