Browse Device Recalls
248 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 248 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 248 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Sep 22, 2025 | DxFLEX Flow Cytometer Catalog Number C78500 UDI-DI code: 15099590754013 T... | Due to a software error code that crashes during acquisition on patient sample when running custo... | Class II | Beckman Coulter Inc. |
| Sep 17, 2025 | SYNCHRON Systems Direct LDL Cholesterol (LDLD) Reagent, REF: 969706 | Beckman Coulter has identified that there is an increased probability Synchron Systems Direct LDL... | Class II | Beckman Coulter Inc. |
| Sep 3, 2025 | SYNCHRON Systems Phosphorus (PHOSm) Reagent REF: 467868 For In Vitro Diagno... | Specific SYNCHRON Systems Modular Chemistry Phosphorus (PHOSm REF 467868) reagent lots may fail c... | Class II | Beckman Coulter Inc. |
| Aug 13, 2025 | UniCel DxH 600 COULTER Cellular Analysis System, configured with the Led HGB ... | Hematology analyzers configured with HGB photometers may result in erroneously high hemoglobin (H... | Class II | Beckman Coulter Inc. |
| Aug 13, 2025 | UniCel DxH 690T COULTER Cellular Analysis System, configured with the Led HGB... | Hematology analyzers configured with HGB photometers may result in erroneously high hemoglobin (H... | Class II | Beckman Coulter Inc. |
| Aug 13, 2025 | UniCel DxH 900 COULTER Cellular Analysis System, configured with the Led HGB ... | Hematology analyzers configured with HGB photometers may result in erroneously high hemoglobin (H... | Class II | Beckman Coulter Inc. |
| Aug 13, 2025 | UniCel DxH 800 COULTER Cellular Analysis System, configured with the Led HGB ... | Hematology analyzers configured with HGB photometers may result in erroneously high hemoglobin (H... | Class II | Beckman Coulter Inc. |
| Aug 4, 2025 | DxC 500 AU Module w/ISE, DxC 500i, With ISE, REF: C63522 and DxC 500 AU Modul... | On a clinical analyzer, when ordering a Clinical Chemistry (CC) combination test simultaneously w... | Class II | Beckman Coulter Inc. |
| Jun 26, 2025 | UIBC (Unsaturated Iron Binding Capacity), REF: OSR61205, | Beckman Coulter identified that the Unsaturated Iron Binding Capacity (UIBC) assay is not meeting... | Class II | Beckman Coulter Inc. |
| Jun 12, 2025 | Estrone RIA, REF: DSL8700. Estrone RIA is an IVD used for the quantitative m... | A specific lot of bovine serum albumin (BSA) used for manufacturing of coated tubes (CT) that are... | Class II | Beckman Coulter Inc. |
| Apr 8, 2025 | REMISOL Advance UDI-DI code: 13700962601874 All Software Versions: B92487;... | Due to a software issue, the software may incorrectly process the date of birth (DoB) received fr... | Class II | Beckman Coulter Inc. |
| Mar 20, 2025 | DxC 500 AU Clinical Chemistry Analyzer, Catalog Numbers/UDI codes: C63519 / ... | Beckman Coulter is recalling their DxC 500 AU Clinical Chemistry Analyzer because a software erro... | Class II | Beckman Coulter Inc. |
| Mar 17, 2025 | DxC 500 AU Clinical Chemistry Analyzer, Catalog Numbers/UDI codes: C63519 / ... | The reason for the recall is incorrect sample barcode identification and processing errors that r... | Class II | Beckman Coulter Inc. |
| Feb 26, 2025 | DxC 500 AU Clinical Chemistry Analyzer, Catalog Numbers/UDI codes: C63519 / ... | Beckman Coulter has determined that device software versions V1.3, V1.4, V1.4.1, V1.4.2, V1.4.3. ... | Class II | Beckman Coulter Inc. |
| Jan 2, 2025 | Access PCT Reagent Pack, Catalog Number C53987, when used on Access 2 and Uni... | Identified reagent lots are experiencing a high rate of calibration failures with failure code of... | Class II | Beckman Coulter Inc. |
| Nov 8, 2024 | Access Intact PTH assay on the DxI 9000 Access Immunoassay Analyzer, Catalog ... | The reason for the recall is that EDTA and lithium heparin plasma samples that are stored in the ... | Class II | Beckman Coulter Inc. |
