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 |
|---|---|---|---|---|
| Nov 6, 2017 | UniCel DxC 600i SYNCHRON Access Clinical Systems; A25656, A25638. In vitro... | Potential for minor skin burn if the tool contacts the reagent storage interface board (B79917) w... | Class III | Beckman Coulter Inc. |
| Nov 6, 2017 | Access 2 Immunoassay System, Catalog Number 81600N. In vitro diagnostic de... | Potential for minor skin burn if the tool contacts the reagent storage interface board (B79917) w... | Class III | Beckman Coulter Inc. |
| Nov 3, 2017 | UniCel DxH Slidemaker Stainer, Part Number 75222, for use with automated hema... | The shield for the Single-Tube Station on the DxH instrument may interfere with sample aspiration... | Class II | Beckman Coulter Inc. |
| Nov 3, 2017 | UniCel DxH600, Part Number B23858, automated hematology analyzer (Note: ... | The shield for the Single-Tube Station on the DxH instrument may interfere with sample aspiration... | Class II | Beckman Coulter Inc. |
| Nov 3, 2017 | UniCel DxH800, Part Numbers: 629029 and B24802, automated hematology analyzer | The shield for the Single-Tube Station on the DxH instrument may interfere with sample aspiration... | Class II | Beckman Coulter Inc. |
| Oct 2, 2017 | AQUIOS CL Flow Cytometer, Catalog No. B30166, Rx. The firm name on the labe... | The system may duplicate sample requests leading to sample misidentification when connected to a ... | Class II | Beckman Coulter Inc. |
| Aug 24, 2017 | Lyophilized Chemistry Calibrator Level 1 Product Usage: Beckman Coulter ... | Unpaired lots of AU lyophilized chemistry calibrator level 1 and 2 have been distributed. Calibra... | Class II | Beckman Coulter Inc. |
| Aug 21, 2017 | AQUIOS CL Flow Cytometer System The AQUIOS CL Flow Cytometer is intended f... | Beckman Coulter has identified that an incorrect setting using a proprietary software configurati... | Class II | Beckman Coulter Inc. |
| Aug 3, 2017 | Power Processor 1K Stockyard. The Power Processor performs all pre-analyti... | Beckman Coulter has identified that due to a PLC software nonconformity the 1K Stockyard can ini... | Class II | Beckman Coulter Inc. |
| Jul 20, 2017 | Sekisui Diagnostics Sekure Chemistry Acetaminophen L3K , Ref. 506-30. The fi... | Reagent carryover from Sekisui ACTH when utilized on the BEC AU 680 analyzer may lead to falsely ... | Class II | Beckman Coulter Inc. |
| Jun 26, 2017 | Coulter LH 750, Coulter LH 780, and Coulter LH 500 Analyzers Hematology Anal... | Beckman Coulter has determined that additional clarification for the Blast Suspect messages is ne... | Class II | Beckman Coulter Inc. |
| Jun 26, 2017 | Coulter HmX CP and Coulter HmX AL Analyzers The purpose of the HmX Hematolog... | Beckman Coulter has determined that additional clarification for the Blast Suspect messages is ne... | Class II | Beckman Coulter Inc. |
| Jun 20, 2017 | UniCel DxH Slidemaker Stainer Coulter Cellular Analysis System, Software Vers... | The firm has identified that a fitting in some Slidemaker Stainer units may not completely seal a... | Class II | Beckman Coulter Inc. |
| May 22, 2017 | Coulter PrepPlus 2, Part Number 378600, Product Usage: The COULTER PrepP... | When samples are prepared using the PrepPlus or PrepPlus 2 sample preparation systems and then ru... | Class II | Beckman Coulter Inc. |
| May 22, 2017 | Coulter PrepPlus, Part Number 286600, Product Usage: The COULTER PrepPlu... | When samples are prepared using the PrepPlus or PrepPlus 2 sample preparation systems and then ru... | Class II | Beckman Coulter Inc. |
| May 9, 2017 | Access System-Free T4 Assay, B01902E, Catalog No. 33880 | The Access immunoassays are susceptible to biotin interference. | Class II | Beckman Coulter Inc. |
| May 9, 2017 | Access Total T3, A34435H, Catalog No. 33830 | The Access immunoassays are susceptible to biotin interference. | Class II | Beckman Coulter Inc. |
| May 9, 2017 | Access Thyroglobulin, A34085G, Catalog No. 33860 | The Access immunoassays are susceptible to biotin interference. | Class II | Beckman Coulter Inc. |
| May 9, 2017 | Access System-GI Monitor (CA19-9), A83873D, Catalog No. 387687 | The Access immunoassays are susceptible to biotin interference. | Class II | Beckman Coulter Inc. |
| Apr 24, 2017 | UniCel DxH 800 Coulter Cellular Analysis System, Catalog No. 629029, B24465, ... | There is a possibility of a data acquisition disruption that may cause an unusual light scatter e... | Class II | Beckman Coulter Inc. |
| Apr 24, 2017 | UniCel DxH 600 Coulter Cellular Analysis System, Catalog No. B23858. | There is a possibility of a data acquisition disruption that may cause an unusual light scatter e... | Class II | Beckman Coulter Inc. |
| Apr 24, 2017 | Microalbumin Reagent, Catalog No. 475100, Product Labeling A18520AL MA reage... | Beckman Coulter has confirmed that MA Reagent Lot M609458 may recover outside the lower limit of ... | Class II | Beckman Coulter Inc. |
| Apr 13, 2017 | Access BR Monitor, Part No. 387620 | Following biases observed in the results of the French National Quality Controls, Beckman Coulter... | Class II | Beckman Coulter Inc. |
