Medline DYNJP8201Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10080196740765), received between Jan 30, 2026 and Sep 9, 2026 — classified as 2 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (6 reports).

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 16, 2026.

Recalls naming this device

1. Jan 7, 2026Open, Classified

   Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.

   Z-1423-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

2. Jan 7, 2026Open, Classified

   Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.

   Z-2128-2026 · Root cause: Process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 9, 2026Material Split, Cut or Torn

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50696388 ↗
• MalfunctionSep 8, 2026Material Split, Cut or Torn

  It was reported that "we have had 3 hip drapes over the last week or so that the pocket part where they drop the leg down into has ripped and contaminates the leg."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50672598 ↗
• MalfunctionSep 3, 2026Material Split, Cut or Torn

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50594467 ↗
• MalfunctionSep 2, 2026Material Split, Cut or Torn

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50573775 ↗
• InjuryFeb 4, 2026Material Split, Cut or Torn

  ACCORDING TO THE FACILITY ON (B)(6) 2025, A SURGICAL SITE INFECTION OCCURRED IN A PATIENT WHO UNDERWENT A TOTAL HIP REPLACEMENT. THE FACILITY REPORTED THAT THE DRAPE MODEL TORE DURING THE DRAPING PROCESS ON MULTIPLE OCCASIONS, LEADING SURGEONS TO REFUSE CONTINUED USE OF THE PRODUCT. WOUND CULTURES WERE OBTAINED AND THE PATIENT REQUIRED RETURN TO SURGERY FOR INCISION/DRAINAGE OF THE AFFECTED HIP. AT THE TIME OF THE REPORT, THE PATIENT REMAINED IN THE RECOVERY PERIOD AND CONTINUED TO FOLLOW UP WITH THE SURGEON.

  Patient problems: Post Operative Wound Infection

  MAUDE report 24260771 ↗
• InjuryJan 30, 2026Material Split, Cut or Torn

  ACCORDING TO THE CUSTOMER, A "SURGICAL SITE INFECTION" WAS REPORTED FOLLOWING A TOTAL HIP REPLACEMENT ON (B)(6) 2025 WHERE THE DRAPES TORE DURING THE PROCEDURE. THE CUSTOMER REPORTED THAT THE PATIENT WAS "TAKEN BACK TO SURGERY FOR INCISION & DRAINAGE" OF THE AFFECTED HIP WHERE "WOUND CULTURES" WERE TAKEN.

  Patient problems: Unspecified Infection

  MAUDE report 24223639 ↗