PremierPro 8326BRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00818566010193), received between Sep 25, 2023 and May 6, 2026 — classified as 3 malfunctions.

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 6, 2026

  THE STERILE OR TOWELS FROM PREMIERPRO ARE HAVING AN ISSUE WITH EXTRA LINT THAT IS TRANSFERRING TO WIRES WHEN WET. LOTS OF LINT COMING OFF TOWELS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25092856 ↗
• MalfunctionApr 30, 2024

  FOREIGN OBJECT IN STERILE PACKAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19212480 ↗
• MalfunctionSep 25, 2023

  WHEN OPENING A PACK OF STERILE SINGLE USE TOWELS, DEBRIS OF UNKNOWN ORIGIN, SIMILAR TO HAIR, WAS FOUND IN THE WEAVE OF THE TOWEL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17806928 ↗