Browse Device Recalls

700 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 700 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 700 FDA device recalls.

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DateProductReasonClassFirm
Dec 7, 2022 IMMULITE 2000 Thyroglobulin (OUS). For in vitro diagnostic use with the IMMUL... Potential for Functional Sensitivity to not meet Instructions For Use (IFU) claims with the kit l... Class II Siemens Healthcare Diagnostics, Inc.
Dec 7, 2022 IMMULITE 2000 Thyroglobulin (US)- For in vitro diagnostic use with the IMMUL... Potential for Functional Sensitivity to not meet Instructions For Use (IFU) claims with the kit l... Class II Siemens Healthcare Diagnostics, Inc.
Nov 4, 2022 IMMULITE 2000 Systems 3gAllergy Specific IgE Universal Kit Tests OUS, excep... Potential for falsely elevated specific IgE mold allergen reactivity with quality control materia... Class II Siemens Healthcare Diagnostics, Inc.
Nov 4, 2022 IMMULITE 2000 Systems 3gAllergy Specific IgE Universal Kit Tests (600T)- US. ... Potential for falsely elevated specific IgE mold allergen reactivity with quality control materia... Class II Siemens Healthcare Diagnostics, Inc.
Nov 4, 2022 IMMULITE 2000 Systems 3gAllergy Specific IgE Universal Kit Tests Japan Sie... Potential for falsely elevated specific IgE mold allergen reactivity with quality control materia... Class II Siemens Healthcare Diagnostics, Inc.
Oct 25, 2022 IMMULITE and IMMULITE 1000 Total Testosterone Assay- In vitro diagnostic use ... Confirmed an average positive bias of 40% for testosterone concentrations of approximately 660 ng... Class II Siemens Healthcare Diagnostics, Inc.
Sep 19, 2022 Atellica CH Lithium_2 (LITH_2), Siemens Material Number 11532401. in vitro di... Potential for falsely elevated LITH_2 and Li results on the Atellica CH 930 Analyzer. In the wors... Class II Siemens Healthcare Diagnostics, Inc.
Sep 19, 2022 Atellica CH Lithium (Li), Siemens Material Number 11097535. in vitro diagnost... Potential for falsely elevated LITH_2 and Li results on the Atellica CH 930 Analyzer. In the wors... Class II Siemens Healthcare Diagnostics, Inc.
Aug 30, 2022 N Antiserum to Human IgG, 5mL Variant for BN II System and BN ProSpec System-... N Antiserum to Human IgG are not meeting the current High-Dose Hook Effect expectation of up to 6... Class II SIEMENS HEALTHCARE DIAGNOSTICS INC
Aug 30, 2022 N Antiserum to Human IgG, 2mL Variant for BN II System and BN ProSpec System-... N Antiserum to Human IgG are not meeting the current High-Dose Hook Effect expectation of up to 6... Class II SIEMENS HEALTHCARE DIAGNOSTICS INC
Aug 24, 2022 Dimension Vista High Density Lipoprotein Cholesterol (HDLC) Flex reagent cart... Dimension Vista¿ High Density Lipoprotein Cholesterol (HDLC) Potential for Erroneous Result. If a... Class II Siemens Healthcare Diagnostics, Inc.
Aug 17, 2022 Dimension Magnesium (MG) Flex reagent cartridge Siemens Material Number (SM... Dimension Magnesium (MG) Flex reagent cartridge lots may exhibit imprecision for Quality Control ... Class II Siemens Healthcare Diagnostics, Inc.
Aug 11, 2022 IMMULITE 2000 and IMMULITE 2000 XPi Thyroid Stimulating Immunoglobulins (TSI)... An average negative bias of -23% with IMMULITE 2000/IMMULITE 2000 XPi Thyroid Stimulating Immunog... Class II Siemens Healthcare Diagnostics, Inc.
Jul 18, 2022 Dimension Vista LOCI CA 15-3 Flex reagent cartridge. In Vitro Diagnostic for... Negative bias with patient samples. The mean patient sample bias range from -26% to -33%,potentia... Class II Siemens Healthcare Diagnostics, Inc.
Jun 28, 2022 Atellica CH Iron_2 (Iron_2) is for in vitro diagnostic use in the quantitativ... Falsely Elevated Atellica CH Microalbumin_2 (¿ALB_2) Results due to Reagent Carryover from the Ir... Class II Siemens Healthcare Diagnostics, Inc.
Jun 1, 2022 epoc BGEM Test Card 25 Test Cards/box. In vitro diagnostic device for the qu... Discrepant (low bias) pO2 results, could be an incorrect diagnosis of hypoxemia and initiation of... Class II Siemens Healthcare Diagnostics Inc
May 18, 2022 Dimension CTNI-In vitro diagnostic test intended to quantitively measure card... Positive bias with Lithium Heparin plasma samples from individuals that are expected to be below... Class II Siemens Healthcare Diagnostics, Inc.
