EM L280-220KRecalls & reported problems
Allied Medical, LLC · REG,O2,540 0-25 BARB 2CKS · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00026072021989), received between Jan 2, 2024 and May 20, 2024 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Fracture” (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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Fracture1
- Gas/Air Leak1
- Material Twisted/Bent1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 20, 2024Fracture; Fracture
IT WAS REPORTED THAT THE DEVICE WAS DAMAGED. THIS OCCURRED DURING PRIMING AT THE FACILITY, NO PATIENT INVOLVEMENT AND NO PATIENT HARM/ADVERSE EVENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19352452 ↗MalfunctionJan 2, 2024Gas/Air Leak; Material Twisted/Bent; Gas/Air Leak; Material Twisted/Bent
IT WAS REPORTED THAT THE PRODUCT IS BENT AND HAS A LEAK. THERE WAS NO PATIENT INVOLVEMENT. NO HARM REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18432386 ↗
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- Drive 18302GDELDrive Devilbiss Healthcare · REGULATOR, PRESSURE, GAS CYLINDER1 death1 report
- 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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