Medline Industries, Inc. DYNJ60655FRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10198459214615), received between May 13, 2025 and May 1, 2026 — classified as 4 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Material Integrity Problem” (5 reports).

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.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryMay 1, 2026Material Integrity Problem

  ACCORDING TO THE CUSTOMER, A CONCERN INVOLVING POSSIBLE CEREBROVASCULAR ACCIDENT TYPE SYMPTOMS IDENTIFIED POST-PROCEDURE IN FIVE PATIENTS WHO UNDERWENT DIAGNOSTIC ARTERIOGRAMS IN CAIR WAS REPORTED. IT WAS REPORTED THAT "THERE IS A WORKING HYPOTHESIS THAT A RESIDUE ASSOCIATED WITH THE RAY-TECS MAY BE PRESENT AND POTENTIALLY TRANSFERRING INTO HEPARINIZED SALINE BOWLS DURING PROCEDURAL SETUP."

  Patient problems: Stroke/CVA

  MAUDE report 25058859 ↗
• InjuryMay 1, 2026Material Integrity Problem

  "THERE IS A WORKING HYPOTHESIS THAT A RESIDUE ASSOCIATED WITH THE RAY-TECS MAY BE PRESENT AND POTENTIALLY TRANSFERRING INTO HEPARINIZED SALINE BOWLS DURING PROCEDURAL SETUP".

  Patient problems: Stroke/CVA

  MAUDE report 25058694 ↗
• InjuryMay 1, 2026Material Integrity Problem

  "THERE IS A WORKING HYPOTHESIS THAT A RESIDUE ASSOCIATED WITH THE RAY-TECS MAY BE PRESENT AND POTENTIALLY TRANSFERRING INTO HEPARINIZED SALINE BOWLS DURING PROCEDURAL SETUP".

  Patient problems: Stroke/CVA

  MAUDE report 25058130 ↗
• InjuryMay 1, 2026Material Integrity Problem

  "THERE IS A WORKING HYPOTHESIS THAT A RESIDUE ASSOCIATED WITH THE RAY-TECS MAY BE PRESENT AND POTENTIALLY TRANSFERRING INTO HEPARINIZED SALINE BOWLS DURING PROCEDURAL SETUP."

  Patient problems: Stroke/CVA

  MAUDE report 25057603 ↗
• MalfunctionJun 9, 2025Material Integrity Problem; Material Integrity Problem

  SYRINGE BROKE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22166382 ↗
• MalfunctionMay 13, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  SYRINGE HAS NO GRADATIONS ON 10 ML, LUER LOCK SCREW NOT LINING UP AND MALFORMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22013230 ↗