May 18, 2022 Dimension LTNI -In vitro diagnostic test intended to quantitively measure car... Positive bias with Lithium Heparin plasma samples from individuals that are expected to be below... Class II Siemens Healthcare Diagnostics, Inc.
Apr 13, 2022 Atellica IM 1600 Analyzer - automated, immunoassay analyzer designed to perfo... Lots incompatible with Test Definition (TDef) Version 1.4, potentially lead to the generation of... Class II Siemens Healthcare Diagnostics, Inc.
Apr 13, 2022 Atellica IM 1300 Analyzer - automated, immunoassay analyzer designed to perfo... Lots incompatible with Test Definition (TDef) Version 1.4, potentially lead to the generation of... Class II Siemens Healthcare Diagnostics, Inc.
Mar 3, 2022 Atellica IM Enhanced Estradiol (eE2) 100T - In vitro diagnostic use in the qu... Falsely Elevated Results Observed with Plasma Specimens, could lead a clinician to misinterpret p... Class II Siemens Healthcare Diagnostics, Inc.
Mar 3, 2022 ADVIA Centaur Enhanced Estradiol (eE2) 100T - In vitro diagnostic use in the ... Falsely Elevated Results Observed with Plasma Specimens, could lead a clinician to misinterpret p... Class II Siemens Healthcare Diagnostics, Inc.
Mar 3, 2022 Atellica IM Enhanced Estradiol (eE2) 500T - In vitro diagnostic use in the qu... Falsely Elevated Results Observed with Plasma Specimens, could lead a clinician to misinterpret p... Class II Siemens Healthcare Diagnostics, Inc.
Mar 3, 2022 Atellica IM Enhanced Estradiol (eE2) (REF) 500T - In vitro diagnostic use in ... Falsely Elevated Results Observed with Plasma Specimens, could lead a clinician to misinterpret p... Class II Siemens Healthcare Diagnostics, Inc.
Mar 3, 2022 ADVIA Centaur Enhanced Estradiol (eE2) (REF) 500T - In vitro diagnostic use i... Falsely Elevated Results Observed with Plasma Specimens, could lead a clinician to misinterpret p... Class II Siemens Healthcare Diagnostics, Inc.
Mar 3, 2022 ADVIA Centaur Enhanced Estradiol (eE2) 500T - In vitro diagnostic use in the ... Falsely Elevated Results Observed with Plasma Specimens, could lead a clinician to misinterpret p... Class II Siemens Healthcare Diagnostics, Inc.
Feb 22, 2022 IMMULITE 2000 Systems HCG [200 Tests, material number 10381206, catalog numbe... Potential for falsely elevated hCG results due to sample carryover in serum and urine patient sa... Class II Siemens Healthcare Diagnostics, Inc.
Feb 9, 2022 Atellica CH Calcium_2 (CA_2), Siemens Material Number 11097644 Siemens Healthcare Diagnostics Inc. has confirmed the potential for reagent carryover impacting q... Class II Siemens Healthcare Diagnostics, Inc.
Feb 9, 2022 Atellica CH Enzymatic Hemoglobin A1c (A1c_E/A1c_H), Siemens Material Number 1... Siemens Healthcare Diagnostics Inc. has confirmed the potential for reagent carryover impacting q... Class II Siemens Healthcare Diagnostics, Inc.
Feb 9, 2022 Atellica CH Lithium_2 (LITH_2), Siemens Material Number 11097637 Siemens Healthcare Diagnostics Inc. has confirmed the potential for reagent carryover impacting q... Class II Siemens Healthcare Diagnostics, Inc.
Feb 9, 2022 Atellica CH Fructosamine (Fruc), Siemens Material Number 11097637 Siemens Healthcare Diagnostics Inc. has confirmed the potential for reagent carryover impacting q... Class II Siemens Healthcare Diagnostics, Inc.
Jan 28, 2022 Siemens Dimension Vista Magnesium Flex reagent cartridge (MG) Material # 104... Dimension Vista Magnesium Flex reagent cartridge lots exhibiting imprecision and intermittent Abn... Class II Siemens Healthcare Diagnostics, Inc.
Dec 1, 2021 Atellica CH ¿2-Microglobulin (B2M) -M) Assay for in vitro diagnostic use in t... ¿2 Microglobulin (B2M) Reagent Lot 211446 Bias with Quality Control and Patient Sample Results. P... Class II Siemens Healthcare Diagnostics, Inc.