| Jul 31, 2024 | IMMAGE Immunochemistry Systems IGM Immunoglobulin M Reagent REF 447610 IGM... | Firm identified two lots of reagents that are not meeting the sensitivity statement in the IFU | Class II | Beckman Coulter Inc. |
| May 27, 2024 | Beckman Coulter, REF: OSR61173, IGM 4x14 mL R1, 4x11 mL R2 | LIH Influence check settings for Lipemia are incorrect which may result patient samples being rep... | Class II | Beckman Coulter Inc. |
| Feb 29, 2024 | Beckman Coulter DxI 9000 Access Immunoassay Analyzer is a discrete photometri... | The reason for the recall is the pneumatic tubing used in the analytical pick-and-place (PnP) ass... | Class II | Beckman Coulter, Inc. |
| Jul 12, 2023 | Beckman Coulter, IVD, REF: OSR61171, IgA, 4 x 14 mL R1, 4 x 11 mL R2 | Lipemic interference failed to meet the performance specification listed within the IFU. | Class II | Beckman Coulter Inc. |
| Apr 5, 2023 | Beckman Coulter Bicarbonate, REF: OSR6237, 4x50 mL | There is a potential for a decrease in calibration ODs for Bicarbonate reagent which could result... | Class II | Beckman Coulter Inc. |
| Apr 5, 2023 | Beckman Coulter Bicarbonate, REF: OS6637, 4x173 mL | There is a potential for a decrease in calibration ODs for Bicarbonate reagent which could result... | Class II | Beckman Coulter Inc. |
| Apr 5, 2023 | Beckman Coulter Bicarbonate, REF: OSR6137, 4x25 mL | There is a potential for a decrease in calibration ODs for Bicarbonate reagent which could result... | Class II | Beckman Coulter Inc. |
| Dec 8, 2021 | AU/DxC AU Magnesium, Catalog/REF Number OSR6189, UDI 15099590010850 | Lipemic interference for the Magnesium serum application failed to meet the performance claim as ... | Class II | Beckman Coulter Inc. |
| Nov 10, 2021 | SYNCHRON Systems Cholesterol (CHOL) Reagent, REF: 467825 | Cholesterol Reagent may fail with Out of Calibration Range Low (OCR Low) and/or Back to Back (B/B... | Class II | Beckman Coulter Inc. |
| Aug 9, 2021 | Access hsTnI High Sensitivity Troponin I, REF B52699 Access Immunoassay Sy... | Through customer feedback, testing a sample with cardiac troponin I concentration that are >270,0... | Class II | Beckman Coulter Inc. |
| Aug 5, 2021 | Access SARS CoV-2 IgG (1st IS) Assay: Access Immunoassay Systems REAGENT P... | Firm's submission for Emergency Use Authorization (EUA) contained insufficient evidence to be gra... | Class II | Beckman Coulter Inc. |
| Jul 28, 2021 | Power Processor 3K, 3K High Speed Stockyards Module Nameplate: PP 3K Stockya... | Missing splash guard which may expose users to hazardous materials. . | Class II | Beckman Coulter Inc. |
| Jul 21, 2021 | DxA 5000 (DxA Automation System, DxA 5000 fit), "For in Vitro Diagnostic Use"... | There is a potential that sample carriers (w or w/o samples) within automated sampling system ma... | Class II | Beckman Coulter Inc. |
| Jul 15, 2021 | Normand Remisol Advance Data Manager, REF: C69412, C69413, C44703, and C57017... | There is a potential that the data management system may add additional cells to the patient requ... | Class II | Beckman Coulter Inc. |
| Jul 1, 2021 | Access SARS-CoV-2 Antigen Calibrators, Catalog, REF: C68669, Contents: 1x2.... | SARS-CoV-2 Antigen Assay test may generate false positive results which could result in incorrect... | Class II | Beckman Coulter Inc. |
| Jul 1, 2021 | ACCESS SARS-CoV-2 Antigen , REF: C68668, IVD, Rx only, UDI: (01) 15099590742713; | SARS-CoV-2 Antigen Assay test may generate false positive results which could result in incorrect... | Class II | Beckman Coulter Inc. |
| Jul 1, 2021 | ACCESS SARS-CoV-2 ANTIGEN EXTRACTION SOLUTION, CONTENTS: 6 x 6.0 mL EXTRACTIO... | SARS-CoV-2 Antigen Assay test may generate false positive results which could result in incorrect... | Class II | Beckman Coulter Inc. |
