Merge Healthcare recalls

Merge Healthcare has 96 recalls on record with the FDA and USDA, the earliest in 2014 and the latest reported on 2 Sep 2026. 9 are still ongoing. 3 were reported in the last 12 months. The most frequent reason is device malfunction.

Total recalls96since 2014
Last 12 months3reported
Class I00% of total
Ongoing9latest 2 Sep 2026

Recalls per month, last 24 months

click a bar for that month

Severity split

Class I 0 0%Class II 96 100%Class III 0 0%

By year

Ongoing merge healthcare recalls

9 active

All merge healthcare recalls, newest first

96 total
ReportedClassRecallCompanyReasonWhere
DeviceCLASS IIMerge PACS and Merge OrthoPACS recalled by Merge HealthcareMerge HealthcareLabeling ErrorsNationwide
DeviceCLASS IIMerge OrthoPACS, medical imaging diagnostic workstation recalledMerge HealthcareOtherNationwide
DeviceCLASS IIMerge PACS, medical imaging diagnostic workstation recalledMerge HealthcareOtherNationwide
DeviceCLASS IIThe Merge Hemo recalled by Merge HealthcareMerge HealthcareDevice MalfunctionNationwide
DeviceCLASS IIVericis, Merge Cardio recalled by Merge HealthcareMerge HealthcareDevice MalfunctionWI
DeviceCLASS IIVericis, Merge Cardio recalled by Merge HealthcareMerge HealthcareDevice MalfunctionWI
DeviceCLASS IIMerge Cardio recalled by Merge HealthcareMerge HealthcareDevice MalfunctionWI
DeviceCLASS IIVericis, Merge Cardio recalled by Merge HealthcareMerge HealthcareDevice MalfunctionWI
DeviceCLASS IIVericis, Merge Cardio recalled by Merge HealthcareMerge HealthcareDevice MalfunctionWI
DeviceCLASS IIMerge Hemo recalled by Merge HealthcareMerge HealthcareDevice MalfunctionWI
DeviceCLASS IIMerge LIS recalled by Merge HealthcareMerge HealthcareDevice Malfunction15 states
DeviceCLASS IIMerge PACS recalled by Merge HealthcareMerge HealthcareOther25 states
DeviceCLASS IIMerge Application Server recalled by Merge HealthcareMerge HealthcareLabeling ErrorsNationwide
DeviceCLASS IIMerge PACS versions 7.3, 7.3.1 recalled by Merge HealthcareMerge HealthcareDevice MalfunctionNationwide
DeviceCLASS IIMerge OrthoPACS versions 7.3, 7.3.1 recalled by Merge HealthcareMerge HealthcareDevice MalfunctionNationwide
DeviceCLASS IIThe WinStation Retinal Imager, also known as Merge Eye Station recalledMerge HealthcarePackaging DefectsNationwide
DeviceCLASS IIMerge Unity recalled by Merge HealthcareMerge HealthcareDevice MalfunctionNationwide
DeviceCLASS IIFellows "Mighty 8" Power strip recalled by Merge HealthcareMerge HealthcareOtherNationwide
DeviceCLASS IIMerge Unity recalled by Merge HealthcareMerge HealthcareDevice MalfunctionNationwide
DeviceCLASS IIMerge Eye Care Pacs Viewer 5.2 Merge Eye Care Pacs recalledMerge HealthcareDevice Malfunction9 states
DeviceCLASS IIThe Schiller PB 1000, also known as Merge Hemo Patient Data recalledMerge HealthcareDevice MalfunctionNationwide
DeviceCLASS IIMerge LIS recalled by Merge HealthcareMerge HealthcareDevice MalfunctionNationwide
DeviceCLASS IIMasimoSET LNOP DCI adult SpO2 reusable sensor recalledMerge HealthcareTemperature AbuseNationwide
DeviceCLASS IIMasimoSET Lnop Dcip pediatric/slender digit SpO2 reusable recalledMerge HealthcareTemperature AbuseNationwide
DeviceCLASS IISpO2 connecting cable for Masimo LNCS sensor (Merge recalledMerge HealthcareTemperature AbuseNationwide
DeviceCLASS IIMasimo SPO2 Sensor, ear clip-adult (Merge recalled by Merge HealthcareMerge HealthcareTemperature AbuseNationwide
DeviceCLASS IIMerge OrthoPACS recalled by Merge HealthcareMerge HealthcareDevice MalfunctionNationwide
DeviceCLASS IIMerge OrthoPACS recalled by Merge HealthcareMerge HealthcareDevice MalfunctionNationwide
DeviceCLASS IIMerge PACS recalled by Merge HealthcareMerge HealthcareDevice MalfunctionNationwide
DeviceCLASS IIMerge PACS recalled by Merge HealthcareMerge HealthcareDevice MalfunctionNationwide

About this list

Records come from FDA enforcement reports and USDA FSIS notices, grouped by normalised name. A company operating under several names may appear more than once.