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 |
|---|---|---|---|---|
| Oct 21, 2019 | MicroScan WalkAway-96 plus Reconditioned Instrument REF B1018-396R | WalkAway Instruments may have been assembled with the incorrect AC power entry connector inlet wi... | Class II | Beckman Coulter Inc. |
| Oct 21, 2019 | MicroScan WalkAway-40 plus Reconditioned Instrument REF B1018-340R | WalkAway Instruments may have been assembled with the incorrect AC power entry connector inlet wi... | Class II | Beckman Coulter Inc. |
| Oct 21, 2019 | DxM 1040 MicroScan WalkAway Instrument REF B1018-440 | WalkAway Instruments may have been assembled with the incorrect AC power entry connector inlet wi... | Class II | Beckman Coulter Inc. |
| Oct 21, 2019 | DxM 1096 MicroScan WalkAway Instrument REF B1018-496 | WalkAway Instruments may have been assembled with the incorrect AC power entry connector inlet wi... | Class II | Beckman Coulter Inc. |
| Oct 21, 2019 | MicroScan WalkAway-40 plus Instrument REF B1018-283 | WalkAway Instruments may have been assembled with the incorrect AC power entry connector inlet wi... | Class II | Beckman Coulter Inc. |
| Sep 4, 2019 | Opiate 300 Ng Reagent (OP 1 X 250) for use in conjunction with UniCel DxC 600... | Cross-reactivity testing may not meet the claims indicated in the Opiate 300 ng (OP)Instructions ... | Class II | Beckman Coulter Inc. |
| Sep 4, 2019 | MicroScan WalkAway-96 plus Instrument | Instruments were manufactured with a shortened 30mL reagent draw straw which may result in reagen... | Class II | Beckman Coulter Inc. |
| Sep 4, 2019 | MicroScan WalkAway-96 plus Reconditioned Instrument | Instruments were manufactured with a shortened 30mL reagent draw straw which may result in reagen... | Class II | Beckman Coulter Inc. |
| Sep 4, 2019 | Synchron Systems Opiate 2000 ng Reagent (OP2 1 x 250); catalogue no. 475006 f... | Cross-reactivity testing may not meet the claims indicated in the Opiate 2000 ng (OP2) Instructio... | Class II | Beckman Coulter Inc. |
| Sep 4, 2019 | MicroScan WalkAway-40 plus Reconditioned Instrument | Instruments were manufactured with a shortened 30mL reagent draw straw which may result in reagen... | Class II | Beckman Coulter Inc. |
| Sep 4, 2019 | MicroScan WalkAway-40 plus Instrument | Instruments were manufactured with a shortened 30mL reagent draw straw which may result in reagen... | Class II | Beckman Coulter Inc. |
| Aug 15, 2019 | Direct Bilirubin Reagents (DBIL 2 x 200 ) and (DBIL 2 x 300), Ref:439715 (200... | It has been determined that N-acetyl p benzoquinone imine (NAPQI), a metabolite of acetaminophen ... | Class II | Beckman Coulter Inc |
| Aug 15, 2019 | Total Bilirubin Reagent (TBIL 2 x 300 ) and (TBIL 2 x 400), Ref:442745 (300 t... | It has been determined that N-acetyl p benzoquinone imine (NAPQI), a metabolite of acetaminophen ... | Class II | Beckman Coulter Inc |
| Aug 15, 2019 | Uric Acid Reagent (URIC 2 X 300), REF: 442785, For In Vitro Diagnostic Use, R... | It has been determined that N-acetyl p benzoquinone imine (NAPQI), a metabolite of acetaminophen ... | Class II | Beckman Coulter Inc |
| Aug 15, 2019 | Enzymatic Creatinine Reagent (CR-E 2 X 200), REF A60298, For in Vitro Diagnos... | It has been determined that N-acetyl p benzoquinone imine (NAPQI), a metabolite of acetaminophen ... | Class II | Beckman Coulter Inc |
| Aug 15, 2019 | Triglycerides Reagent (TG 2 x 300), REF: 445850, For In Vitro Diagnostic Use,... | It has been determined that N-acetyl p benzoquinone imine (NAPQI), a metabolite of acetaminophen ... | Class II | Beckman Coulter Inc |
