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.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jul 29, 2024 | ADVIA Chemistry Urinary/Cerebrospinal Fluid Protein (UCFP); Siemens Material ... | The potential for biased quality control (QC) and patient results when using Atellica CH UCFP lo... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Jul 29, 2024 | Atellica CH Urinary/Cerebrospinal Fluid Protein (UCFP); Siemens Material Numb... | The potential for biased quality control (QC) and patient results when using Atellica CH UCFP lo... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Jul 26, 2024 | Atellica IM CA 19-9 (250 Test)- In vitro diagnostic use in the quantitative m... | Positive bias for some samples around the CA 19-9 upper limit of normal of 35 U/m as compared to ... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Jul 26, 2024 | ADVIA Centaur CA 19-9 (250 Test)-In vitro diagnostic use in the quantitative ... | Positive bias for some samples around the CA 19-9 upper limit of normal of 35 U/m as compared to ... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Jul 26, 2024 | Atellica IM CA 19-9 (250 Test - REF)-In vitro diagnostic use in the quantitat... | Positive bias for some samples around the CA 19-9 upper limit of normal of 35 U/m as compared to ... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Jul 26, 2024 | ADVIA Centaur CA 19-9 (50 Test)-In vitro diagnostic use in the quantitative m... | Positive bias for some samples around the CA 19-9 upper limit of normal of 35 U/m as compared to ... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Jul 26, 2024 | Atellica IM CA 19-9 (50 Test)-In vitro diagnostic use in the quantitative mea... | Positive bias for some samples around the CA 19-9 upper limit of normal of 35 U/m as compared to ... | Class II | Siemens Healthcare Diagnostics, Inc. |
| May 17, 2024 | Software version 5.3 in: RAPIDPoint 500e Blood Gas System (USA) Siemens Ma... | Siemens Healthineers has identified an issue with the RAPIDPoint500e system software version 5.3.... | Class II | Siemens Healthcare Diagnostics Inc |
| Apr 23, 2024 | IMMULITE 2000 Anti-TG Ab Catalog # L2KTG6 (600 Tests), SMN 10381655, System... | The potential for falsely elevated patient sample results when using impacted lots (785, 790, 791... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Apr 23, 2024 | IMMULITE 2000 Anti-TG Ab Catalog # L2KTG2 (200 Tests), SMN 10381659, System... | The potential for falsely elevated patient sample results when using impacted lots (782, 783, 785... | Class II | Siemens Healthcare Diagnostics, Inc. |
| 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. |
| 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 |
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.