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
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.
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 15, 2017 Beckman Coulter Synchron AQUA CAL Level 1, Part No. 471288 Product Usage: ... The firm identified a negative shift of 5mmol/L for sodium recovery in Synchron Control Level 3 w... 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.

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.