Medline Industries, Inc. DYNJ44087BRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10195327346584), received between Dec 3, 2024 and Feb 26, 2026 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Crack” (4 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. Nov 15, 2023Class IOpen, Classified

   Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components): 0.9% Sodium Chloride Irrigation USP, Sterile Water for Irrigation USP and Saline Flush Syringe. Nurse Assist issued a recall due to the potential lack of sterility, which could result in the solution being non sterile.

   Z-1096-2024 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

2. May 18, 2023Class IIOpen, Classified

   Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.

   Z-2163-2023 · Root cause: Device Design · 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.

• MalfunctionFeb 26, 2026Crack; Material Integrity Problem

  SYRINGE CRACKING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24462733 ↗
• MalfunctionFeb 24, 2026Crack

  ACCORDING TO THE FACILITY ON (B)(6) 2026, DURING A DIAGNOSTIC ANGIOGRAM, THE DOCTOR USED A 10 CC SYRINGE TO DRAW BACK BLOOD INTO A CONTRAST-FILLED SYRINGE AND THEN PUSHED FORWARD AS PART OF THE STANDARD PROCESS, AND THE 10 CC SYRINGES CRACKED UNDER NORMAL PRESSURE, CAUSING A CONSIDERABLE AMOUNT OF BLOODBORNE PATHOGENS TO SPLATTER STAFF AND EQUIPMENT.

  Patient problems: Exposure to Body Fluids

  MAUDE report 24433668 ↗
• MalfunctionDec 3, 2024Crack; Crack

  CRACKED SYRINGE.

  Patient problems: Insufficient Information

  MAUDE report 20835682 ↗
• MalfunctionDec 3, 2024Crack; Crack

  CRACKED SYRINGE.

  Patient problems: Exposure to Body Fluids

  MAUDE report 20833588 ↗