Vital Signs™ 9665Recalls & reported problems
Sunmed, LLC · Vital Signs™ Anesthesia Circuit Kit, 96" Expandable Dual Limb Circuit, Patient Elbow with Capped Gas Sample Port, In-Line Mini HMEF with Sample Port, Size 6 Large Adult Mask, M/M GSL 10', 3 L Latex-Free Breathing Bag, Disposable · Class 2
- 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 10889483222522), received between Feb 13, 2026 and Feb 13, 2026 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Loose or Intermittent Connection” (3 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Loose or Intermittent Connection3
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 13, 2026Loose or Intermittent Connection
IT WAS REPORTED DURING USE, THE CIRCUIT HAD A LOOSE CONNECTION WHEN HOOKED TO THE ANESTHESIA MACHINE AND IT EASILY DISCONNECTED FROM THE CIRCUIT WHEN MOVED, EVEN AFTER A ¼ TWIST TO PRESSURE SEAL IT. THERE WAS NO REPORT OF A DELAY IN THERAPY, HARM OR INJURY AS A RESULT OF THIS REPORTED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24337206 ↗MalfunctionFeb 13, 2026Loose or Intermittent Connection
SUNMED HOLDINGS LLC. RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THREE DIFFERENT PATIENTS. THIS IS THE SECOND OF THREE REPORTS. REFER TO 2028807-2026-00003 FOR THE FIRST REPORT REFER TO 2028807-2026-00005 FOR THE THIRD REPORT IT WAS REPORTED DURING USE, THE CIRCUIT HAD A LOOSE CONNECTION WHEN HOOKED TO THE ANESTHESIA MACHINE AND IT EASILY DISCONNECTED FROM THE CIRCUIT WHEN MOVED, EVEN AFTER A ¼ TWIST TO PRESSURE SEAL IT. THERE WAS NO REPORT OF A DELAY IN THERAPY, HARM OR INJURY AS A RESULT OF THIS REPORTED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24336696 ↗MalfunctionFeb 13, 2026Loose or Intermittent Connection
IT WAS REPORTED DURING USE, THE CIRCUIT HAD A LOOSE CONNECTION WHEN HOOKED TO THE ANESTHESIA MACHINE AND IT EASILY DISCONNECTED FROM THE CIRCUIT WHEN MOVED, EVEN AFTER A ¼ TWIST TO PRESSURE SEAL IT. THERE WAS NO REPORT OF A DELAY IN THERAPY, HARM OR INJURY AS A RESULT OF THIS REPORTED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24336624 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.