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.

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DateProductReasonClassFirm
Sep 6, 2016 AQUIOS CL Flow Cytometer, Catalog No. B30166; Intended for use with in vitro ... Beckman Coulter is recalling the AQUIOS CL System because the use of the reagent carousel can lea... Class II Beckman Coulter Inc.
Aug 8, 2016 UniCel DxH 800 and DxH 600 Coulter Cellular Analysis System. Catalog No. 6... There is a possibility of specimen misidentification for the stand-alone DxH 800 and DxH 600 wher... Class II Beckman Coulter Inc.
Aug 4, 2016 UniCel DxH Slidemaker Stainer Coulter Cellular Analysis System, Catalog No. 7... Beckman Coulter is recalling the UniCel DxH Slidemaker Stainer Coulter Cellular Analysis System t... Class II Beckman Coulter Inc.
Jun 27, 2016 The Synchron Systems No Foam DxC (Reference No. B64130) affects the UniCel Dx... Beckman Coulter has identified an incompatibility between No Foam DxC reagent (REF B64130) and th... Class II Beckman Coulter Inc.
Jun 8, 2016 Access Free T3 Assay, Ref No. A13422 The Access Free T3 assay is a paramag... Demonstrate an upward shift in patient results. Class II Beckman Coulter Inc.
May 17, 2016 Access 2 Immunoassay System, Remanufactured, Catalog No. 386220 is an invitro... Due to the lack of updated thermal components, these instruments may be more susceptible to the i... Class II Beckman Coulter Inc.
Apr 13, 2016 Uric Acid, Catalog No. OSR6x98 Product Usage:Uric acid OSR6x98 is intended... Beckman Coulter has identified that Dipyrone (Metamizole) may cause erroneous, false low results ... Class II Beckman Coulter Inc.
Apr 13, 2016 Triglyceride, Catalog No. OSR6x118 Product Usage:Triglyceride OSR6x118 is ... Beckman Coulter has identified that Dipyrone (Metamizole) may cause erroneous, false low results ... Class II Beckman Coulter Inc.
Apr 13, 2016 Lipase, Catalog No. OSR6x30 Product Usage: Lipase OSR6x30 is intended as ... Beckman Coulter has identified that Dipyrone (Metamizole) may cause erroneous, false low results ... Class II Beckman Coulter Inc.
Apr 13, 2016 Cholesterol, Catalog No. OSR6x16 Product Usage:Cholesterol OSR6x16 is inte... Beckman Coulter has identified that Dipyrone (Metamizole) may cause erroneous, false low results ... Class II Beckman Coulter Inc.
Apr 13, 2016 Lactate, Catalog No. OSR6x93 Product Usage: Lactate OSR6x93 is intended a... Beckman Coulter has identified that Dipyrone (Metamizole) may cause erroneous, false low results ... Class II Beckman Coulter Inc.
Feb 11, 2016 MicroScan LabPro Information Manager System, Software Versions 1.0 to 4.41 ... Beckman Coulter is recalling the MicroScan LabPro Information Manager System because the software... Class II Beckman Coulter Inc.
Feb 5, 2016 Allegra X-5 rotor yoke, Catalog No. (Instruments) B30589 and B30590 (Rotor) B... A defective rotor yoke on Allegra X-5 allows improper rotor seating on the hub resulting in possi... Class II Beckman Coulter Inc.
Jan 13, 2016 iChem VELOCITY Automated Urine Chemistry, Catalog No. 800-3049, 800-3050, 800... Iris International noted loose or missing analyte pads found in several locations (strip vial, s... Class II Beckman Coulter Inc.
Dec 1, 2015 MicroScan Pos Combo Panel Type 34, Part No. B1017-214 MicroScan Pos (Posit... Beckman Coulter has confirmed falsely negative results for Voges-Proskauer (VP) (pale-pink/brown/... Class II Beckman Coulter Inc.
Dec 1, 2015 UniCel DxH 800 Coulter Cellular Analysis System, Software Version 3.0.2.0, Pa... Beckman Coulter is recalling the DxH 800 Slidemaker Stainer Software version 3.0.2.0 and DxH 600 ... Class II Beckman Coulter Inc.
