Tuttnauer® WTL198-0079Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07798164677468), received between Jan 9, 2024 and Jan 9, 2024 — classified as 1 malfunction.

2 other recalls cover devices cleared under the same FDA submission (K163646); they may or may not involve this specific model.

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.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 9, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE INCUBATOR LIGHTS WERE TURNING ON AND OF AND IT WAS BEEPING. IT COULD NOT BE USE FOR INCUBATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18477795 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K163646. One submission often covers many models, so check the product and lot details in each record.

• Z-1248-2025 · Jan 15, 2025 · Open, Classified
  ASP BIOTRACE Auto Read 60 Steam BI Process Challenge Device, REF 73135.
• Z-0837-2024 · Dec 7, 2023 · Open, Classified
  Terragene Bionova PCD (PCD222-C)