Medline Industries, Inc. DYNJ33656FRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10198459135385), received between Jan 17, 2025 and Sep 9, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Contamination /Decontamination Problem” (1 report).

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.

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 9, 2025Contamination /Decontamination Problem

  UPON OPENING SURGICAL PACK "[REDACTED] HEAD & NECK PACK", THE CST [CERTIFIED SURGICAL TECHNOLOGIST] NOTICED A BROWN FOREIGN OBJECT IN THE STACK OF RAYTECS "4X4 XRAY GAUZE". CST IDENTIFIED OBJECT AS POTENTIALLY UNSTERILE, AND PACK CONTAMINATED. CST REMOVED THE PACK FROM OR AS WELL AS ALL OPENED ITEMS, THEN USED A NEW PACK AND SUPPLIES. PATIENT WAS NOT IN THE ROOM AT TIME OF OPENING CONTAMINATED PACK. AFTER NEW PACK AND ITEMS WERE OPENED, CASE COMPLETED WITHOUT ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23003783 ↗
• MalfunctionJan 17, 2025

  WHEN PREPPING FOR A CASE, SCRUB TACK OPENED MEDLINE HEAD & NECK PACK AND FOUND FOREIGN OBJECT (MATERIAL) INSIDE THE RAY-TEC SPONGE COMPROMISING ENTIRE PACK. SPONGE WAS SAVED IN BIOHAZARD BAG AND THE REST OF THE PACK WAS DISPOSED OF. PATIENT WAS NOT IN THE ROOM YET.NEW PACK WAS OPENED AND CASE PREPPING CONTINUED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21178170 ↗