Medline DYNJP2411Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10080196745487), received between Apr 9, 2026 and Apr 13, 2026 — classified as 2 injuries.

The most frequently reported specific device problem is “Contamination” (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-1423-2026 · Root cause: Under Investigation by firm · 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 · 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.

• InjuryApr 13, 2026Contamination

  ACCORDING TO THE FACILITY ON (B)(6) 2025, "PRODUCT WAS USED AS A STERILE DRAPE FOR A BREAST AUGMENTATION PROCEDURE." THE FACILITY REPORTED, "THE PATIENT'S LEFT BREAST HAS BEEN INFECTED EVER SINCE THE SURGERY AND WILL REQUIRE AN ADDITIONAL SURGERY TO CLEAR THE INFECTION OUT."

  Patient problems: Emotional Changes; Impaired Healing; Post Operative Wound Infection

  MAUDE report 24858298 ↗
• InjuryApr 9, 2026Contamination

  ACCORDING TO THE FACILITY ON (B)(6) 2025, "PRODUCT WAS USED AS A STERILE DRAPE FOR A BREAST AUGMENTATION PROCEDURE." THE FACILITY REPORTED, "THE PATIENT'S LEFT BREAST HAS BEEN INFECTED EVER SINCE THE SURGERY AND WILL REQUIRE AN ADDITIONAL SURGERY TO CLEAR THE INFECTION OUT." THE FACILITY FURTHER REPORTED, "THERE HAS BEEN ONGOING MEDICAL CARE SINCE THE SURGERY" AS A RESULT OF "DELAYED WOUND HEALING AND NON-HEALING WITH INFECTION OF IMPLANT ON THE LEFT SIDE." THE FACILITY STATED, "THE IMPLANT WILL NEED TO BE REMOVED, THE WOUND WILL NEED TO BE CLOSED, AND THE IMPLANT REPLACED AT LATER DATE." AND "THE PATIENT HAS SUFFERED INJURY TO HER BREAST DURING THE INFECTION." PATIENT IS "FRUSTRATED AND ANGRY." PER THE FACILITY "THE DRAPE WAS USED AND DISCARDED."

  Patient problems: Emotional Changes; Impaired Healing; Post Operative Wound Infection

  MAUDE report 24833226 ↗