Medline DYND10160Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10080196997091), received between Feb 25, 2026 and Mar 2, 2026 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Air/Gas in Device” (3 reports).

1 FDA recall record name this device's identifier, 1 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. May 25, 2022Open, Classified

   Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21.

   Z-1609-2022 · Root cause: Environmental control · FDA record ↗

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 2, 2026Fluid/Blood Leak; Component Missing; Device Misassembled During Manufacturing /Shipping; Air/Gas in Device

  ACCORDING TO THE FACILITY, ON (B)(6) 2026, A CATHETER CHANGE KIT WAS OPENED AND IT WAS NOTED THAT THE BLACK CAP WAS NOT PRESENT ON THE SYRINGE AND THERE WAS A LARGE AMOUNT OF AIR IN THE SYRINGE, WATER LOSS AND PLUNGER QUITE LOW.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24484789 ↗
• MalfunctionFeb 26, 2026Component Missing; Air/Gas in Device

  ACCORDING TO THE FACILITY, A CATHETER CHANGE KIT WAS OPENED AND IT WAS NOTED THAT THE BLACK CAP WAS NOT PRESENT ON THE SYRINGE AND THERE WAS A LARGE AMOUNT OF AIR IN THE SYRINGE. THE FACILITY REPORTED THAT THE KIT WAS NOT USED. THE FACILITY FURTHER REPORTED THAT THIS IS THE FOURTH TIME THIS SAME SITUATION HAS OCCURRED. A NEW KIT WAS OBTAINED AND USED. THE PATIENT WAS NOT AFFECTED AND NO MEDICAL INTERVENTION WAS REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24464020 ↗
• MalfunctionFeb 26, 2026Component Missing; Air/Gas in Device

  ACCORDING TO THE FACILITY, A CATHETER CHANGE KIT WAS OPENED AND IT WAS NOTED THAT THE BLACK CAP WAS NOT PRESENT ON THE SYRINGE AND THERE WAS A LARGE AMOUNT OF AIR IN THE SYRINGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24456136 ↗
• MalfunctionFeb 25, 2026Appropriate Device Problem Term/Code Not Available

  AIR IN SYRINGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24444075 ↗