Rapr-Round 8001-061-550Recalls & reported problems
Stryker Corporation · Class 2
Data updated Oct 18, 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 07613327175158), received between Jan 7, 2026 and Jan 7, 2026 — classified as 1 malfunction.
The most frequently reported specific device problem is “Fluid/Blood Leak” (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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Fluid/Blood Leak1
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.
MalfunctionJan 7, 2026Fluid/Blood Leak
IT WAS REPORTED THAT THERE WERE SIGNIFICANT LEAKS IN THE CONNECTORS DURING CONNECTION. WHEN PLUGGING IN THE WARMER SET, THE LEAK OCCURRED AS SOON AS IT WAS CONNECTED. NO DEFECTS VISIBLE TO THE NAKED EYE. THE USERS' BEDS WERE HEAVILY WET. A COMPLETE REPLACEMENT OF THE BEDDING HAD TO BE CARRIED OUT FOR UNSTABLE PATIENTS HOSPITALIZED IN INTENSIVE CARE. NO EFFECT ON PATIENT HEALTH WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23990315 ↗
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- HotDog Temperature Management System WC77Augustine Temperature Management LLC · System, Thermal Regulating2 recalls0 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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