Medline Industries, Inc. DYNJS0302Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10080196798711), received between Sep 14, 2026 and Sep 14, 2026 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Material Puncture/Hole” (1 report).

2 FDA recall records name this device's identifier, 2 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-1598-2025 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

2. Nov 17, 2022Class IIOpen, Classified

   Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.

   Z-1074-2023 · Root cause: Device Design · Recall details · FDA record ↗

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.

• MalfunctionSep 14, 2026Material Puncture/Hole

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50762591 ↗
• MalfunctionSep 14, 2026Unsealed Device Packaging

  It was reported that "1 pack not sealed prior to sterilization".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50752077 ↗