Medline HCS8708MRecalls & reported problems
Medline Industries, Inc. · REGULATOR,O2,MINI 0-8 L,870 CGA · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 10
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 40080196226529), received between Aug 17, 2026 and Sep 18, 2026 — classified as 10 malfunctions.
The most frequently reported specific device problem is “Gas/Air Leak” (8 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.
Reports received per month
Most reported problems
Device problems
- Gas/Air Leak8
- Break1
- Component Missing1
- Inaccurate Flow Rate1
Patient problems
- No Clinical Signs, Symptoms or Conditions10
Recent adverse event reports
The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 18, 2026Gas/Air Leak
This VMSR report summarizes 2 malfunction events that occurred between (b)(6) 2024. The account reported that oxygen regulators (HCS8708M) were leaking during use. No patient information was available. No patient or user injuries were reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50819131 ↗MalfunctionSep 18, 2026Gas/Air Leak
This summary report covers malfunction events that occurred between October 1 and December 31, 2024. This VMSR summarizes one malfunction event involving two Medline oxygen regulators (catalog number: HCS8708M). The account reported that the regulators were leaking from the body, not the gasket. The devices were not returned; photographs were reviewed, and the reported malfunction and its cause could not be confirmed. No patient information was available. No patient or user injuries were reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50818722 ↗MalfunctionSep 9, 2026Inaccurate Flow Rate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50698444 ↗MalfunctionSep 7, 2026Gas/Air Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50657455 ↗MalfunctionAug 27, 2026Gas/Air Leak
It was reported that "We have a O2 Regulator that is not working. It is spewing air from it,".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50472976 ↗MalfunctionAug 18, 2026Gas/Air Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50308565 ↗MalfunctionAug 18, 2026Gas/Air Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50307769 ↗MalfunctionAug 18, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50302379 ↗MalfunctionAug 17, 2026Gas/Air Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50283321 ↗MalfunctionAug 17, 2026Component Missing; Gas/Air Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50278886 ↗
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- Western/Scott Fetzer M1-540-15FMWestern Enterprises · Regulator, Pressure, Gas Cylinder1 report
- MediTec 0721109USGCE, s.r.o. · Regulator, Pressure, Gas Cylinder1 report
- Cavagna VIPROXY 1 TouchCavagna North America Inc · Regulator, Pressure, Gas Cylinder1 report
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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