| Apr 3, 2017 | Lactate Reagent (LACT 2 x 50), Catalog No. A95550 Intended for the quantit... | Beckman Coulter has identified the following drugs as potential sources of interference: Metamizo... | Class II | Beckman Coulter Inc. |
| Apr 3, 2017 | Uric Acid Reagent (URIC 2 x 300), Catalog No. 442785. Intended for the qua... | Beckman Coulter has identified the following drugs as potential sources of interference: Metamizo... | Class II | Beckman Coulter Inc. |
| Apr 3, 2017 | Triglycerides Reagent (TG 2 x 300), Catalog No. 445850. Intended for quant... | Beckman Coulter has identified the following drugs as potential sources of interference: Metamizo... | Class II | Beckman Coulter Inc. |
| Apr 3, 2017 | AQUIOS CL Flow Cytometer, Ref no. B30166, Software Versions 2.0 and 2.0.1 ... | Beckman Coulter has confirmed that the Export feature located in the Results area of the AQUIOS S... | Class II | Beckman Coulter Inc. |
| Apr 3, 2017 | Cholesterol Reagent(CHOL 2 x 300), Catalog No. 467825 Intended for quantit... | Beckman Coulter has identified the following drugs as potential sources of interference: Metamizo... | Class II | Beckman Coulter Inc. |
| Apr 3, 2017 | HDL Cholesterol Reagent (HDL 2 x 200), Catalog No. A15625. Intended for qu... | Beckman Coulter has identified the following drugs as potential sources of interference: Metamizo... | Class II | Beckman Coulter Inc. |
| Apr 3, 2017 | Salicylate Reagent (SALY 2 x 45), Catalog No. 378194. Intended for quantit... | Beckman Coulter has identified the following drugs as potential sources of interference: Metamizo... | Class II | Beckman Coulter Inc. |
| Apr 3, 2017 | Enzymatic Creatinine Reagent (CR-E 2 x 200), Catalog No. A60298. Intended ... | Beckman Coulter has identified the following drugs as potential sources of interference: Metamizo... | Class II | Beckman Coulter Inc. |
| Mar 10, 2017 | Access Ferritin Calibrators, Part No. 33025, Ref No. B50136C | Beckman Coulter is recalling the Access Ferritin Calibrators kit because it contains a calibratio... | Class II | Beckman Coulter Inc. |
| Mar 7, 2017 | Access 2 Immunoassay Systems, Part No. 81600N Product Usage: The Access 2... | Beckman Coulter is recalling the Access 2 Family of Immunoassay Systems because a circuit board t... | Class II | Beckman Coulter Inc. |
| Mar 7, 2017 | UniCel DxC 600i SYNCHRON Access Clinical System, Part No. A25637, A25638 P... | Beckman Coulter is recalling the Access 2 Family of Immunoassay Systems because a circuit board t... | Class II | Beckman Coulter Inc. |
| Mar 7, 2017 | Access 2 assay Immunoassay System, Remanufactured, Part No. 386220 Product... | Beckman Coulter is recalling the Access 2 Family of Immunoassay Systems because a circuit board t... | Class II | Beckman Coulter Inc. |
| Feb 13, 2017 | Beckman Coulter Chemistry Analyzer AU680/AU5800, Catalog No. MU907400 (Rack I... | Beckman Coulter is recalling the Rack ID Labels because the Rack ID number displayed and the Rack... | Class II | Beckman Coulter Inc. |
| Jan 30, 2017 | iChemVELOCITY Urine Chemistry System, Catalog No. 800-3530, 800-7167, 800-771... | The probe misalignment or bending has the potential to lead to delay in reporting results or inco... | Class II | Beckman Coulter Inc. |
| Dec 21, 2016 | AutoMate 2500 Family Catalog No. ODL25120 AutoMate 1200, ODL25125, AutoMate 1... | Beckman Coulter initiated a design change to update the Automate PC image to accommodate the oper... | Class III | Beckman Coulter Inc. |
| Dec 19, 2016 | UniCel DxH 800 Coulter Cellular Analysis System, Catalog No. 629029, B24465,... | Beckman Coulter has determined that additional clarification for the Blast Suspect messages is ne... | Class II | Beckman Coulter Inc. |
| Dec 19, 2016 | DxH 600 Coulter Cellular Analysis System, Catalog No. B23858 | Beckman Coulter has determined that additional clarification for the Blast Suspect messages is ne... | Class II | Beckman Coulter Inc. |
| Oct 25, 2016 | MicroScan LabPro Data Management System. Intended to manage both microbial... | Beckman Coulter has received and confirmed reports of an intermittent and unexpected behavior whe... | Class II | Beckman Coulter Inc. |
| Oct 24, 2016 | Access Ostase QC, Catalog No. 37309, B83877 Product Usage: The Access O... | Beckman Coulter has determined that the Access Ostase Calibrator and Access Ostase QC lots do not... | Class II | Beckman Coulter Inc. |
| Oct 24, 2016 | Access Ostase Calibrators, Catalog No. 37305, B83876 Product Usage: The A... | Beckman Coulter has determined that the Access Ostase Calibrator and Access Ostase QC lots do not... | Class II | Beckman Coulter Inc. |
| Oct 19, 2016 | AQUIOS Lyse Reagent Kit, Catalog No. B23538 Product Usage: AQUIOS Lysing ... | Beckman Coulter is recalling the AQUIOS Lyse Reagent Kit because it may lead to an increased gene... | Class II | Beckman Coulter Inc. |
| 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. |
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.