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.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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. |
| Nov 8, 2013 | Coulter LH 780 Hematology Analyzer, Part No. 723585, A90728 Product Usage... | Beckman Coulter is recalling the LH 750 and LH 780 Hematology Systems because the optical degrada... | Class II | Beckman Coulter Inc. |
| Nov 8, 2013 | UniCel DxH 600 Coulter Cellular Analysis System, Part No. B23858. Used for... | Beckman Coulter is recalling the UniCel DxH800 and UniCel DxH600 Coulter Analysis Systems because... | Class II | Beckman Coulter Inc. |
| Nov 8, 2013 | UniCel DxH 800 Coulter Cellular Analysis System, Part No. 629029, B24465, a... | Beckman Coulter is recalling the UniCel DxH800 and UniCel DxH600 Coulter Analysis Systems because... | Class II | Beckman Coulter Inc. |
| Oct 2, 2013 | Access Immunoassay Systems Reaction Vessels. The Access Immunoassay System... | Beckman Coulter is initiating a recall for the Access Immunoassay Systems Reaction Vessels, inclu... | Class II | Beckman Coulter Inc. |
| Sep 24, 2013 | COULTER LH 750 and LH 780 Analyzers. The COULTER LH 750 Hematology Analyz... | The check valves may fail on the Coulter LH 750 Hematology Analyzer (PN 6605632 and A85570) and C... | Class II | Beckman Coulter Inc. |
| Sep 24, 2013 | UniCel DxH 800 and DxH 600 Coulter Cellular Analysis Systems The UniCel Dx... | Beckman Coulter is initiating a recall for UniCel DxH 800 Coulter Cellular Analysis System (PN 62... | 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.