Medline Industries, Inc. DYNJ64882DRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10195327551568), received between Mar 25, 2024 and Mar 25, 2024 — classified as 1 injury.

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

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.

• InjuryMar 25, 2024Material Puncture/Hole; Material Puncture/Hole

  ACCORDING TO THE CUSTOMER, ON (B)(6) 2024 WHEN THE NEEDLE WAS RECAPPED IT "POKED THROUGH THE CAP" AND WHEN THE NEEDLE WAS BEING "UNSCREWED" THE SCRUB TECH WAS "POKED".

  Patient problems: Exposure to Body Fluids

  MAUDE report 18975701 ↗