Browse Device Recalls
89 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 89 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 89 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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. |
| Dec 19, 2023 | Beckman Coulter DxU 850m/840m Microscopy Analyzers, Part Numbers: C49513, C7... | Beckman Coulter has become aware that the cannula, which is found in the Flowcell and the iQClear... | Class II | Beckman Coulter, Inc. |
| Nov 21, 2023 | DxI 9000 Access Immunoassay Analyzer running software version 1.16 or prior, | There are potential performance issues found in the DxI 9000 Access Immunoassay Analyzer, includi... | Class II | Beckman Coulter, Inc. |
| Nov 21, 2023 | Access Ultrasensitive Insulin only used on the DxI 9000 Access Immunoassay An... | There is an issue with the Access Ultrasensitive Insulin assay protocol file (APF) for use with t... | Class II | Beckman Coulter, Inc. |
| Sep 12, 2023 | DxI 9000 Access Immunoassay Analyzer, REF C11137, Sofware Versions 1.15 and b... | The firm has investigated and confirmed that when DxI 9000 is connected to Laboratory Information... | Class II | Beckman Coulter, Inc. |
| Jul 6, 2023 | Access Thyroglobulin Calibrators | It has been determined through an internal investigation that the alternate Access Thyroglobulin ... | Class II | Beckman Coulter, Inc. |
| Jun 20, 2023 | Ringed DxI Reaction Vessels (RVs) | Beckman Coulter, Inc. is recalling Ringed DxI Reaction Vessels (RVs) as part of Unicel DxI Immuno... | Class II | Beckman Coulter, Inc. |
| May 31, 2023 | COULTER DxH Diluent, REF 628017; diluent used for counting and sizing blood c... | Specific diluent lot numbers showed that conductivity, osmolality, and pH were out of manufacturi... | Class II | Beckman Coulter, Inc. |
| May 17, 2023 | Access Hybritech p2PSA reagent, REF B03704 and REF A49752. | Reagent lot numbers include an insufficient concentration of blocking reagent. | Class II | Beckman Coulter, Inc. |
| Apr 5, 2023 | DxU 850m Iris Urine Microscopy Analyzer Catalog Number C49513, in-vitro diagn... | Beckman Coulter has become aware of an intermittent issue in which the optional flag "Previous Sa... | Class II | Beckman Coulter, Inc. |
| Apr 5, 2023 | UA WIN 10 Kit, Catalog Number C52900, in-vitro diagnostic device, urine analysis | Beckman Coulter has become aware of an intermittent issue in which the optional flag "Previous Sa... | Class II | Beckman Coulter, Inc. |
| Apr 5, 2023 | iQ200 Series Urine Microscopy Analyzer: a) iQ 200 Select, Part Numbers C1068... | Beckman Coulter has become aware of an intermittent issue in which the optional flag Previous Sa... | Class II | Beckman Coulter, Inc. |
| Apr 5, 2023 | DxU 840m Iris Urine Microscopy Analyzer, Catalog Number C76947, in-vitro diag... | Beckman Coulter has become aware of an intermittent issue in which the optional flag "Previous Sa... | Class II | Beckman Coulter, Inc. |
| Mar 15, 2023 | Beckman Coulter Access Free T3, Triiodothyronine, Free, Catalog #A13422, each... | The reagent lot produces elevated results (approximately >30%) in some (15-20%)patient samples th... | Class II | Beckman Coulter, Inc. |
| Jan 26, 2023 | Access Immunoassay Systems (1) Access 2 Immunoassay Analyzer (81600N); (2... | An increased incidence of damage to the nut band from a new vendor (Boamax) has led to an increas... | Class II | Beckman Coulter, Inc. |
| Nov 18, 2022 | BECKMAN COULTER IRISpec CA/CB/CC control, REF 900-7211, For in vitro diagnost... | Beckman Coulter has become aware of an increase in customer complaints generated for intermittent... | Class II | Beckman Coulter, Inc. |
| Oct 3, 2022 | MicroScan autoSCAN-4 Instrument, Catalog Number B1018-280 | Due to MicroScan autoSCAN-4 Instruments being manufactured with an incorrect diffuser plate. | Class II | Beckman Coulter, Inc. |
| May 25, 2022 | BECKMAN COULTER, INC. a. COULTER DxH Diff Pack REAGENT, DIFF PK FP DXHCOULT... | Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to highe... | Class II | Mckesson Medical-Surgical Inc. Corporate Office |
| Feb 16, 2022 | Beckman Coulter IRISpec CA/CB/CC control, Catalog #800-7211, containing 3 x 1... | IRISpec CA failures for glucose. | Class III | Beckman Coulter, Inc. |
| Jun 23, 2021 | Kaluza C Flow Cytometry Software Versions: 1.0*, 1.1.1 and 1.1.2 Kits: C10... | Software anomalies that may lead to the generation of erroneous results. | Class II | Beckman Coulter, Inc. |
