Medline Industries, Inc. DYNJ61982DRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10195327597252), received between Aug 10, 2026 and Aug 18, 2026 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Component Misassembled” (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 18, 2026.

Recalls naming this device

1. Mar 24, 2026Class IOpen, Classified

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

   Z-2145-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

2. Feb 27, 2026Class IOpen, Classified

   Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.

   Z-1718-2026 · Root cause: Under Investigation by firm · Recall details · 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.

• MalfunctionAug 18, 2026Component Misassembled

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50301883 ↗
• MalfunctionAug 12, 2026Component Misassembled

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50226274 ↗
• MalfunctionAug 10, 2026Break

  It was reported that the tubing on the manifold that goes to the patient was kinked and when he tried to unkink it, the tubing pulled off completely.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50197371 ↗
• MalfunctionAug 10, 2026Material Frayed

  It was reported that "After a doctor wiped off hands with a wet sterile towel, he dunked his hands into the bowl which they noticed the lint occurring."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50195866 ↗