Medline Industries, Inc. DYNJ906893DRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10195327303372), received between May 24, 2024 and Sep 10, 2026 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Component Missing” (1 report).

4 FDA recall records name this device's identifier, 4 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. Aug 10, 2026Class IIOpen, Classified

   The kits contain neurological sponges with the potential for unexpected variability of endotoxin levels. Potentially elevated endotoxin levels may present health risks that could require medical intervention, such as neurovascular adverse events, febrile response, and/or local transient inflammation, hypotension, or nausea.

   Z-3269-2026 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

2. 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 ↗

3. 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 ↗

4. Oct 9, 2024Class IIOpen, Classified

   Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker.

   Z-0649-2025 · Root cause: Under Investigation by firm · 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 10, 2026Material Perforation; Component Missing

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50722444 ↗
• InjuryMay 24, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  ACCORDING TO THE FACILITY ON (B)(6) 2024 "THE BLADE WAS BEING USED TO CUT A NERVE AND THE SURGEON REMOVED FLICKS OF METAL FROM THE WOUND".

  Patient problems: Foreign Body In Patient

  MAUDE report 19392085 ↗