| Feb 17, 2020 | iChemVELOCITY Strips, Catalog 800-7212 | The Leukocyte and Compensation pads were switched on some vials of lot number 7212269M of the iCh... | Class II | Beckman Coulter, Inc. |
| Oct 7, 2019 | UniCel DxH Slidemaker Stainer (DxH SMS) and UniCel DxH Slidemaker Stainer II ... | When the UniCel DxH Slidemaker Stainer and UniCel DxH Slidemaker Stainer II dispense probe is sli... | Class II | Beckman Coulter, Inc. |
| Sep 17, 2018 | Kaluza C Flow Cytometry Software, RX Only in the U.S.A., Beckman Coulter, Inc... | Compatibility issue between the software and Microsoft updates to Windows 7, 8, and 10. The comp... | Class II | Beckman Coulter Inc. |
| May 24, 2018 | Sorting-Drive Professional Part, Sorting-Drive Professional Kit, (Sorting Dr... | Sorting-Drive software version 4.2 (released in October 2015) introduced a new option for iPAW an... | Class III | Beckman Coulter Inc. |
| May 24, 2018 | Intelligent Peri-Analytical Workstation (HW+SW), Catalog #: A89492 (iPAW Soft... | Sorting-Drive software version 4.2 (released in October 2015) introduced a new option for iPAW an... | Class III | Beckman Coulter Inc. |
| May 24, 2018 | Sorting-Drive Product Part, Sorting-Drive Plus Kit (Sorting Drive Software v4... | Sorting-Drive software version 4.2 (released in October 2015) introduced a new option for iPAW an... | Class III | Beckman Coulter Inc. |
| Aug 31, 2015 | Access Free T3 Reagent Kit, P/N A13422 The Access Free T3 assay is a param... | Beckman Coulter, Inc. is recalling Access Free T3 Reagent Kit because they were filled incorrectl... | Class II | Beckman Coulter Inc. |
| Jul 28, 2015 | Access Thyroglobulin Assay; 100 determinations, 2 packs, 50 tests/pack. For t... | Beckman Coulter, Inc. is recalling Access Thyroglobulin reagent packs because some may exhibit gr... | Class II | Beckman Coulter Inc. |
| Aug 8, 2014 | MicroScan Microbiology Systems: Dried Gram Negative MIC/Combo Panels Contain... | Technical Support Bulletin issued in February 2013 did not mention performance limitation for Pro... | Class II | Beckman Coulter, Inc. |
| Aug 8, 2014 | MicroScan Microbiology Systems: Dried Gram Negative MIC/Combo Panels Contain... | Technical Support Bulletin issued in February 2013 did not mention performance limitation for Pro... | Class II | Beckman Coulter, Inc. |
| Aug 8, 2014 | MicroScan Microbiology Systems: Dried Gram Negative MIC/Combo Panels Contain... | Technical Support Bulletin issued in February 2013 did not mention performance limitation for Pro... | Class II | Beckman Coulter, Inc. |
| Aug 8, 2014 | MicroScan Microbiology Systems: Dried Gram Negative MIC/Combo Panels Contain... | Technical Support Bulletin issued in February 2013 did not mention performance limitation for Pro... | Class II | Beckman Coulter, Inc. |
| Aug 8, 2014 | MicroScan Microbiology Systems: Dried Gram Negative MIC/Combo Panels Contain... | Technical Support Bulletin issued in February 2013 did not mention performance limitation for Pro... | Class II | Beckman Coulter, Inc. |
| Aug 8, 2014 | MicroScan Microbiology Systems: Dried Gram Negative MIC/Combo Panels Contain... | Technical Support Bulletin issued in February 2013 did not mention performance limitation for Pro... | Class II | Beckman Coulter, Inc. |
| Aug 8, 2014 | MicroScan Microbiology Systems: Dried Gram Negative MIC/Combo Panels Contain... | Technical Support Bulletin issued in February 2013 did not mention performance limitation for Pro... | Class II | Beckman Coulter, Inc. |
| May 14, 2014 | MicroScan -Neg Breakpoint Combo Panel Type 34; Catalog number B1017-404; Pan... | Siemens Healthcare Diagnostics has received complaints regarding panel degradation with a portion... | Class II | Beckman Coulter, Inc. |
| Apr 8, 2014 | MicroScan Pos Combo Panel Type 33 (PC33): Catalog number B1017-211 Micro... | Siemens investigation confirmed that a portion one lot of panel Pos Combo 33 lot was packaged wi... | Class II | Beckman Coulter, Inc. |
| Jul 16, 2013 | Hemoccult II BRAND SENSA elite; MATERIALS AND REAGENTS; Hemoccult II SENSA el... | The products may have been stored at temperatures outside their required storage conditions. | Class II | Assuramed |
| Mar 20, 2013 | AU5800 Clinical Chemistry Analyzer The Beckman Coulter AU5800 Clinical Che... | Beckman Coulter, Inc. initiated this recall because there is a software error that has the potent... | 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.