Medline Industries, Inc. DYNJ67162Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10193489395969), received between Mar 12, 2021 and Mar 12, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Fragmentation” (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. Nov 21, 2024Class IIOpen, Classified

   Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties & Surgical Strips, which have the potential for endotoxin contamination.

   Z-0794-2025 · Root cause: Nonconforming Material/Component · 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.

• MalfunctionMar 12, 2021Material Fragmentation

  IT WAS REPORTED THAT THE X-RAY DETECTABLE GAUZE WAS SHEDDING GAUZE MATERIAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11474017 ↗