Medline DYNJP8002Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10080196740796), received between Sep 4, 2026 and Sep 16, 2026 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (2 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. How this data works · Data updated Oct 13, 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-2128-2026 · Root cause: Process control · 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-1423-2026 · Root cause: Under Investigation by firm · 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 16, 2026Material Split, Cut or Torn

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50794940 ↗
• MalfunctionSep 4, 2026Material Puncture/Hole; Material Split, Cut or Torn

  It was reported that ¿The white is the top of the velcro and the purple is the bottom of the velcro. When they pulled the top of the white velcro the purple strip created the hole.¿

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50614986 ↗