BioShield 00711133 (UDI 00724995183554)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00724995183554), received between Jul 18, 2024 and Jul 18, 2024 — classified as 1 malfunction.

The most frequently reported specific device problem is “Leak/Splash” (1 report).

1 other recall cover devices cleared under the same FDA submission (K070420, K210342, K232951); 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.

• MalfunctionJul 18, 2024Leak/Splash; Leak/Splash

  THE USER FACILITY REPORTED THAT THERE WAS BILE BACKFLOW WHILE USING THEIR BIOSHIELD IRRIGATOR. NO REPORT OF INJURY OR PROCEDURE DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19773469 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K070420, K210342, K232951. One submission often covers many models, so check the product and lot details in each record.

• Z-0861-2015 · Oct 31, 2014 · Terminated
  UroSeal Adjustable Endoscopic Valve. Model/Catalog # 00913410 The primary packaging is a Tyvek pouch. The secondary package is a corrugate box. 5 units per box. Used to cover t