Medline DYNJP4104Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10080196825479), received between Sep 9, 2026 and Sep 23, 2026 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (3 reports).

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• OtherSep 23, 2026Physical Resistance/Sticking

  It was reported that the drape was "Very difficult to open and drape over the patient" and "very \"sticky\" to open up and not easily drapeable."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50872308 ↗
• MalfunctionSep 15, 2026Physical Resistance/Sticking

  It was reported that "With one motion the first 1/2 of the drape is opened, with some adherence of the plastic drape" and "The adherence causes the previously opened portion to shift/move and change the location of the sterile field". It was reported that "This renders the sterile drape technically unsterile as the portion of the drape that falls below the sterile plane has shifted up due to the adherence".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50772520 ↗
• MalfunctionSep 15, 2026Material Fragmentation

  It was reported that when the drap gets saturated, the surgeon is noticing that the fibers from the drape are coming off to the surgeons gloves and even the dye from the drape is coming to the gloves.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50766438 ↗
• MalfunctionSep 9, 2026Physical Resistance/Sticking

  It was reported that the barrier/film side of the drape is significantly stickier than normal production. When draping in the sterile field, it prevents sterile practice when unfolding the drape and has caused some instances of compromising sterility, having to break down and reset the field.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50691147 ↗