Medline Industries, Inc. DYNJ51615NRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10195327418946), received between Feb 26, 2024 and Apr 8, 2024 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Crack” (2 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. Mar 24, 2026Open, Classified

   Medline has identified the presence of particulate within the fluid path of the Manifolds.

   Z-2144-2026 · Root cause: Under Investigation by firm · FDA record ↗

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 8, 2024Break; Crack; Break; Crack

  IT WAS REPORTED THAT A CONTROL SYRINGE COMPONENT WAS FOUND TO BE "BROKEN AND CRACKED" WITHIN THE PACK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19060395 ↗
• InjuryApr 4, 2024Material Frayed; Material Frayed

  ACCORDING TO THE CUSTOMER, DURING A PROCEDURE AFTER THE TOWELS GOT WET WITH "BLOOD AND FLUIDS", THERE WAS "LINT" FROM THE TOWELS NOTED ON THE PHYSICIAN'S GLOVES AND "THE INTERVENTIONAL WIRE AS THE PHYSICIAN WAS INSERTING A IVUS CATHETER".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19043354 ↗
• MalfunctionFeb 26, 2024Crack; Crack

  IT WAS REPORTED THAT A CONTROL SYRINGE COMPONENT WAS CRACKED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18777279 ↗