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.

Clear
DateProductReasonClassFirm
Jan 24, 2024 ADVIA Centaur Erythropoietin (EPO) Assay (100 Test) Siemens Healthcare Diagnostics has confirmed an average negative bias of -35% compared to the 3rd... Class II Siemens Healthcare Diagnostics, Inc.
Jan 24, 2024 Atellica IM Erythropoietin (EPO) Assay (100 Test) Siemens Healthcare Diagnostics has confirmed an average negative bias of -35% compared to the 3rd... Class II Siemens Healthcare Diagnostics, Inc.
Dec 15, 2023 Total immunoglobulin M (IgM total) IVD, kit, nephelometry/turbidimetry Potential for a negative bias with quality control (QC) and patient sample results when using the... Class II Siemens Healthcare Diagnostics, Inc.
Oct 26, 2023 RAPIDPoint 500 Systems Measurement Cartridge (with Lactate) 100 -Intended fo... RAPIDPoint 500 Systems Measurement Cartridges (with lactate) has the potential to affect the Sodi... Class II Siemens Healthcare Diagnostics Inc
Oct 26, 2023 RAPIDPoint 500 Systems Measurement Cartridge (with Lactate) 750-Intended for ... RAPIDPoint 500 Systems Measurement Cartridges (with lactate) has the potential to affect the Sodi... Class II Siemens Healthcare Diagnostics Inc
Oct 26, 2023 RAPIDPoint 500 Systems Measurement Cartridge (with Lactate) 400-Intended for ... RAPIDPoint 500 Systems Measurement Cartridges (with lactate) has the potential to affect the Sodi... Class II Siemens Healthcare Diagnostics Inc
Oct 26, 2023 RAPIDPoint 500 Systems Measurement Cartridge (with Lactate) 250-Intended for ... RAPIDPoint 500 Systems Measurement Cartridges (with lactate) has the potential to affect the Sodi... Class II Siemens Healthcare Diagnostics Inc
Oct 19, 2023 epoc NXS Host Blood Analysis System, Siemens Material Numbers 11413497 (EU), ... Siemens Healthcare Diagnostics Inc. has confirmed a potential issue that could occur under certai... Class II Siemens Healthcare Diagnostics Inc
Sep 26, 2023 RAPIDPOINT 500e Blood Gas System There are potential drug interferences from Perhexiline Maleate or Atomoxetine Hydrochloride that... Class II Siemens Healthcare Diagnostics Inc
Sep 26, 2023 RAPIDPOINT 500 Blood Gas System There are potential drug interferences from Perhexiline Maleate or Atomoxetine Hydrochloride that... Class II Siemens Healthcare Diagnostics Inc
Aug 8, 2023 ADVIA Chemistry Iron_2 (IRON_2) Reagents, Material Numbers 10377510 (6 x 350 ... There is a potential for a positive bias on Quality Control (QC) and patient sample results when ... Class II Siemens Healthcare Diagnostics, Inc.
Jul 25, 2023 ADVIA Chemistry Urinary/Cerebrospinal Fluid Protein (UCFP), Material Number 1... There is a potential for ADVIA Chemistry Urinary/Cerebrospinal Fluid Protein reagent carryover im... Class II Siemens Healthcare Diagnostics, Inc.
Jul 10, 2023 Atellica CH LDL Cholesterol- In vitro diagnostic use in the quantitative det... Potential for reagent carryover on the Atellica CH 930 resulting in a positive bias that could im... Class II Siemens Healthcare Diagnostics, Inc.
Jul 10, 2023 Atellica CH Total Bilirubin_2 -In vitro diagnostic use in the quantitative d... Potential for reagent carryover on the Atellica CH 930 resulting in a positive bias that could im... Class II Siemens Healthcare Diagnostics, Inc.
Jul 10, 2023 Atellica¿ CH HDL Cholesterol- In vitro diagnostic use in the quantitative d... Potential for reagent carryover on the Atellica CH 930 resulting in a positive bias that could im... Class II Siemens Healthcare Diagnostics, Inc.
Jul 10, 2023 Atellica CH Gamma-Glutamyl Transferase-IIn vitro diagnostic use in the quanti... Potential for reagent carryover on the Atellica CH 930 resulting in a positive bias that could im... Class II Siemens Healthcare Diagnostics, Inc.
Jun 1, 2023 epoc BGEM BUN Test Card with epoc Host SW v3.37.3, epoc NXS SW v4.10.6, Senso... There is potential for discrepant high glucose results in samples with glucose results on the low... Class II Siemens Healthcare Diagnostics Inc
Jun 1, 2023 epoc BGEM Test Card (BUN & TCO2),Veterinary with epoc Host SW v3.37.3, epoc N... There is potential for discrepant high glucose results in samples with glucose results on the low... Class II Siemens Healthcare Diagnostics Inc
Jun 1, 2023 epoc BGEM Crea Test Card with epoc Host SW v3.37.3, epoc NXS SW v4.10.6, Sens... There is potential for discrepant high glucose results in samples with glucose results on the low... Class II Siemens Healthcare Diagnostics Inc
May 16, 2023 Aptio Automation Storage and Retrieval Module (SRM) A firmware error may lead to an incorrect association of test result(s) to a sample ID and theref... Class II Siemens Healthcare Diagnostics, Inc.