Dec 1, 2015 MicroScan Pos Breakpoint Combo Panel Type 23, Part No. B1017-206 MicroScan... Beckman Coulter has confirmed falsely negative results for Voges-Proskauer (VP) (pale-pink/brown/... Class II Beckman Coulter Inc.
Dec 1, 2015 MicroScan Pos Combo Panel Type 21, Part No. B1017-201 MicroScan Pos (Posit... Beckman Coulter has confirmed falsely negative results for Voges-Proskauer (VP) (pale-pink/brown/... Class II Beckman Coulter Inc.
Dec 1, 2015 UniCel DxH 600 Coulter Cellular Analysis System, Software Version 1.1.1.0, Pa... Beckman Coulter is recalling the DxH 800 Slidemaker Stainer Software version 3.0.2.0 and DxH 600 ... Class II Beckman Coulter Inc.
Dec 1, 2015 MicroScan Pos Combo Panel Type 33, Part No. B1017-211 MicroScan Pos (Posit... Beckman Coulter has confirmed falsely negative results for Voges-Proskauer (VP) (pale-pink/brown/... Class II Beckman Coulter Inc.
Dec 1, 2015 MicroScan Pos Breakpoint Combo Panel Type 20, Part No. B1017-202 MicroScan... Beckman Coulter has confirmed falsely negative results for Voges-Proskauer (VP) (pale-pink/brown/... Class II Beckman Coulter Inc.
Dec 1, 2015 UniCel DxH 600 Coulter Cellular Analysis System, Software Version 3.0.2.0, Pa... Beckman Coulter is recalling the DxH 800 Slidemaker Stainer Software version 3.0.2.0 and DxH 600 ... Class II Beckman Coulter Inc.
Oct 13, 2015 Access CEA Assay, Part No. 33200. For the quantitative determination of Carc... Beckman Coulter is recalling the Access CEA reagent packs because they were filled incorrectly. Class II Beckman Coulter Inc.
Sep 10, 2015 MICroSTREP plus 2 Panel, Part No. B1027-202 Product Usage: MicroScan MICr... Beckman Coulter is recalling MICroSTREP plus 1 and MICroSTREP plus 2 panels because a manufacturi... Class II Beckman Coulter Inc.
Sep 10, 2015 MICroSTREP plus 1 Panel, Part No. B1027-201 Product Usage: MicroScan MICr... Beckman Coulter is recalling MICroSTREP plus 1 and MICroSTREP plus 2 panels because a manufacturi... Class II 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 30, 2015 AU480 Chemistry Analyzers, Reference No. B28624 The AU series are automated,... Beckman coulter has received complaints regarding leaking and cracked C cups. When the cup cracks... Class II Beckman Coulter Inc.
Jul 30, 2015 AU5800 Chemistry Analyzers, Reference No. A98352 The AU series are automated... Beckman coulter has received complaints regarding leaking and cracked C cups. When the cup cracks... Class II Beckman Coulter Inc.
Jul 30, 2015 AU680 Chemistry Analyzers, Reference No. B04779 The AU series are automated,... Beckman coulter has received complaints regarding leaking and cracked C cups. When the cup cracks... 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.
Jul 22, 2015 COULTER LH Series Diluent, Catalog No. 8547194, Product Labeling A40192-AD. ... Beckman Coulter is recalling the LH 750 and LH780 Hematology Systems because the use of the dilue... Class II Beckman Coulter Inc.
Jul 22, 2015 COULTER ISOTON 4 Diluent, Catalog No. 8547148. The diluent provides the abil... Beckman Coulter is recalling the LH 750 and LH780 Hematology Systems because the use of the dilue... Class II Beckman Coulter Inc.
Jul 17, 2015 MicroScan LabPro Information Manager System, Version 1.0 to Version 4.11, Cat... The software incorrectly allows the operator to manually edit the carbohydrate substrates when ma... Class II Beckman Coulter Inc.
Apr 13, 2015 COULTER DxH Diluent, Catalog No. 628017, Part No. A59956. For use as an is... Beckman Coulter has received an increased number of complaints related to Hemoglobin (HGB) on Uni... Class II Beckman Coulter Inc.
