Medline DYNJP2001SRecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10080196304660), received between Apr 7, 2021 and Sep 17, 2026 — classified as 2 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Material Integrity Problem” (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. 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

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 17, 2026Device Contaminated During Manufacture or Shipping

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50810340 ↗
• MalfunctionSep 14, 2026Material Integrity Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50762991 ↗
• MalfunctionSep 8, 2026Material Integrity Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50674947 ↗
• MalfunctionSep 1, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50541854 ↗
• MalfunctionJun 12, 2026Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE GOWN FAILED TO PROTECT SCRUB NURSE FROM BLOOD EXPOSURE. A SMALL AMOUNT OF BLOOD WAS SPLASHED ONTO THE SLEEVE AND SOAKED THROUGH THE GOWN ON TO THE SKIN OF THE SCRUB NURSE.

  Patient problems: Insufficient Information

  MAUDE report 25492819 ↗
• InjuryFeb 12, 2026Appropriate Device Problem Term/Code Not Available

  ACCORDING TO THE CUSTOMER, THREE GOWNS INCLUDED IN A LATER RECALL WERE USED DURING A "TOTAL KNEE ARTHROPLASTY" PROCEDURE ON (B)(6) 2026. THE CUSTOMER REPORTED THAT THE PATIENT DEVELOPED AN "INFECTED KNEE[S] AND REQUIRED A SECOND SURGERY ON (B)(6) 2026."

  Patient problems: Post Operative Wound Infection

  MAUDE report 24327958 ↗
• InjuryFeb 12, 2026Appropriate Device Problem Term/Code Not Available

  ACCORDING TO THE CUSTOMER, THREE GOWNS INCLUDED IN A LATER RECALL WERE USED DURING A "TOTAL KNEE ARTHROPLASTY" PROCEDURE ON (B)(6) 2026. THE CUSTOMER REPORTED THAT THE PATIENT DEVELOPED AN "INFECTED KNEE[S] AND REQUIRED A SECOND SURGERY ON (B)(6) 2026."

  Patient problems: Post Operative Wound Infection

  MAUDE report 24327383 ↗
• MalfunctionJun 7, 2021Material Fragmentation

  IT WAS REPORTED THAT SURGICAL GOWN MATERIAL WAS COMING OFF THE PRODUCT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11946902 ↗
• MalfunctionApr 7, 2021Contamination; Material Frayed

  IT WAS REPORTED, A PHYSICIAN AND TECHNICIAN WERE REMOVING STERILE SURGICAL GOWN "STRANDS AS LONG AS 2-3 CENTIMETERS THAT HAD MADE ITS WAY TO IMPLANTS, INSTRUMENTS, AND EVEN INSIDE THE BRAIN."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11631047 ↗