BluPRO® TL-271T3Recalls & reported problems
Nihon Kohden Corporation · SpO2 probe Adults (30 kg or more) Finger or toe, disposable · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 14931921878535), received between Dec 6, 2024 and Dec 6, 2024 — classified as 1 injury.
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.
Reports received per month
Most reported problems
Device problems
- Appropriate Device Problem Term/Code Not Available1
Patient problems
- Swelling/ Edema1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryDec 6, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
THE CUSTOMER REPORTED THAT THE PATIENT WAS WINCING IN PAIN AND GUARDING THE FINGER WITH THE PULSE OXIMETER PROBE ON IT. UPON REMOVAL OF THE DEVICE, THERE WAS A BLISTER WHERE THE DEVICE HAD BEEN, AND THE FINGER WAS WARM AND RED WITH SLIGHT EDEMA.
Patient problems: Swelling/ Edema
MAUDE report 20865518 ↗
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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.
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