Norm-O-Temp® 111ZRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10613031861549), received between Apr 19, 2022 and Mar 14, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (1 report).

1 FDA recall record name this device's identifier.

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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Jun 20, 2019Terminated

   The manual does not provide instruction stating that exceeding 40 Celsius for extended periods can cause tissue damage.

   Z-2355-2019 · Root cause: Labeling False and Misleading · FDA record ↗

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 14, 2025Leak/Splash; Leak/Splash

  CUSTOMER REPORTS THAT THIS DEVICE HAS A LEAK. ADDITIONAL INFORMATION: DURING THE SERVICE EVALUATION, IT WAS OBSERVED THAT THERE WAS A HOLE IN THE RESERVOIR DUE TO THERMAL DECOMPOSITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21605093 ↗
• MalfunctionApr 19, 2022Overheating of Device; Improper or Incorrect Procedure or Method

  THE CUSTOMER STATES THAT THE UNIT OVERHEATED. THE UNIT WAS IN THE OPERATING ROOM, PREPPING FOR A PAITENT BUT WAS NEVER USED FOR THE PAITENT. THE UNIT WAS LEFT ON AND RUNNING OVERNIGHT WITHOUT OVERSIGHT. THE CUSTOMER NOTICED THAT THE UNIT HAD CAUSED DAMAGE TO ITSELF AND TO OBJECTS AROUND THE DEVICE. THE CUSTOMER CLAIMS THAT THEY DID NOT DISCOVER THE UNIT MALFUNCTION UNTIL THE NEXT DAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14141356 ↗