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MEDLINE DYNJSC301Recalls & reported problems

Medline Industries, Inc. · STOPCOCK,3-WAY,45,PSI,LOW,OFF,ROT,COLAR · Class 2

Adverse event reports
42
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 42 adverse event reports that list this exact device (DI 10884389734568), received between Sep 18, 2026 and Sep 30, 2026 — classified as 42 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (38 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. How this data works · Data updated Oct 13, 2026.

Reports received per month

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 42 reportsOct 2026: 0 reports20242025202642
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Fluid/Blood Leak38
  • Gas/Air Leak4
  • Material Split, Cut or Torn3
  • Fungus in Device Environment2
  • Crack1
  • Material Rupture1
  • Structural Problem1

Patient problems

  • No Clinical Signs, Symptoms or Conditions41
  • Hemorrhage/Blood Loss/Bleeding1

Recent adverse event reports

The 25 most recent of 42 reports, in the reporter's own words as published by the FDA.

  • MalfunctionSep 30, 2026Fluid/Blood Leak

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50950975 ↗
  • MalfunctionSep 30, 2026Fluid/Blood Leak

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50950653 ↗
  • MalfunctionSep 30, 2026Fluid/Blood Leak

    It was reported that ITEMS HAVE BEEN LEAKING DUE TO SMALL CRACK.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50945905 ↗
  • MalfunctionSep 30, 2026Fluid/Blood Leak

    It was reported that "Leaking stopcocks."

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50945518 ↗
  • MalfunctionSep 30, 2026Fluid/Blood Leak

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50945455 ↗
  • MalfunctionSep 30, 2026Fluid/Blood Leak

    It was reported that "The team had one of the stopcocks that was leaking and it is leaking out the bottom. Looks to be an issue with the turning valve itself."

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50941624 ↗
  • MalfunctionSep 29, 2026Fluid/Blood Leak

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50932994 ↗
  • MalfunctionSep 28, 2026Fluid/Blood Leak

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50918089 ↗
  • MalfunctionSep 28, 2026Crack; Gas/Air Leak

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50917697 ↗
  • MalfunctionSep 28, 2026Fluid/Blood Leak

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50917380 ↗
  • MalfunctionSep 28, 2026Fluid/Blood Leak; Fungus in Device Environment

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50916640 ↗
  • MalfunctionSep 28, 2026Gas/Air Leak

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50916321 ↗
  • MalfunctionSep 28, 2026Fluid/Blood Leak; Material Split, Cut or Torn

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50916063 ↗
  • MalfunctionSep 28, 2026Fluid/Blood Leak; Material Split, Cut or Torn

    It was reported that Leaking stopcock.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50914808 ↗
  • MalfunctionSep 28, 2026Gas/Air Leak

    It was reported that "THE STOPCOCKS ARE LEAKING AIR WHEN THEY ARE TRYING TO USE THEM."

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50912787 ↗
  • MalfunctionSep 27, 2026Fluid/Blood Leak

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50910493 ↗
  • MalfunctionSep 26, 2026Fluid/Blood Leak; Fungus in Device Environment

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50906567 ↗
  • MalfunctionSep 25, 2026Fluid/Blood Leak; Gas/Air Leak

    It was reported that "Some of our stopcocks from Medline have been failing and have a leak" and "They seem to have a leak in the hole on the backside of the device, on the opposite side of the knob."

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50900419 ↗
  • MalfunctionSep 25, 2026Fluid/Blood Leak

    It was reported that "WHILE FLUIDS AND MEDICINE ARE IVed TO THE PATIENT THE DEVICE LEAKS FROM THE BOTTOM."

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50900061 ↗
  • MalfunctionSep 25, 2026Fluid/Blood Leak

    It was reported that STOPCOCKS ARE LEAKING.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50898844 ↗
  • MalfunctionSep 24, 2026Fluid/Blood Leak

    It was reported that "we have 2 lot# 3 way low pressure stopcock with rotating male collar REF#(b)(6), SIN#2157161 that are defective and leak out of the valve."

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50884102 ↗
  • MalfunctionSep 24, 2026Fluid/Blood Leak

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50884077 ↗
  • MalfunctionSep 24, 2026Fluid/Blood Leak

    It was reported that product is leaking at the hub.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50882450 ↗
  • MalfunctionSep 23, 2026Fluid/Blood Leak

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50869678 ↗
  • MalfunctionSep 23, 2026Fluid/Blood Leak

    It was reported that "Leaking issues on item # DYNJSC301 ¿ lot # 22IBS919."

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50868947 ↗

Other Adaptor, stopcock, manifold, fitting, cardiopulmonary bypass devices

All Adaptor, stopcock, manifold, fitting, cardiopulmonary bypass devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.