Browse Device Recalls
88 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 88 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 88 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Dec 23, 2025 | CellMek SPS Sample Preparation System, REF: C44603, with software | Sample preparation system designed to automate staining, lysing, cell washing has a software erro... | Class II | Beckman Coulter, Inc. |
| Nov 26, 2025 | Beckman Coulter UniCel Dxl 800, Part numbers: 973100, A71456, A71457, A25288... | Beckman Coulter has determined that, due to a potential communication issue, the analyzers listed... | Class II | Beckman Coulter, Inc. |
| Nov 26, 2025 | Beckman Coulter UniCel Dxl 600, Part numbers: A71460, A71461, A30260; Immun... | Beckman Coulter has determined that, due to a potential communication issue, the analyzers listed... | Class II | Beckman Coulter, Inc. |
| Nov 10, 2025 | COULTER DxH Diluent, REF 628017 COULTER DxH ECO Diluent REF C67250 For us... | Due to specific lots of diluents contributing to elevated platelet Daily Checks background counts... | Class II | Beckman Coulter, Inc. |
| Nov 7, 2025 | Access 2 Reaction Vessels, individual, disposable, plastic tubes used to proc... | It has been determined that certain lots of Access 2 Reaction Vessels may contain manufacturing d... | Class II | Beckman Coulter, Inc. |
| Oct 1, 2025 | Beckman Coulter UniCel DxI 800, Part Numbers: 973100, A71456; Photometric Ch... | An internal investigation has determined that due to defective sub-components within the gantry a... | Class II | Beckman Coulter, Inc. |
| Oct 1, 2025 | Beckman Coulter UniCel DxI 600, Part Numbers: A71460, A30260; Photometric Ch... | An internal investigation has determined that due to defective sub-components within the gantry a... | Class II | Beckman Coulter, Inc. |
| Sep 19, 2025 | DxC 500i Clinical Analyzer Modules, DxC 500 AU Module w/ISE, DxC 500i (Part N... | Beckman Coulter has confirmed a software anomaly on DxI 9000 Access Immunoassay Analyzer and the ... | Class II | Beckman Coulter, Inc. |
| Sep 19, 2025 | DxI 9000 Access Immunoassay Analyzer, Part Number C11137 | Beckman Coulter has confirmed a software anomaly on DxI 9000 Access Immunoassay Analyzer and the ... | Class II | Beckman Coulter, Inc. |
| Sep 8, 2025 | CellMek SPS Sample Preparation System, REF: C44603. Software versions 2.2.122... | Automated pipetting, diluting and specimen processing workstations for flow cytometric analysis d... | Class II | Beckman Coulter, Inc. |
| Jul 10, 2025 | Access Thyroglobulin assay, a simultaneous one-step immunoenzymatic assay, Ca... | Access Thyroglobulin reagent lot 439163 may generate erroneously high patient results. Falsely in... | Class II | Beckman Coulter, Inc. |
| Jun 25, 2025 | UniCel DxI 800 Access Immunoassay Analyzer, Part Number 973100 | Beckman Coulter has identified that the UniCel DxI 600/800 systems with linear slide PnP gantries... | Class II | Beckman Coulter, Inc. |
| Jun 25, 2025 | UniCel DxI 600 Access Immunoassay Analyzer, Part Number A30260 | Beckman Coulter has identified that the UniCel DxI 600/800 systems with linear slide PnP gantries... | Class II | Beckman Coulter, Inc. |
| Jun 25, 2025 | DxI 600 Access Immunoassay Analyzer W/Dual Gantry, Part Number A71461 | Beckman Coulter has identified that the UniCel DxI 600/800 systems with linear slide PnP gantries... | Class II | Beckman Coulter, Inc. |
| Jun 25, 2025 | DxI 800 Access Immunoassay Analyzer W/Spot B, Part Number A71456 | Beckman Coulter has identified that the UniCel DxI 600/800 systems with linear slide PnP gantries... | Class II | Beckman Coulter, Inc. |
| Jun 25, 2025 | DxI 600 Access Immunoassay Analyzer W/Spot B, Part Number A71460 | Beckman Coulter has identified that the UniCel DxI 600/800 systems with linear slide PnP gantries... | Class II | Beckman Coulter, Inc. |
