BluPRO® TL-631T3Recalls & reported problems
Nihon Kohden Corporation · Finger probe Adult, child (20 kg or more) Finger or toe · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04931921877494), received between Sep 19, 2025 and Jul 21, 2026 — classified as 4 injuries.
The most frequently reported specific device problem is “Electrical /Electronic Property Problem” (4 reports).
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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Electrical /Electronic Property Problem4
Patient problems
- No Clinical Signs, Symptoms or Conditions4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryJul 21, 2026Electrical /Electronic Property Problem
THE CUSTOMER REPORTED THAT THE PSG NK RME ADULT SPO2 FINGERTIP PROBE, CAUSED VISIBLE BURNS TO A PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25888339 ↗InjurySep 19, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem
THE CUSTOMER REPORTED THAT THREE OF THEIR TL-0631T3 PROBES STOPPED WORKING. ACCORDING TO THE CUSTOMER, THE PATIENT HAD A CONTACT PRESSURE SORE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23100052 ↗InjurySep 19, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem
THE CUSTOMER REPORTED THAT THREE OF THEIR (B)(4) PROBES STOPPED WORKING. ACCORDING TO THE CUSTOMER, THE PATIENT HAD A CONTACT PRESSURE SORE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23099777 ↗InjurySep 19, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem
THE CUSTOMER REPORTED THAT THREE OF THEIR TL-0631T3 PROBES STOPPED WORKING. ACCORDING TO THE CUSTOMER, THE PATIENT HAD A CONTACT PRESSURE SORE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23099428 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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