Browse Device Recalls
571 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 571 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 571 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jan 20, 2026 | Atellica CH Urine Albumin (UAlb). Material Number: 11537225 | Falsely depressed UAlb patient results may occur. Affected samples with any urine albumin concen... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Oct 6, 2025 | IMMULITE 2000 Oak Mix Specific Allergen; Siemens Material Number (SMN): 1038... | The barcode orientation on affected devices causes incorrect scanning order of tubes within the a... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Oct 6, 2025 | 3gAllergy Specific IgE Universal Kit; Kit Component: 3gAllergy Specific IgE ... | The barcode orientation on affected devices causes incorrect scanning order of tubes within the a... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Oct 6, 2025 | Food Panel 3 Specific Allergen; Siemens Material Number (SMN): 10385891; Ca... | The barcode orientation on affected devices causes incorrect scanning order of tubes within the a... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Sep 22, 2025 | Assay: IMMULITE 2000 Intact PTH; Test Code: iPT; Siemens Material Number (S... | The potential for falsely depressed Intact PTH patient results at the low end of the assay range,... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Aug 11, 2025 | Atellica CH Urinary/Cerebrospinal Fluid Protein (UCFP). Material Number: 1109... | Potential for falsely depressed patient, quality control (QC), and/or calibration results or dela... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Jun 4, 2025 | ADVIA¿ 120/2120/2120i SETpoint Calibrator | Products have the incorrect platelet (PLT) value assignments for the ADVIA 120/2120/2120i Hematol... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Jun 4, 2025 | ADVIA¿ 120/2120/2120i 3-in-1 TESTpoint Control (ABN1 Control) | Products have the incorrect platelet (PLT) value assignments for the ADVIA 120/2120/2120i Hematol... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Jun 4, 2025 | ADVIA¿ 120/2120/2120i 3-in-1 TESTpoint Control (Norm Control) | Products have the incorrect platelet (PLT) value assignments for the ADVIA 120/2120/2120i Hematol... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Jun 4, 2025 | ADVIA¿ 120/2120/2120i 3-in-1 TESTpoint Control (ABN2 Control) | Products have the incorrect platelet (PLT) value assignments for the ADVIA 120/2120/2120i Hematol... | Class II | Siemens Healthcare Diagnostics, Inc. |
| May 22, 2025 | Product: Atellica CH Diluent - CONS 2 x 1.5L; Siemens Material Number (SMN):... | Contamination of the diluent by sodium hypochlorite (NaOCl) which may impact calibrator, quality ... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Apr 15, 2025 | ADVIA Centaur HCY Calibrator (2 Pack). Siemens Material Number: 10310376. | Certain lots of Atellica IM Homocysteine Calibrator and ADVIA Centaur HCY Calibrator do not meet ... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Apr 15, 2025 | Atellica IM Homocysteine Calibrator (2 Pack). Siemens Material Number: 10995498 | Certain lots of Atellica IM Homocysteine Calibrator and ADVIA Centaur HCY Calibrator do not meet ... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Mar 11, 2025 | Atellica CH Revised C Reactive Protein (RCRP); Siemens Material Number (SMN):... | Incorrect software flagging may occur for the assay that may potentially lead to an erroneous res... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Nov 22, 2024 | epoc NXS Host; Siemens Material Number (SMN): 11413583(CN, KR) ; Software Ver... | Siemens Healthcare Diagnostics is recalling their epoc Blood Analysis System because of a softwar... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Nov 22, 2024 | epoc NXS Host; Siemens Material Number (SMN): 11413497 (EU); Software Version... | Siemens Healthcare Diagnostics is recalling their epoc Blood Analysis System because of a softwar... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Nov 22, 2024 | epoc NXS Host; Siemens Material Number (SMN): 11413517(MX) ; Software Version... | Siemens Healthcare Diagnostics is recalling their epoc Blood Analysis System because of a softwar... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Nov 22, 2024 | epoc NXS Host; Siemens Material Number (SMN): 11413506 (CA); Software Version... | Siemens Healthcare Diagnostics is recalling their epoc Blood Analysis System because of a softwar... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Nov 22, 2024 | epoc NXS Host; Siemens Material Number (SMN): 11413475 (US); Software Version... | Siemens Healthcare Diagnostics is recalling their epoc Blood Analysis System because of a softwar... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Nov 22, 2024 | epoc NXS Host; Siemens Material Number (SMN): 11413518 (ROW) ; Software Versi... | Siemens Healthcare Diagnostics is recalling their epoc Blood Analysis System because of a softwar... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Nov 22, 2024 | epoc NXS Host; Siemens Material Number (SMN): 11413879(IN) ; Software Version... | Siemens Healthcare Diagnostics is recalling their epoc Blood Analysis System because of a softwar... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Nov 22, 2024 | epoc NXS Host; Siemens Material Number (SMN): 11413498(JP) ; Software Version... | Siemens Healthcare Diagnostics is recalling their epoc Blood Analysis System because of a softwar... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Nov 12, 2024 | Magnesium Flex reagent cartridge, 360 tests, Catalog Number: K3057; Siemens M... | Siemens Healthcare Diagnostics is recalling two lots of their Dimension Vista¿ Total Magnesium (M... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Nov 4, 2024 | Atellica CI Analyzer. Catalog Numbers: 10947347. | Potential that the IMT Diluent volume remaining (% remaining) does not decrease as expected on th... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Oct 21, 2024 | Siemens Atellica CH Reaction Ring Cuvette Segment-has cuvettes that contain a... | A manufacturing defect causes Atellica CH Reaction Ring Cuvette Segments with lot numbers N15 o... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Oct 21, 2024 | Atellica¿ CH ¿2-Microglobulin (B2M) - In vitro diagnostic use in the quantita... | Potential for falsely depressed auto-diluted results for samples above the measuring interval of... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Sep 30, 2024 | IMMULITE 2000 PSA assay, Catalog Number L2KPTS2(D) (SMN 10706281) and Catalog... | The IMMULITE 2000 PSA assay for use on the IMMULITE 2000 and IMMULITE 2000 XPi analyzers did not ... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Aug 21, 2024 | ADVIA Centaur aTPO Assay, Material Number 10630886 (100 Test) and 10630887 (5... | Positive bias in patient results at and below the cut-off of 60 U/mL with the lots listed in the ... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Aug 21, 2024 | Atellica IM aTPO Assay, Material Number 10995466 (100 Test) and 10995467 (500... | Positive bias in patient results at and below the cut-off of 60 U/mL with the lots listed in the ... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Aug 15, 2024 | ADVIA Chemistry Microalbumin_2 (¿ALB_2) -For in vitro diagnostic use in the q... | Atellica CH Microalbumin_2 (¿ALB_2) and the ADVIA Chemistry Microalbumin_2 (¿ALB_2) are not meeti... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Aug 15, 2024 | Atellica CH Microalbumin_2 (¿ALB_2)-For in vitro diagnostic use in the quanti... | Atellica CH Microalbumin_2 (¿ALB_2) and the ADVIA Chemistry Microalbumin_2 (¿ALB_2) are not meeti... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Jul 30, 2024 | Dimension Vista¿ Total Bilirubin (TBIL) Flex Reagent Cartridge; Siemens Mater... | During manufacturing, the last three tests from the 160 test flex of lot 23206BA (wells 8 or 10) ... | Class II | Siemens Healthcare Diagnostics, Inc. |
| 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. |
| 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. |
| 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. |
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.