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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
Sep 12, 2013 Access 2 Immunoassay System, Part Number: 81600N The Access Immunoassay Sy... Beckman Coulter is recalling the Access 2 Immunoassay System because they determined that the fus... Class II Beckman Coulter Inc.
Sep 9, 2013 ISE REF Valve, Part No. MU3226 for the AU400, AU640, AU2700, and AU5400 Chemi... The recall was initiated because Beckman Coulter has confirmed that some AU Clinical Chemistry An... Class II Beckman Coulter Inc.
Sep 9, 2013 ISE REF Valve, Part No. MU7638 for the AU480, AU680, and AU5800 Chemistry Ana... The recall was initiated because Beckman Coulter has confirmed that some AU Clinical Chemistry An... Class II Beckman Coulter Inc.
Jul 17, 2013 Hemoccult ICT (Immunochemical Fecal Occult Blood Test) is a rapid, visually r... Beckman Coulter has received a customer complaint that suggests trending of positive results has... Class II Beckman Coulter Inc.
Jun 3, 2013 AU5800 Clinical Chemistry Analyzer with Automation Ready Connection (All Soft... The recall was initiated because Beckman Coulter has identified a software error on AU5800 analyz... Class II Beckman Coulter Inc.
May 28, 2013 SYNCHRON System(s) Lactate (LACT) Reagent. Product Usage: Lactate (LACT) ... Beckman Coulter has confirmed customer reports of LACT Lot M210077 failing calibration with erro... Class II Beckman Coulter Inc.
Apr 26, 2013 AU2700 Clinical Chemistry Analyzer AU5400 Clinical Chemistry Analyzer Per... Beckman Coulter is recalling AU2700/AU2700 Plus & AU5400 Clinical Chemistry Analyzers becuase it ... Class II Beckman Coulter Inc.
Apr 17, 2013 Synchron LX System(s) and UniCel DxC 600/800 System(s) Lactate Reagent, Part ... Beckman Coulter initiated the recall for the Lactate Assay (LACT) Lot M206209 as they received a ... Class II Beckman Coulter Inc.
Mar 20, 2013 AU5800 Clinical Chemistry Analyzer The Beckman Coulter AU5800 Clinical Che... Beckman Coulter, Inc. initiated this recall because there is a software error that has the potent... Class II Beckman Coulter Inc.
Feb 12, 2013 Synchron LXi 725 Clinical System; P/N 107405S Product Usage: The Access... Beckman Coulter is initiating a recall due to a defective newly released aluminum incubator belt ... Class II Beckman Coulter Inc.
Feb 12, 2013 UniCel DxC 600i Synchron Access Clinical System; P/N 107405S Product Usage... Beckman Coulter is initiating a recall due to a defective newly released aluminum incubator belt ... Class II Beckman Coulter Inc.
Feb 12, 2013 Access 2 Immunoassay System; P/N 107405S 2/12 The Access Immunoassay Syste... Beckman Coulter is initiating a recall due to a defective newly released aluminum incubator belt ... Class II Beckman Coulter Inc.
Feb 12, 2013 Access Immunoassay System; P/N 107405S Product Usage: The Access Immu... Beckman Coulter is initiating a recall due to a defective newly released aluminum incubator belt ... Class II Beckman Coulter Inc.
Dec 28, 2012 Creatinine, Part Numbers OSR6178, OSR6678 Product Usage: System reag... Beckman Coulter is including additional information and instructions in the Creatinine (OSR6x78) ... Class II Beckman Coulter Inc.
Nov 28, 2012 Beckman Coulter AU5800 Clinical Chemistry Analyzer. An automated chemistry an... Due to a software data storage limitation which only occurs under certain conditions, measurement... Class II Beckman Coulter Inc.
Nov 5, 2012 The Access hLH assay is a paramagnetic particle, chemiluminescent immunoassay... Beckman Coulter Inc. (BEC) has demonstrated that real time stability testing of hLH Calibrator of... Class II Beckman Coulter Inc.
Nov 1, 2012 Access Immunoassay System, Access 2 Immunoassay System, Synchron LXi 725 Cl... It has been determined that, in some cases, pulley drive components have broken parts or have be... Class II Beckman Coulter Inc.
Oct 26, 2012 Beckman Coulter AU5800 Clinical Chemistry Analyzer, All Serial Numbers. An... Beckman Coulter is recalling the AU8500 Clinical Chemistry Analyzer because there is no labeling ... Class II Beckman Coulter Inc.
Sep 3, 2012 UniCel¿ DxC 600/800 with Software v5.0.11, Part Number B12218. The UniCel... Beckman Coulter has confirmed that the Shuttle to Barcode Reader and Cap Piercer alignment proce... Class II Beckman Coulter Inc.
Jul 24, 2012 Access Folate Calibrators, Part Number: A14207. The Access Folate assay is... Beckman Coulter is recalling the Access Folate Calibrators because it may produce falsely elevate... Class II Beckman Coulter Inc.
Jul 24, 2012 Access Folate WHO Calibrators, Part Number: A98033. The Access Folate Cali... Beckman Coulter is recalling the Access Folate Calibrators because it may produce falsely elevate... Class II Beckman Coulter Inc.