| Jun 12, 2019 | SYNCHRON Systems Barbiturates Reagent (BARB 1 X 250); Catalog No. 475012 - Pr... | The firm has identified that cross-reactivity testing may not meet the claims indicated in the Ba... | Class II | Beckman Coulter Inc. |
| May 17, 2019 | Beckman Coulter Power Express Sample Processing System AU5800XL connection un... | Potential exposure to biohazard. Software design problem causes excess speed and vibrations in... | Class II | Beckman Coulter Inc. |
| Apr 30, 2019 | Beckman Coulter Access Immunoassay Systems, Access Free T4 Thyroxine, REF 338... | The recalling firm characterized the potential interference effects of biotin (up to 1,200 ng/mL)... | Class II | Beckman Coulter Inc. |
| Apr 30, 2019 | Beckman Coulter ACCESS Immunoassay Systems, Access Thyroglobulin Antibody II,... | The recalling firm characterized the potential interference effects of biotin (up to 1,200 ng/mL... | Class II | Beckman Coulter Inc. |
| Apr 30, 2019 | Beckman Coulter Access Immunoassay Systems, Access Free T3 Triiodothyronine, ... | The recalling firm characterized the potential interference effects of biotin (up to 1,200 ng/mL... | Class II | Beckman Coulter Inc. |
| Apr 30, 2019 | Beckman Coulter ACCESS Immunoassay Systems, Access Thyroglobulin, REF 33860 (... | The recalling firm characterized the potential interference effects of biotin (up to 1,200 ng/mL... | Class II | Beckman Coulter Inc. |
| Apr 30, 2019 | Beckman Coulter ACCESS Immunoassay Systems, Access GI Monitor Cancer Antigen ... | The recalling firm characterized the potential interference effects of biotin (up to 1,200 ng/mL... | Class II | Beckman Coulter Inc. |
| Apr 30, 2019 | Beckman Coulter ACCESS Immunoassay Systems, Access Total T3 Triiodothyronine ... | The recalling firm characterized the potential interference effects of biotin (up to 1,200 ng/mL)... | Class II | Beckman Coulter Inc. |
| Dec 5, 2018 | The UniCel DxI 600 and 800 Access Immunoassay Systems, that are connected to ... | When racks are front-loaded onto the sample presentation unit while samples from the automation l... | Class II | Beckman Coulter Inc. |
| Dec 5, 2018 | UniCel DxC 660i, 680i, 860i, and 880i SYNCHRON Access Clinical Systems, that ... | When racks are front-loaded onto the sample presentation unit while samples from the automation l... | Class II | Beckman Coulter Inc. |
| Nov 9, 2018 | AutoMate 1250, Sorter with Aliquot Module - UDI: 15099590364106; Model #ODL25... | Beckman Coulter has identified a case where a customer using the microltiterplate kit option with... | Class II | Beckman Coulter Inc. |
| Oct 18, 2018 | iChem VELOCITY Urine Chemistry Strips, REF 800-7212, 100 test strips/vial. T... | Falsely elevated (false positive) urobilinogen patient results due to an increase in the sensitiv... | Class II | Beckman Coulter Inc. |
| Sep 18, 2018 | The Access Cortisol Reagent. REF (Catalog Number) 33600, Lot 831755. A param... | Cross contamination may have occurred between wells for the reagent pack. As a result of this def... | 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. |
| Aug 24, 2018 | Beckman Coulter Uric Acid, REF OSR6098, OSR6198, and OSR6698. | NAPQI, a metabolite of Acetominophen, causes negative interference with the recalled product assa... | Class II | Beckman Coulter Inc. |
| Aug 24, 2018 | Beckman Coulter Lipase, REF OSR6130 and OSR6230. | NAPQI, a metabolite of Acetaminophen, causes negative interference with the recalled product assa... | Class II | Beckman Coulter Inc. |
