Medline Industries, Inc. DYNJ84928Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10195327437725), received between Jan 26, 2024 and Jan 26, 2024 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Integrity Problem” (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 19, 2026Class IIOpen, Classified

   During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-of-specification for endotoxin.

   Z-2038-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

2. 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.

• MalfunctionJan 26, 2024Material Integrity Problem; Material Integrity Problem

  "THE RADIOPAQUE THREAD IN THE GAUZE WHERE LOOSE AND CAME OUT".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18589417 ↗