Medline Industries, Inc. DYNJ83961ARecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10195327517748), received between Sep 18, 2025 and Oct 27, 2025 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Break” (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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Mar 3, 2025Open, Classified

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

   Z-1591-2025 · Root cause: Under Investigation by firm · 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.

• MalfunctionOct 27, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A SYRINGE BROKE DURING USE. THE CONTENTS EJECTED AND LANDED IN MULTIPLE INDIVIDUALS' EYES.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 23391321 ↗
• MalfunctionSep 18, 2025Break; Crack; Break; Crack

  IT WAS REPORTED THAT 20 ML "SYRINGES ARE FAULTY AND BURST/CRACK ALONG THE SIDE OF THE BARREL" WITHOUT "EXCESSIVE PRESSURE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23088598 ↗
• MalfunctionSep 18, 2025Break; Crack; Break; Crack

  IT WAS REPORTED THAT 10 ML "SYRINGES ARE FAULTY AND BURST/CRACK ALONG THE SIDE OF THE BARREL" WITHOUT "EXCESSIVE PRESSURE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23086254 ↗