Medline HCS8715MARecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10080196193905), received between May 8, 2026 and Sep 29, 2026 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Gas/Air Leak” (7 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 16, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026Gas/Air Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50936645 ↗
• MalfunctionSep 29, 2026Gas/Air Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50936431 ↗
• MalfunctionSep 29, 2026Gas/Air Leak

  It was reported that the customer is having issues with the units leaking from the flow adjustment dial.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50933028 ↗
• MalfunctionSep 29, 2026Gas/Air Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50931352 ↗
• MalfunctionSep 24, 2026Inaccurate Flow Rate; Mechanical Problem; Gas/Air Leak

  This VMSR report summarizes 6 malfunction events that occurred between July 1 and September 30, 2023. The account reported that oxygen regulators (HCS8715MA) exhibited loose flow control dials and air leaks during use. The account further reported unstable flow settings and leakage when changing liters per minute settings. No patient information was available. No patient or user injuries were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50883758 ↗
• MalfunctionSep 22, 2026Gas/Air Leak; Improper Flow or Infusion

  It was reported that "1 MORE REGULATOR NOT PUTTING OUT THE PROPER LITER FLOW".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50856397 ↗
• MalfunctionSep 21, 2026Gas/Air Leak; Noise, Audible

  This summary report covers malfunction events that occurred between January 1 and March 31, 2024. This VMSR summarizes one malfunction event involving 30 Medline oxygen regulators (catalog number HCS8715MA). The account reported that the units appeared to be leaking from the flow adjustment dial. Evaluation of the returned devices found oxygen escaping from multiple units; two units were confirmed to leak from the flow dial, eight units exhibited a rattling sound, some units did not leak during testing, and some units could not be fully tested because components were missing. Patient demographic information was not available. No patient or user injuries were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50842598 ↗
• MalfunctionAug 31, 2026Inaccurate Flow Rate

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50530730 ↗
• MalfunctionMay 8, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT THE METAL PIECE THAT ALLOWS THE TUBING TO CONNECT TO THE REGULATOR BROKE OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25129172 ↗