Browse Device Recalls
463 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 463 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 463 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Mar 13, 2024 | Atellica CH Iron3 - IVD use in the quantitative measurement of iron in human ... | Potential for falsely elevated Chol_2, LDLC, and Trig_2 results on the Atellica CH and Atellica C... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Feb 7, 2024 | DCA Systems HbA1c Reagent Kit | The reason for the recall is that the Siemens DCA HbA1c Reagent Kit was confirmed to display a po... | Class II | Siemens Healthcare Diagnostics, Inc. |
| 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. |
| 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. |
| 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 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 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. |
| 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. |
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.