| Jun 25, 2025 | DxI 800 Access Immunoassay Analyzer W/Dual Gantry, Part Number A71457 | Beckman Coulter has identified that the UniCel DxI 600/800 systems with linear slide PnP gantries... | Class II | Beckman Coulter, Inc. |
| May 7, 2025 | DxI 9000 Access Immunoassay Analyzer C11137 | Analyzer has calibration issues where curves switched from passed to failed due to system errors ... | Class II | Beckman Coulter, Inc. |
| May 5, 2025 | Access Testosterone assay, Catalog Number 33560 | Inadequate preventative maintenance (PM) performed on the scales of the RPL5 fill line, led to s... | Class II | Beckman Coulter, Inc. |
| Apr 23, 2025 | DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137, running software... | A new motor/encoder and cable was introduced into instruments manufactured starting with serial n... | Class II | Beckman Coulter, Inc. |
| Apr 23, 2025 | DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137, running software... | A new software update (v1.20) is introducing error codes for the Dxl 9000 which prevents the assa... | Class II | Beckman Coulter, Inc. |
| Mar 27, 2025 | Beckman Coulter DxI 9000 Access Immunoassay Analyzer | When DxI 9000 Access Immunoassay Analyzer is connected to a host system (laboratory information s... | Class II | Beckman Coulter, Inc. |
| Feb 27, 2025 | Access Vitamin B12 Reagent, Catalog Number 33000, Lot Number 439850 | Beckman Coulter has received complaints of erroneous Vitamin B12 results when using Access Vitami... | Class II | Beckman Coulter, Inc. |
| Feb 6, 2025 | DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137, with Component P... | Beckman Coulter identified that an issue for DxI 9000 tip stocker interface (TSI) and reagent sto... | Class II | Beckman Coulter, Inc. |
| Feb 5, 2025 | DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137. | the DxI 9000 encoder wheel was misaligned on the motor shaft, leading to increased slippage error... | Class II | Beckman Coulter, Inc. |
| Feb 5, 2025 | Access 2 Immunoassay Analyzer, Catalog Number 81600N | Beckman Coulter identified that an issue for Access 2 Sample Motors (B48016) due to improper alig... | Class II | Beckman Coulter, Inc. |
| Feb 3, 2025 | Access Erythropoietin (EPO), Catalog Number - A16364 a glycoprotein (~30,400... | Affected lot (439363) exhibited a negative dose drop of -22% with native patient samples compared... | Class II | Beckman Coulter, Inc. |
| Nov 26, 2024 | Access Intact PTH assay, a paramagnetic particle, chemiluminescent immunoassa... | Beckman Coulter has identified that some Access PTH reagent packs from lot 339071 may be over- or... | Class II | Beckman Coulter, Inc. |
| Nov 18, 2024 | Access hsTnI Reagent, REF B52699, Immunoassay Method, Troponin Subunit. For ... | Beckman Coulter, Inc. is recalling their Access hsTnI assay, a medical device by correction. The ... | Class II | Beckman Coulter, Inc. |
| Nov 13, 2024 | DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137 | The DxI 9000 Access Immunoassay Analyzer wash wheel mixer may not spin freely within the idler p... | Class II | Beckman Coulter, Inc. |
| Sep 30, 2024 | The Access Cortisol assay is a paramagnetic particle, chemiluminescent immun... | The Access Cortisol assay protocol file (APF) applies an incorrect calibration curve acceptance p... | Class II | Beckman Coulter, Inc. |
| Sep 5, 2024 | Access Thyroglobulin Antibody II, REF A32898, containing Instructions for Use... | IFUs for the device incorrectly states the biotin interference was remediated. The issue could r... | Class II | Beckman Coulter, Inc. |