Dec 15, 2014 Beckman Coulter, Lipase Assay, Catalog No. OSR6X30 N-Acetyl Cysteine (NAC), when administered in therapeutic concentrations for the treatment of ace... Class II Beckman Coulter Inc.
Dec 15, 2014 Beckman Coulter, Lactate Assay, Catalog No. OSR6X93 N-Acetyl Cysteine (NAC), when administered in therapeutic concentrations for the treatment of ace... Class II Beckman Coulter Inc.
Dec 15, 2014 Beckman Coulter, Uric Acid Assay, Catalog No. OSR6X98 N-Acetyl Cysteine (NAC), when administered in therapeutic concentrations for the treatment of ace... Class II Beckman Coulter Inc.
Dec 15, 2014 Beckman Coulter, Cholesterol Assay, Catalog No. OSR6X16 N-Acetyl Cysteine (NAC), when administered in therapeutic concentrations for the treatment of ace... Class II Beckman Coulter Inc.
Dec 8, 2014 iChem 10 SG Urine Chemistry Strips, PN 800-7005. Intended for the in vitro... Iris International is recalling the iChem 10 SG Urine Chemistry Strip because of false positive l... Class II Beckman Coulter Inc.
Oct 6, 2014 UniCel DxC 600i SYNCHRON Access Clinical Analyzer, Catalog No. A25640, Instru... Beckman Coulter is recalling the Small Form Factor Console PC (SFF PC) (B23083) for use with the ... Class II Beckman Coulter Inc.
Oct 6, 2014 Access 2 Immunoassay Systems, Catalog No. 81600N, 386220, Instructions for Us... Beckman Coulter is recalling the Small Form Factor Console PC (SFF PC) (B23083) for use with the ... Class II Beckman Coulter Inc.
Aug 25, 2014 Coulter DxH Diluent, Catalog No. 628017 Blood cell analysis comprises dilu... Beckman Coulter is recalling Coulter DxH Diluent because it may be associated with elevated plate... Class II Beckman Coulter Inc.
Aug 21, 2014 UniCel 600/800 Access Immunoassay Systems are in vitro diagnostic devices use... Beckman Coulter is recalling the Sample Probe Cable because nonconforming sample probe cables may... Class II Beckman Coulter Inc.
May 14, 2014 Ultrasonic Transducer Kits For use with the Access Family of Immunoassay Sys... Beckman Coulter is initiating a field action because some Ultrasonic Transducer Kits were pote... Class II Beckman Coulter Inc.
Apr 22, 2014 UniCel DxC Synchron Clinical Systems and UniCel DxC Synchron Access Integrate... Possible leaking of No Foam solution from the No Foam Bottle Assembly on the UniCel DxC Synchron ... Class II Beckman Coulter Inc.
Nov 26, 2013 Access 2 Immunoassay System Analyzer. The Access Immunoassay System is ... The Access 2 Immunoassay System Analyzer and the UniCel DxI 600 Access may have been manufactured... Class II Beckman Coulter Inc.
Nov 26, 2013 UniCel DxI 600 Access Immunoassay System Analyzer. The Access Immunoassay... The Access 2 Immunoassay System Analyzer and the UniCel DxI 600 Access may have been manufactured... Class II Beckman Coulter Inc.
Nov 8, 2013 Coulter DxH Cleaner 10L, Part No. 628023. For use on UniCel DxH Systems fo... Beckman Coulter is recalling the UniCel DxH800 and UniCel DxH600 Coulter Analysis Systems because... Class II Beckman Coulter Inc.
Nov 8, 2013 Coulter LH 750 Hematology Analyzer, Part No. 6605632, A85570 Product Usag... Beckman Coulter is recalling the LH 750 and LH 780 Hematology Systems because the optical degrada... Class II Beckman Coulter Inc.
Nov 8, 2013 Coulter DxH Cleaner 5L, Part No. 628022. For use on UniCel DxH Systems for... Beckman Coulter is recalling the UniCel DxH800 and UniCel DxH600 Coulter Analysis Systems because... 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.