Medline Industries, Inc. VAL009CATEARecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10889942872398), received between Apr 30, 2021 and Apr 30, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Contamination” (1 report).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Sep 4, 2024Class IIOpen, Classified

   It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile product if the vendor seal of the pouch is opened/unsealed.

   Z-0178-2025 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

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 30, 2021Contamination

  IT WAS REPORTED, "BLUE FIBERS IN THE CUSTOM PACK ARE EVIDENT ON THE INSTRUMENTS WITHIN THE PACK. FIBERS HAVE BEEN FOUND IN THE EYE AS WELL." SPECIFICALLY MENTIONED, "IT WAS INSIDE THE EYE, ON TOP OF THE LENS AND WAS REMOVED WITH UTRADA FORCEPS, 3/17/21 BY MD."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11752484 ↗