Nellcor EASYCAP II 6Recalls & reported problems
Covidien LP · Adult Colorimetric CO2 Detector · Class 2
All models of Nellcor (64)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10884521709829), received between Mar 17, 2022 and Mar 17, 2022 — classified as 1 malfunction.
The most frequently reported specific device problem is “Device Ingredient or Reagent Problem” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Device Ingredient or Reagent Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 17, 2022Device Ingredient or Reagent Problem; Device Ingredient or Reagent Problem
ACCORDING TO THE REPORTER, THE DEVICE'S COLOR DID NOT CHANGE EVEN IT WAS USED ON THE PATIENT. THE PATIENT WAS FIRMLY INTUBATED WHEN CHECKED VIA X-RAY. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13793328 ↗
Other ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE devices
- Alaris 8300Carefusion 303, Inc. · ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE1 recall2 deaths8,444 reports
- Alaris 8300Carefusion 303, Inc. · ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE1 recall607 reports
- BD Alaris™ ETCO2 Module, Model 8300Carefusion 303, Inc. · ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE485 reports
- BD Alaris™ ETCO2 Module, Model 8300Carefusion 303, Inc. · ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE471 reports
- NA GF-210RNihon Kohden Corporation · ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE386 reports
- Trilogy IT2110X21BRespironics, Inc. · ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE5 recalls30 reports
- Trilogy Trilogy Evo Ventilator, GermanyRespironics, Inc. · ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE5 recalls26 reports
- Trilogy Evo Trilogy Evo Ventilator with oxygen blending model, GermanyRespironics, Inc. · ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE5 recalls9 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page