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Medline DYNJP2307PRecalls & reported problems

Medline Industries, Inc. · GOWN,PREVENTION PLUS,XL,ST,24/CS · Class 2

Data updated Oct 16, 2026 from official FDA records · Editorial policy

2 open recalls name this device. See the recall details and contact the manufacturer or your healthcare provider.

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
2

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10080196290765), received between May 23, 2018 and May 23, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (1 report).

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-2129-2026 · Root cause: Process control · 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-1424-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Device problems

  • Device Contamination with Chemical or Other Material1

Patient problems

  • No Consequences Or Impact To Patient1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionMay 23, 2018Device Contamination with Chemical or Other Material

    WHEN OPENING A STERILE SURGICAL GOWN, A WOODEN STICK WAS FOUND IN THE PACKAGING; BEFORE IT WAS OPENED ONTO THE STERILE FIELD. NO PATIENT HARM. NO DELAY TO PROCEDURE.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 7536829 ↗

Other GOWN, SURGICAL devices

All GOWN, SURGICAL devices →

Sources and updates

How reports and recalls are matched · Editorial policy · Report an error on this page