| Jul 30, 2018 | UniCel DxH 900 Coulter Cellular Analysis System, REF number C11478 Product... | Complaints received of sporadic erroneously elevated platelet results without flags or system mes... | Class I | Beckman Coulter Inc. |
| Jul 30, 2018 | UniCel DxH 600 Coulter Cellular Analysis System, REF number B23858. Produc... | Complaints received of sporadic erroneously elevated platelet results without flags or system mes... | Class I | Beckman Coulter Inc. |
| Jul 30, 2018 | UniCel DxH 800 Coulter Cellular Analysis System, REF numbers 629029, B24465, ... | Complaints received of sporadic erroneously elevated platelet results without flags or system mes... | Class I | Beckman Coulter Inc. |
| May 24, 2018 | Software Package, iPAW 4.2.1 User Kit for Windows XP and Windows 10, Part No.... | 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 | Software Package, Sorting-Drive 4.2.1 User Kit for Windows XP and Windows 10... | Sorting-Drive software version 4.2 (released in October 2015) introduced a new option which inclu... | Class III | Beckman Coulter Inc. |
| May 24, 2018 | Software Package, iPAW 4.2 User Kit, Part No. B73489, Manufactured by: Beckma... | 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 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. |
| May 24, 2018 | Software Package, Sorting-Drive 4.2 User Kit, Part No. B73488, Manufactured b... | Sorting-Drive software version 4.2 (released in October 2015) introduced a new option which inclu... | Class III | Beckman Coulter Inc. |
| May 4, 2018 | MicroScan Pos Combo Panel Type 43, Catalog number B1017-217for use in determi... | The drug dilution sequence for Moxifloxacin printed on the panel is incorrect. As a result, incor... | Class II | Beckman Coulter Inc. |
| Mar 29, 2018 | iChem VELOCITY Automated Urine Chemistry System, Catalog #700-7176-001 and iC... | The Strip Provider Modules (SPM) on some of the instruments had not been inspected during manufac... | Class II | Beckman Coulter Inc. |
| Mar 26, 2018 | BECKMAN COULTER MicroScan MICroSTREP Plus Panel, MicroScan Mueller-Hinton Bro... | Beckman Coulter has received customer complaints of lowered minimum inhibitory concentration (MIC... | Class II | Beckman Coulter Inc. |
| Mar 2, 2018 | BECKMAN COULTER iQ200 Series Urine Microscopy Analyzer, Catalog Numbers: 70... | Beckman Coulter has determined that there is a potential for under-reporting casts. This can occu... | Class II | Beckman Coulter Inc. |
| Mar 2, 2018 | BECKMAN COULTER iChemVELOCITY, Urine Chemistry System, Catalog Numbers: 800-... | Beckman Coulter has determined that there is a potential for incorrect settings to be installed o... | Class II | Beckman Coulter Inc. |
| Jan 29, 2018 | AQUIOS CL Flow Cytometer System, Catalog #B30166. The AQUIOS CL Flow Cytomet... | The device may process the same sample with two different sample IDs and sample information while... | Class II | Beckman Coulter Inc. |
| Jan 19, 2018 | AutoMate 1200 Catalog Number ODL25120; AutoMate 1250 Catalog Number ODL25125... | Belts on the x-axis (and on the y-axis, to a lesser extent) manufactured from 2015 are showing pr... | Class II | Beckman Coulter Inc. |
| Jan 18, 2018 | AutoMate 2550 "High Speed" Catalog Number ODL25255; AutoMate 1250 "Standar... | A misaligned pipette tip sensor poses the remote risk of cross-contamination when failing to caus... | 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.