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Medline Industries, Inc. DYNJAA9120Recalls & reported problems

Medline Industries, Inc. · ANES CIRC EXTENDAFLEX-LF · Class 2

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
4
Deaths reported
0
Injuries reported
2
Recalls naming it
0

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10080196827367), received between Oct 31, 2025 and Sep 25, 2026 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Crack” (3 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.

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: 1 reportsNov 2025: 0 reportsDec 2025: 1 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 1 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 1 reportsOct 2026: 0 reports2024202520261
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Crack3
  • Gas/Air Leak1
  • Manufacturing, Packaging or Shipping Problem1
  • Material Integrity Problem1

Patient problems

  • No Clinical Signs, Symptoms or Conditions3
  • Apnea1

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

  • MalfunctionSep 25, 2026Crack

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50904780 ↗
  • MalfunctionMar 3, 2026Crack

    ACCORDING TO THE FACILITY ON 2/3/2026, "THE CIRCUIT WAS NOT HOLDING PRESSURE" DURING THE CASE. THE FACILITY NOTED THAT THERE WAS A "SEAM FOUND ALONG CIRCUIT THAT WAS NOT SEALED PROPERLY" LEADING TO LEAKING.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24497717 ↗
  • InjuryDec 30, 2025Crack; Manufacturing, Packaging or Shipping Problem; Material Integrity Problem; Crack; Manufacturing, Packaging or Shipping Problem; Material Integrity Problem

    CRACK IN CIRCUIT.

    Patient problems: Apnea

    MAUDE report 23928043 ↗
  • InjuryOct 31, 2025Gas/Air Leak; Gas/Air Leak

    ACCORDING TO THE CUSTOMER, THE PRODUCT "SEEMS TO HAVE A HOLE AS THE AIR IS ESCAPING".

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23441876 ↗

Other Filter, bacterial, breathing-circuit devices

All Filter, bacterial, breathing-circuit devices →

Sources and updates

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