| Aug 28, 2024 | The Access TSH (3rd IS) assay is a paramagnetic particle, chemiluminescent im... | Certain lots of Access TSH reagent packs may produce erroneously low TSH (thyroid-stimulating hor... | Class II | Beckman Coulter, Inc. |
| Jul 16, 2024 | Beckman Coulter IRISPEC CA/CB/CC Urine Chemistry Controls, Catalog Number REF... | Beckman Coulter has become aware of an increase in customer complaints for intermittent IRISpec C... | Class III | Beckman Coulter, Inc. |
| Jul 12, 2024 | DxI 9000 Access Immunoassay Analyzer, catalog number C11137 in vitro diagn... | Ground screws on Dxl 9000 PCB boards may cause electric shorts, leading to smoke and potentially ... | Class II | Beckman Coulter, Inc. |
| Jul 10, 2024 | Beckman Coulter DxI 9000 Access Immunoassay Analyzer, Model Number C21510, RS... | Beckman Coulter is recalling the DxI 9000 Access Immunoassay Analyzer due to undersized Pneumatic... | Class II | Beckman Coulter, Inc. |
| Jun 14, 2024 | Discrete photometric chemistry analyzer for clinical use. | Beckman Coulter, Inc. has identified a rise in reagent carousel motion errors in Access 2 Immunoa... | Class II | Beckman Coulter, Inc. |
| Jun 4, 2024 | Dxl 9000 Access Immunoassay Analyzer, Catalog #C11137. | The analyzers were built with nonconforming USB cables made with brass contacts instead of specif... | Class II | Beckman Coulter, Inc. |
| May 22, 2024 | Beckman Coulter DxI 9000 Access Immunoassay Analyzer, Catalog #C11137. | The reason for this recall is Beckman Coulter has determined that when a DxI 9000 Access Immunoas... | Class II | Beckman Coulter, Inc. |
| May 22, 2024 | DxI 9000 Access Immunoassay Analyzer, Catalog #C11137. | When a DxI 9000 Access Immunoassay Analyzer is connected to a Laboratory Automation System (LAS) ... | Class II | Beckman Coulter, Inc. |
| Apr 18, 2024 | Beckman Coulter Dxl 9000 Access Immunoassay Analyzer, REF #C11137. An in vitr... | When the DxI 9000 Access Immunoassay Analyzer with system software version 1.16.2 and prior is co... | Class II | Beckman Coulter, Inc. |
| Apr 18, 2024 | DxI 9000 Access Immunoassay Analyzer, C11137; in-vitro diagnostic | Beckman Coulter is recalling their DxI 9000 Access Immunoassay Analyzers, an in vitro diagnostic ... | Class II | Beckman Coulter, Inc. |
| Mar 5, 2024 | DxI 9000 Access Immunoassay Analyzer, REF C11137, vitro diagnostic device use... | Beckman Coulter manufacturing discovered cracks around a threaded insert on the bottom of the Int... | 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. |
| Feb 8, 2024 | Access Total T4, REF 33800, IVD, thyroxine reagent assay. | Four lots of Access Total T4 reagent lots demonstrated imprecision outside of the 10% specificati... | Class II | Beckman Coulter, Inc. |
| Feb 7, 2024 | Access Substrate, REF 81906, For use with the Access Immunoassay Systems | On 07 February 2024 Beckman Coulter made the decision to conduct a field action on Access Substra... | Class II | Beckman Coulter, Inc. |
| Jan 3, 2024 | Beckman Coulter DxI 9000 Access Immunoassay Analyzer, catalog number C11137; ... | A software error caused an increase in tray gripper motion errors that causes intermittent hard s... | Class II | Beckman Coulter, Inc. |
| Dec 19, 2023 | REV 2 Flowcell Capsule Spare, Part Number: C04154 | Beckman Coulter has become aware that the cannula, which is found in the Flowcell and the iQClear... | Class II | Beckman Coulter, Inc. |
| Dec 19, 2023 | iQ Waste Well Adapter, Part Number: 700-3393 | Beckman Coulter has become aware that the cannula, which is found in the Flowcell and the iQClear... | Class II | Beckman Coulter, Inc. |
| Dec 19, 2023 | iQ200 Series Urine Microscopy Analyzers, Part Numbers: a) 700-3320, b) 7... | Beckman Coulter has become aware that the cannula, which is found in the Flowcell and the iQClear... | 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.