Jul 6, 2012 Unicel Closed Tube Aliquotter (UCTA) for UniCel DxC 660i, UniCel DxC 680i, Un... The recall was initiated because Beckman Coulter has confirmed that the current sample syringe pu... Class II Beckman Coulter Inc.
May 22, 2012 CYTO-STAT tetraCHROME CD45- FITC/CD56-RD1/CD19-ECD/CD3-PC5, Part Number 66070... The recall was initiated because Beckman Coulter has determined that the specimen and prepared sa... Class II Beckman Coulter Inc.
May 22, 2012 TetraCXP Software System, Part Number A40051. Allows simultaneous identifi... The recall was initiated because Beckman Coulter has determined that the specimen and prepared sa... Class II Beckman Coulter Inc.
May 22, 2012 CYTO-STAT tetraCHROME CD45-FITC/CD4-RD1/CD8-ECD/CD3-PC5, Part Number 6607013.... The recall was initiated because Beckman Coulter has determined that the specimen and prepared sa... Class II Beckman Coulter Inc.
Apr 11, 2012 AutoMate 1250 and AutoMate 2550, Part Numbers ODL25125 and ODL25255. The A... The recall was initiated because Beckman Coulter has confirmed customer reports of secondary tube... Class II Beckman Coulter Inc.
Apr 3, 2012 Unicel DxH 800 Coulter Cellular Analysis System, Part Number 629029. The U... Beckman Coulter is recalling the UniCel DxH 800 Coulter Cellular Analysis System because the NRBC... Class II Beckman Coulter Inc.
Jan 27, 2012 IMMAGE Immunochemistry Systems Rheumatoid Factor (RF) Reagent, PN 447070 T... The recall was initiated because Beckman Coulter has confirmed customer reports of QC shifts, lot... Class II Beckman Coulter Inc.
Jan 20, 2012 Active Renin IRMA Kit, Part Number DSL25100 Product Usage: The Renin IRMA... The recall was initiated because Beckman Coulter has confirmed that the Active Renin IRMA Test Ki... Class II Beckman Coulter Inc.
Jan 20, 2012 COULTER PrepPlus, Part Number: 286600 Product Usage: The COULTER PrepPlus... The recall was initiated because Beckman Coulter has confirmed that the Coulter PrepPlus may expe... Class II Beckman Coulter Inc.
Dec 15, 2011 Synchron Systems Synchron Calibrator Multi Calibrator Diskettes, Part Number ... The recall was initiated because Beckman Coulter has confirmed a mislabeling error, some Synchron... Class III Beckman Coulter Inc.
Dec 13, 2011 UniCel DxH Slidemaker Stainer Stainer Floor Cabinet, PN A96152. The DxH Sl... The recall was initiated because Beckman Coulter has confirmed that the DxH Slidemaker Stainer Fl... Class II Beckman Coulter Inc.
Dec 13, 2011 UniCel DxH Slidemaker Stainer Instrument System, PN 775222. The DxH Slidem... The recall was initiated because Beckman Coulter has confirmed that the DxH Slidemaker Stainer Fl... Class II Beckman Coulter Inc.
Oct 13, 2011 UniCel DxC 660i, 680i, 860i, 880i SYNCHRON Access Clinical Systems, Part Nu... The recall was initiated because Beckman Coulter has received seven reports of a software anomaly... Class II Beckman Coulter Inc.
Oct 13, 2011 UniCel DxI 800 Access Immunoassay Systems, Part Numbers: Dxl 800: 937100; D... The recall was initiated because Beckman Coulter has received seven reports of a software anomaly... Class II Beckman Coulter Inc.
Oct 13, 2011 UniCel DxI 600 Access Immunoassay Systems, Part Numbers: Dxl 600: A30260; ... The recall was initiated because Beckman Coulter has received seven reports of a software anomaly... Class II Beckman Coulter Inc.
Oct 11, 2011 Access Total T3 Reagent, PN: 33830 The Access Total T3 assay is used for t... A recall was initiated because Beckman Coulter has identified a negative bias in test results whe... Class III Beckman Coulter Inc.
Aug 1, 2011 UniCel DxC 880i, 860i, 680i, and 660i Integrated Systems, Part Numbers: A6487... The recall was initiated because Beckman Coulter has confirmed that the UniCel Dxl and DxC Access... Class II Beckman Coulter Inc.
Aug 1, 2011 UniCel Dxl 600 Access Immunoassay System, Part Numbers: A30260, A71460, and A... The recall was initiated because Beckman Coulter has confirmed that the UniCel Dxl and DxC Access... Class II Beckman Coulter Inc.
Aug 1, 2011 UniCel Dxl 800 Access Immunoassay System, Part Numbers: 973100, A71456, and A... The recall was initiated because Beckman Coulter has confirmed that the UniCel Dxl and DxC Access... Class II Beckman Coulter Inc.
Jul 27, 2011 Access Immunoassay Systems Total T4 Calibrators, Part Number: 33805. The... A recall communication was initiated because Beckman has identified that Access Total T4 calibrat... Class II Beckman Coulter Inc.
Sep 22, 2010 ISE Electrolyte Reference reagent (for Synchron LX Systems and UniCel DxC 600... Beckman Coulter is recalling the Synchron Systems LX20/UniCel DxC ISE Reference Reagent because 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.