Western/Scott Fetzer M1-540-15FMRecalls & reported problems
Western Enterprises · REG M1 SERIES FLOWMETER STYLE · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI B929M154015FM0), received between Mar 7, 2023 and Mar 7, 2023 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Rupture” (1 report).
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
Device problems
- Material Rupture1
- Use of Device Problem1
Patient problems
- Insufficient Information1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 7, 2023Material Rupture; Use of Device Problem
AN ADULTERATED MEDICAL GAS FLOWMETER RUPTURED DURING A NONMEDICAL APPLICATION OF THE DEVICE USED OUTSIDE THE SPECIFIED TEMPERATURE RANGE.
Patient problems: Insufficient Information
MAUDE report 16494986 ↗
Other Regulator, Pressure, Gas Cylinder devices
- ISPAN 8065797303Alcon Laboratories, Inc. · REGULATOR, PRESSURE, GAS CYLINDER56 reports
- Medline HCS8708MMedline Industries, Inc. · REGULATOR, PRESSURE, GAS CYLINDER10 reports
- Medline HCS8715MAMedline Industries, Inc. · REGULATOR, PRESSURE, GAS CYLINDER9 reports
- EM L280-220KAllied Medical, LLC · Regulator, Pressure, Gas Cylinder2 reports
- Mini CGA 870 style regulator; 0-15 lpm RES043Sunset Healthcare Solutions, Inc. · Regulator, Pressure, Gas Cylinder2 reports
- Drive 18302GMNDrive Devilbiss Healthcare · REGULATOR, PRESSURE, GAS CYLINDER1 report
- Cavagna VIPROXY 1 TouchCavagna North America Inc · Regulator, Pressure, Gas Cylinder1 report
- Drive 18302GDELDrive Devilbiss Healthcare · REGULATOR, PRESSURE, GAS CYLINDER1 death1 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page