Nov 18, 2021 Atellica CH 930 Analyzer with Software version: V1.25.1 and lower- An automat... (1)Software (SW) versions V1.25.1 and lower may result in TDef (Test Definition) Parameters for O... Class II Siemens Healthcare Diagnostics, Inc.
Oct 15, 2021 Dimension Vista 1500 In-vitro diagnostic device intended to duplicate manual ... Incorrect Default Hemolysis, Icterus or Lipemia (HIL) Index for Five Dimension Vista Assays Class II Siemens Healthcare Diagnostics, Inc.
Oct 15, 2021 Dimension Vista 500- In-vitro diagnostic device intended to duplicate manual ... Incorrect Default Hemolysis, Icterus or Lipemia (HIL) Index for Five Dimension Vista Assays Class II Siemens Healthcare Diagnostics, Inc.
Oct 6, 2021 Aptio Automation Interface Module to ADVIA Centaur XP/XPT. Aptio by Siemens C... The Aptio Automation Firmware for the ADVIA Centaur XP/XPT Interface Module may lead, in some cas... Class II Siemens Healthcare Diagnostics, Inc.
Sep 28, 2021 Atellica IM 1300 Analyzer, SMN 11066001 Ancillary reagent packs used on Atellica IM 1300 and Atellica IM 1600 analyzers may overflow when... Class II Siemens Healthcare Diagnostics, Inc
Sep 28, 2021 Atellica IM 1600 Analyzer, SMN 11066000 Ancillary reagent packs used on Atellica IM 1300 and Atellica IM 1600 analyzers may overflow when... Class II Siemens Healthcare Diagnostics, Inc
Sep 22, 2021 Atellica IM SARS-CoV-2 Antigen Assay (100 Test Kit), SMN # 11207861 Data provided in the Emergency Use Authorization (EUA) submission was insufficient to determine t... Class II Siemens Healthcare Diagnostics, Inc
Sep 22, 2021 ADVIA Centaur SARS-CoV-2 Antigen Assay (100 Test Kit), SMN # 11207866 Data provided in the Emergency Use Authorization (EUA) submission was insufficient to determine t... Class II Siemens Healthcare Diagnostics, Inc
Sep 20, 2021 Atellica CH Urinary/Cerebrospinal Fluid Protein (UCFP), SMN 11097543 The firm has confirmed the potential for Atellica CH Urinary/Cerebrospinal Fluid Protein reagent ... Class II Siemens Healthcare Diagnostics, Inc.
Sep 20, 2021 Advia Chemistry Urinary/Cerebrospinal Fluid Protein (UCFP), SMN 11319151 The firm has confirmed the potential for ADVIA Chemistry Urinary/Cerebrospinal Fluid Protein reag... Class II Siemens Healthcare Diagnostics, Inc.
Jul 6, 2021 Atellica IM BR 27.29 (BR) Assay 50 Test Kit- in vitro diagnostic use in the ... Product does not meet the Instructions for Use (IFU) claimed Pack Calibration Interval of 10 days... Class II Siemens Healthcare Diagnostics, Inc
Jul 6, 2021 Atellica IM BR 27.29 (BR) Assay 250 Test Kit (Reference)- in vitro diagnostic... Product does not meet the Instructions for Use (IFU) claimed Pack Calibration Interval of 10 days... Class II Siemens Healthcare Diagnostics, Inc
Jul 6, 2021 Atellica IM BR 27.29 (BR) Assay 250 Test Kit- in vitro diagnostic use in the ... Product does not meet the Instructions for Use (IFU) claimed Pack Calibration Interval of 10 days... Class II Siemens Healthcare Diagnostics, Inc
May 18, 2021 The ADVIA Chemistry XPT Chemistry System, Siemens Material Number (SMN) 10723... ADVIA Chemistry System and Software Versions (V1.4 SMN 11314625 and V1.4 China SMN 11316885) may ... Class II Siemens Healthcare Diagnostics, Inc.
May 13, 2021 Atellica CH 930 Analyzer - multi-component system for in vitro diagnostic te... Valves used on the Atellica CH 930, Atellica IM 1300 and Atellica IM 1600 analyzers may develop a... Class II Siemens Healthcare Diagnostics, Inc.
May 13, 2021 Atellica IM 1600 Analyzer- multi-component system for in vitro diagnostic te... Valves used on the Atellica CH 930, Atellica IM 1300 and Atellica IM 1600 analyzers may develop a... Class II Siemens Healthcare Diagnostics, Inc.
May 13, 2021 Atellica IM 1300 Analyzer - multi-component system for in vitro diagnostic t... Valves used on the Atellica CH 930, Atellica IM 1300 and Atellica IM 1600 analyzers may develop a... 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.