Medline DYNJP3102ARecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10080196778362), received between Sep 19, 2025 and Sep 12, 2026 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Component Missing” (1 report).

3 FDA recall records name this device's identifier, 3 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 ↗

3. Feb 13, 2025Open, Classified

   Potential breach in pouch packaging which could lead to loss of sterility.

   Z-1363-2025 · Root cause: Packaging process control · 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 12, 2026Component Missing

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50745061 ↗
• InjurySep 19, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  ACCORDING TO THE CUSTOMER, THE VELCRO FROM THE DRAPE "BECAME DETACHED AND ADHERED TO THE PATIENT'S BOWEL" ON (B)(6) 2025 AND EXTENDED THE LENGTH OF THE PROCEDURE IN ORDER TO "REMOVE SAFELY".

  Patient problems: Foreign Body In Patient

  MAUDE report 23097425 ↗