Apr 5, 2023 ADVIA Chemistry ToxAmmonia Calibrator- In vitro diagnostic use in the calibra... Reassignment of the Atellica CH Toxicology Calibrators (TOX CAL) and ADVIA Chemistry ToxAmmonia C... Class II Siemens Healthcare Diagnostics, Inc.
Apr 5, 2023 Atellica CH Toxicology Calibrator (TOX CAL)-The Atellica¿ CH Toxicology Calib... Reassignment of the Atellica CH Toxicology Calibrators (TOX CAL) and ADVIA Chemistry ToxAmmonia C... Class II Siemens Healthcare Diagnostics, Inc.
Mar 16, 2023 ADVIA Centaur Cortisol 50T (Material Number 10994924), ADVIA Centaur Cortisol... There is a negative bias with urine patient samples and urine cortisol Quality Control (QC) resul... Class II Siemens Healthcare Diagnostics, Inc.
Mar 16, 2023 Atellica IM Cortisol 50T (Material Number 10995538), 250T (Material Number 10... There is a negative bias with urine patient samples and urine cortisol Quality Control (QC) resul... Class II Siemens Healthcare Diagnostics, Inc.
Jan 30, 2023 Dimension Tacrolimus (TAC) Flex reagent cartridge-In vitro diagnostic test fo... Siemens Healthineers has received customer complaints and confirmed imprecision for Quality Contr... Class II Siemens Healthcare Diagnostics, Inc.
Jan 27, 2023 Atellica CH Triglycerides_2: in vitro diagnostic use in the quantitative dete... Reagent Carryover from LDL Cholesterol Direct (DLDL), Total Protein II (TP), Triglycerides (Trig)... Class II Siemens Healthcare Diagnostics, Inc.
Jan 27, 2023 Atellica CH Total Protein II- In vitro diagnostic use in the quantitative det... Reagent Carryover from LDL Cholesterol Direct (DLDL), Total Protein II (TP), Triglycerides (Trig)... Class II Siemens Healthcare Diagnostics, Inc.
Jan 27, 2023 Atellica CH LDL Cholesterol Direct (DLDL)-In vitro diagnostic quantitative de... Reagent Carryover from LDL Cholesterol Direct (DLDL), Total Protein II (TP), Triglycerides (Trig)... Class II Siemens Healthcare Diagnostics, Inc.
Jan 27, 2023 Atellica CH Triglycerides (concentrated)-In vitro diagnostic use in the quant... Reagent Carryover from LDL Cholesterol Direct (DLDL), Total Protein II (TP), Triglycerides (Trig)... Class II Siemens Healthcare Diagnostics, Inc.
Jan 9, 2023 ADVIA Centaur Folate 500 test kit- For in vitro diagnostic use in the quantit... Negative bias occurred when whole blood calibration (Atellica IM Fol or ADVIA Centaur FolateBA/Fo... Class II Siemens Healthcare Diagnostics, Inc.
Jan 9, 2023 ADVIA Centaur Folate 500 test kit (REF)-For in vitro diagnostic use in the qu... Negative bias occurred when whole blood calibration (Atellica IM Fol or ADVIA Centaur FolateBA/Fo... Class II Siemens Healthcare Diagnostics, Inc.
Jan 9, 2023 Atellica IM Folate 700 test kit- For in vitro diagnostic use in the quantitat... Negative bias occurred when whole blood calibration (Atellica IM Fol or ADVIA Centaur FolateBA/Fo... Class II Siemens Healthcare Diagnostics, Inc.
Jan 9, 2023 ADVIA Centaur Folate 100 test kit-For in vitro diagnostic use in the quantita... Negative bias occurred when whole blood calibration (Atellica IM Fol or ADVIA Centaur FolateBA/Fo... Class II Siemens Healthcare Diagnostics, Inc.
Jan 9, 2023 Atellica IM Folate 700 test kit (REF)-For in vitro diagnostic use in the quan... Negative bias occurred when whole blood calibration (Atellica IM Fol or ADVIA Centaur FolateBA/Fo... Class II Siemens Healthcare Diagnostics, Inc.
Jan 9, 2023 Atellica IM Folate 140 test kit- For in vitro diagnostic use in the quantitat... Negative bias occurred when whole blood calibration (Atellica IM Fol or ADVIA Centaur FolateBA/Fo... Class II Siemens Healthcare Diagnostics, Inc.
Dec 22, 2022 ADVIA Centaur XP and ADVIA Centaur XPT Anti-HBe2 (aHBe2) 50T- In vitro diagno... Anti-HBe2 (aHBe2) interference with the Hepatitis B e Antigen (HBeAg) Assay, leads to elevated or... Class II Siemens Healthcare Diagnostics, Inc.
Dec 12, 2022 epoc Host 2 as follows: Product SMN epoc NXS Host, US 11... pO2 High Recovery in Quality Control When Adjusted for Barometric Pressure Class II Siemens Healthcare Diagnostics Inc
Dec 12, 2022 epoc Host 2 as follows: Product SMN epoc Host 10736387 e... pO2 High Recovery in Quality Control When Adjusted for Barometric Pressure Class II Siemens Healthcare Diagnostics Inc
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.

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.