CooperSurgical recalls

CooperSurgical has 86 recalls on record with the FDA and USDA, the earliest in 2014 and the latest reported on 30 Sep 2026. 36 are still ongoing. 2 were reported in the last 12 months.

Total recalls86since 2014
Last 12 months2reported
Class I33% of total
Ongoing36latest 30 Sep 2026

Recalls per month, last 24 months

click a bar for that month

Severity split

Class I 3 3%Class II 73 85%Class III 10 12%

By year

Ongoing coopersurgical recalls

36 active

All coopersurgical recalls, newest first

86 total
ReportedClassRecallCompanyReasonWhere
DeviceCLASS IInca (Infant Nasal Cannulae Assy) Infant Nasal CPAP, Complete Set recalledCooperSurgicalOtherNationwide
DeviceCLASS IInca (Infant Nasal Cannulae Assy) Neonatal Nasal CPAP recalledCooperSurgicalOtherNationwide
DeviceCLASS IIHSG Procedure Tray recalled by CooperSurgicalCooperSurgicalSterilityNationwide
DeviceCLASS IIEndosee System Convenience Kit recalled by CooperSurgicalCooperSurgicalSterilityNationwide
DeviceCLASS IIEndosee System Convenience Kit with IV Tube recalled by CooperSurgicalCooperSurgicalSterilityNationwide
DeviceCLASS IIK-Systems R65 Trolley recalled by CooperSurgicalCooperSurgicalTemperature Abuse14 states
DeviceCLASS IIK-Systems T47 Warming Plate recalled by CooperSurgicalCooperSurgicalTemperature Abuse14 states
DeviceCLASS IIK-Systems G73 Dry Bath Incubator recalled by CooperSurgicalCooperSurgicalTemperature Abuse14 states
DeviceCLASS IIK-Systems Multiple/unknown recalled by CooperSurgicalCooperSurgicalTemperature Abuse14 states
DeviceCLASS IIK-Systems T47 Warming Plate recalled by CooperSurgicalCooperSurgicalTemperature Abuse14 states
DeviceCLASS IIK-Systems G85 Mini Incubator recalled by CooperSurgicalCooperSurgicalTemperature Abuse14 states
DeviceCLASS IISilver-Plated Copper Sims Uterine Sound recalled by CooperSurgicalCooperSurgicalOtherNationwide
DeviceCLASS IIOrigio Sperm Wash Medium Pack of Five bottles - Intended recalledCooperSurgicalOtherNationwide
DeviceCLASS IIOrigio Sperm Wash Medium Pack of Ten bottles - Intended recalledCooperSurgicalOtherNationwide
DeviceCLASS IIOrigio Sperm Wash Medium Pack of Five bottles - Intended recalledCooperSurgicalOtherNationwide
DeviceCLASS IIStainless Steel Sims Uterine Sound recalled by CooperSurgicalCooperSurgicalForeign MaterialNationwide
DeviceCLASS IIglobal Medium recalled by CooperSurgicalCooperSurgicalOtherNationwide
DeviceCLASS IIBox as labeled: Regard, Carter-Thomason CloseSure System XL recalledCooperSurgicalOtherNationwide
DeviceCLASS IIH/S Catheter SET FR 5 with Integated Stylet recalled by CooperSurgicalCooperSurgicalPackaging DefectsNationwide
DeviceCLASS IICooper Surgical H/S Elliptosphere Cath Set recalledCooperSurgicalPackaging DefectsNationwide
DeviceCLASS IICooper Surgical H/S Elliptosphere Cath -For administering recalledCooperSurgicalPackaging DefectsNationwide
DeviceCLASS IIGlobal Total LP single step medium recalled by CooperSurgicalCooperSurgicalDevice MalfunctionNationwide
DeviceCLASS IIBiopsy Medium, Reference Number 10620010 A, used recalledCooperSurgicalPotency & AssayGA
DeviceCLASS IINEO-fit Neonatal Endotracheal Tube Grip recalled by CooperSurgicalCooperSurgicalForeign MaterialNationwide
DeviceCLASS IIHumidifier bottle and syringe filter kit of each) recalledCooperSurgicalSterility21 states
DeviceCLASS IIHumidifier bottle and syringe filter kit of each) recalledCooperSurgicalSterility21 states
DeviceCLASS IILifeGlobal Fast Freeze Thawing Kit recalled by CooperSurgicalCooperSurgicalTemperature Abuse31 states
DeviceCLASS IIVitriguard, Carrier, Clear recalled by CooperSurgicalCooperSurgicalSterility10 states
DrugCLASS IParagard T380A (intrauterine copper contraceptive) recalledCooperSurgicalSterilityNationwide
DeviceCLASS IILeep Precision Generator 120V Cooper Surgical recalledCooperSurgicalDevice 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.