BioShield 00711125 (UDI 10724995183490)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10724995183490), received between Jun 5, 2020 and Apr 3, 2024 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

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.

• MalfunctionApr 3, 2024Leak/Splash; Leak/Splash

  THE USER FACILITY REPORTED THAT DURING A PATIENT PROCEDURE, SPRAY FROM THE BIOSHIELD BIOPSY VALVE MADE CONTACT WITH THE PHYSICIAN. NO HARM TO PATIENT OR USERS WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19033338 ↗
• MalfunctionJun 5, 2020Fluid/Blood Leak

  THE DISTRIBUTOR REPORTED THAT DURING USAGE OF THE BIOSHIELD BIOPSY VALVE ON A BRONCHOSCOPE, FLUID PROJECTED FROM THE CAP WHEN INJECTING SALINE. NO HARM TO PATIENT OR USERS WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10125310 ↗

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