Medline Industries, Inc. DYNJ66039BRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10195327151997), received between Mar 22, 2024 and Apr 8, 2024 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (2 reports).

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. Mar 3, 2025Class IIOpen, Classified

   There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.

   Z-1597-2025 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

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.

• MalfunctionApr 8, 2024Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT AN EAR ULCER SYRINGE COMPONENT "EXPLODED" DURING USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19057204 ↗
• MalfunctionMar 26, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT AN EAR ULCER SYRINGE COMPONENT BROKE DURING USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18978289 ↗
• MalfunctionMar 22, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT AN EAR ULCER SYRINGE COMPONENT WAS "DEFECTIVE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18958520 ↗