Medline Industries, Inc. PAIN1062BRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10193489247640), received between Nov 18, 2025 and Dec 2, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 2, 2025Fluid/Blood Leak; Fluid/Blood Leak

  ACCORDING TO THE FACILITY, ON (B)(6) 2025, WHILE TRYING TO ADMINISTER DYE FOR AN EPIDURAL, THE 10 ML SYRINGE WAS LEAKING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23698044 ↗
• MalfunctionNov 18, 2025Fluid/Blood Leak; Leak/Splash; Fluid/Blood Leak; Leak/Splash

  IT WAS REPORTED THAT "THE 10CC SYRINGES IN THE PRE PACKAGED EPIDURAL TRAYS ARE LEAKING." THE CUSTOMER REPORTED THAT THE LEAKAGE OCCURRED WHILE "TRYING TO ADMINISTER DYE FOR AN EPIDURAL."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23581924 ↗