AMSure® Bulb Irrigation Syringe 1Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10704411008460), received between Apr 1, 2019 and Apr 1, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Delivered as Unsterile Product” (1 report).

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 18, 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.

• MalfunctionApr 1, 2019Delivered as Unsterile Product

  WHILE OPENING ITEMS ONTO THE STERILE FIELD, THE SCRUB TECHNICIAN NOTICED A STRANGE SUBSTANCE INSIDE OF A STERILE PEEL PACKED BULB SYRINGE ON THE BULB BEFORE IT CAME INTO CONTACT WITH THE FIELD. IT WAS TAKEN OUT OF THE ROOM AND REPORTED. REF: AS011P; LOT: 129578KS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8468833 ↗