Medline HCS4568SRecalls & reported problems
Medline Industries, Inc. · CO2 CANNULA,SUPERSOFT, ADLT,7'O2,7'CO2 · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10888277716780), received between Apr 1, 2026 and Sep 30, 2026 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Connection Problem” (2 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
- Connection Problem2
- Incomplete or Inadequate Connection1
- Obstruction of Flow1
Patient problems
- Low Oxygen Saturation2
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Obstruction of Flow; Incomplete or Inadequate Connection
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50955065 ↗MalfunctionApr 3, 2026Connection Problem
SUNMED HOLDINGS LLC. RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING TWO DIFFERENT PATIENTS. THIS IS THE FIRST OF TWO REPORTS. REFER TO 1314417-2026-00018 FOR THE SECOND REPORT. IT WAS REPORTED, THE OXYGEN AND CARBON DIOXIDE (CO2) LINES AND PRONGS WERE REVERSED AND THE PATIENT WERE NOT GETTING ANY OXYGEN. THERE WAS NO REPORT OF SERIOUS HARM OR INJURY AS A RESULT OF THIS REPORTED EVENT.
Patient problems: Low Oxygen Saturation
MAUDE report 24776317 ↗MalfunctionApr 1, 2026Connection Problem
SUNMED HOLDINGS LLC. RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING TWO DIFFERENT PATIENTS. THIS IS THE SECOND OF TWO REPORTS. REFER TO 1314417-2026-00017 FOR THE FIRST REPORT. IT WAS REPORTED, THE OXYGEN AND CARBON DIOXIDE (CO2) LINES AND PRONGS WERE REVERSED AND THE PATIENT WERE NOT GETTING ANY OXYGEN. THERE WAS NO REPORT OF SERIOUS HARM OR INJURY AS A RESULT OF THIS REPORTED EVENT.
Patient problems: Low Oxygen Saturation
MAUDE report 24760983 ↗
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- NA GF-210RNihon Kohden Corporation · ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE386 reports
- Trilogy IT2110X21BRespironics, Inc. · ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE5 recalls30 reports
- Trilogy Trilogy Evo Ventilator, GermanyRespironics, Inc. · ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE5 recalls26 reports
- Trilogy Evo Trilogy Evo Ventilator with oxygen blending model, GermanyRespironics, Inc. · ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE5 recalls9 reports
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 13, 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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