cap-ONERecalls & reported problems across all models
Nihon Kohden Corporation · 3 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names at least one cap-ONE model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls
- 1
We found 3 models of cap-ONE by Nihon Kohden Corporation in the FDA's device registry (GUDID). Together they are named in 3 adverse event reports in the FDA's MAUDE database, received between Jul 28, 2021 and May 28, 2024 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Output Problem” (2 reports).
1 FDA recall record name at least one of these models by its device identifier, 1 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
cap-ONE recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Apr 29, 2022Open, Classified
Due to products being shipped/distributed to customers after the products expiration date had past.
Z-0314-2025 · Root cause: Process control · Recall details · FDA record ↗
Most reported cap-ONE problems
Device problems
- Output Problem2
- Incorrect, Inadequate or Imprecise Result or Readings1
- Non Reproducible Results1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
cap-ONE models
3 models, most reported first. Each model has its own page with its reports, recalls and device details.
- cap-ONE YG-227TEndoscopic bite block1 recall0 reports
- cap-ONE TG-970PANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE2 reports
- cap-ONE TG-920PANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE1 report
Recent cap-ONE adverse event reports
The 3 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionMay 28, 2024Incorrect, Inadequate or Imprecise Result or Readings; Non Reproducible Results; Incorrect, Inadequate or Imprecise Result or Readings; Non Reproducible Results
THE BIOMEDICAL ENGINEER (BME) RECEIVED A REPORT FROM THE NURSES THAT THIS ETCO2 SENSOR WAS READING INTERMITTENTLY WHILE IN PATIENT USE. NO PATIENT HARM WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19404158 ↗MalfunctionJul 28, 2021Output Problem; Output Problem
THE SLEEP, EEG, EVS MANAGER REPORTED THAT THEY NOTICED THE HIGH VALUES AND WENT TO CHECK ON THE PATIENT. THEY THEN DECIDED TO CHECK OTHER CABLES AND FOUND THAT THIS TG-970P, CO2 SENSOR KIT, WAS GIVING INACCURATE READING. NO PATIENT HARM WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12243016 ↗MalfunctionJul 28, 2021Output Problem; Output Problem
THE SLEEP, EEG, EVS MANAGER REPORTED THAT THEY NOTICED HIGH VALUES AND WENT TO CHECK ON THE PATIENT. THEY THEN DECIDED TO CHECK OTHER CABLES AND FOUND THAT THIS TG-970P, CO2 SENSOR KIT, WAS GIVING INACCURATE READINGS. NO PATIENT HARM WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12242980 ↗
Other Nihon Kohden Corporation products
All Nihon Kohden Corporation devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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.
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