| Jul 1, 2021 | ACCESS SARS-CoV-2 ANTIGEN QC, REF: C68670, CONTENTS: 3 X 6.0 mL QC1, 3 x 6.0 ... | SARS-CoV-2 Antigen Assay test may generate false positive results which could result in incorrect... | Class II | Beckman Coulter Inc. |
| May 7, 2021 | Access SARS-CoV-2 lgG II Calibrator, REF C69058, IVD, CE UDI: (01)15099590742751 | SARS-CoV-2 lgG II numerical results may potentially be multiplied by a factor of 1000 on system... | Class II | Beckman Coulter Inc. |
| May 7, 2021 | Access SARS CoV-2 lgG II Reagent, REF: C69057, IVD CE UDI: (01)15099590742744 | SARS-CoV-2 lgG II numerical results may potentially be multiplied by a factor of 1000 on system... | Class II | Beckman Coulter Inc. |
| Apr 14, 2021 | Access SARS-CoV-2 Antigen, REF C68668, UDI: (01)15099590742713, 3.30 mL/R1a, ... | specimens collected in transport media may result is false negative results when stored in certai... | Class II | Beckman Coulter Inc. |
| Dec 30, 2020 | ACCESS SARS-CoV-2 IgG QC SARS-CoV-2 IgG REF C58964 - Product Usage: use on th... | The Quality Control (QC) card has a label error for the standard deviation (SD) values for one ou... | Class II | Beckman Coulter Inc. |
| Dec 2, 2020 | MicroScan Pos MIC Panel Type 34 - Product Usage: For the determination of ant... | Due to a customer report and internal investigation, it was confirmed that a portion of the affec... | Class II | Beckman Coulter Inc. |
| Aug 26, 2020 | BECKMAN COULTER ACCESS Immunoassay Systems - Access Unconjugated Estriol, REF... | Due to alkaline phosphatase (ALP) associated interference causing falsely elevated uE3 (Unconjuga... | Class II | Beckman Coulter Inc. |
| Aug 18, 2020 | UIBC; Catalog Number: OSR61205; UDI (01) 15099590011925; IVD; Rx Only; WARNIN... | The manufacturer has identified that the use of Unsaturated Iron Binding Capacity (UBIC) lot 2690... | Class II | Beckman Coulter Inc. |
| Mar 30, 2020 | iQ200 Series Urine Microscopy Analyzer- All part numbers | A defect in the SATA power adapter cable within the instrument s computer has the potential risk ... | Class II | Beckman Coulter Inc. |
| Mar 30, 2020 | iChem¿VELOCITY Urine Chemistry System- | A defect in the SATA power adapter cable within the instruments computer has the potential risk f... | Class II | Beckman Coulter Inc. |
| Jan 29, 2020 | ISE Electrolyte Reference (2 X 2L) Reagent, REF A28937, UDI: 15099590202491 -... | Electrolyte reference reagent, used for clinical laboratory testing to determine CO2 in human ser... | Class II | Beckman Coulter Inc. |
| Jan 17, 2020 | LabPro Data Management System, UDI: 15099590676872 - Product Usage: The LabPr... | A security-only update was released via remote diagnostics on January 14, 2020 to customers with ... | Class II | Beckman Coulter Inc. |
| Dec 13, 2019 | Beckman Coulter MicroScan PROMPT Inoculation System-D, Catalog Number B1026-1... | Due to customer reports it has been determined that the inoculation system contains the incorrec... | Class II | Beckman Coulter Inc. |
| Nov 7, 2019 | iChem VELOCITY Urine Chemistry Analyzer | Beckman Coulter has become aware of an issue affecting Specific Gravity chemistry settings for th... | Class II | Beckman Coulter Inc. |
| Oct 28, 2019 | iQ200 Series Urine Microscopy Analyzer, Catalog numbers: 700-3345, 700-3375,... | Customers have reported incidents where two sets of results report the same Specimen Identifier (... | Class II | Beckman Coulter Inc. |
| Oct 28, 2019 | iChemVELOCITY, Urine Chemistry System, Catalog numbers: 700-7176-001, 700-71... | Customers have reported incidents where two sets of results report the same Specimen Identifier (... | Class II | Beckman Coulter Inc. |
| Oct 21, 2019 | MicroScan WalkAway-96 plus Instrument REF B1018-284 | WalkAway Instruments may have been assembled with the incorrect AC power entry connector inlet wi... | Class II | Beckman Coulter 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.