Browse Device Recalls

242 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 242 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 242 FDA device recalls.

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DateProductReasonClassFirm
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.
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.
Jan 12, 2018 COULTER EPICS XL Flow Cytometer COULTER EPICS XL-MCL Flow Cytometer SYSTEM ... A manufacturing defect on the amplifier board of the Flow Cytometers my cause signal loss and/or ... Class I Beckman Coulter Inc.
Jan 12, 2018 1) Cytomics FC 500 With CXP Software BECKMAN COULTER 2) Cytomics FC 500 M... A manufacturing defect on the amplifier board of the Flow Cytometers my cause signal loss and/or ... Class I Beckman Coulter Inc.
Dec 4, 2017 iChem VELOCITY Urine Chemistry Strips, REF 800-7212 Product Usage: The iC... A subset of Lot 7212154 A of the iChem VELOCITY Urine Chemistry strips has an incorrect pad pla... Class II Beckman Coulter Inc.
Nov 10, 2017 iQ200 Series Urine Microscopy Analyzer with Barcode Reader Model NFT-2100, Ca... iQ200 Series Urine Microscopy Analyzer may intermittently fail to read urine sample dilution barc... Class II Beckman Coulter Inc.
Nov 6, 2017 Access 2 Immunoassay System, Remanufactured, Catalog Number 386220. In vit... Potential for minor skin burn if the tool contacts the reagent storage interface board (B79917) w... Class III 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.