Vital Signs™ 9810Recalls & reported problems
Sunmed, LLC · Vital Signs™ Uni-Lim™ Anesthesia Circuit Kit, 72" Coaxial Circuit, Patient Elbow with Capped Gas Sample Port, M/M GSL 10', 2 B/V Filter, 3 L Latex-Free Breathing Bag, Disposable · Class 2
All models of Vital Signs (3)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10889483300039), received between Jan 1, 2026 and Jan 9, 2026 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Loose or Intermittent Connection” (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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Loose or Intermittent Connection2
Patient problems
- Low Oxygen Saturation1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 9, 2026Loose or Intermittent Connection
IT WAS REPORTED, PRIOR TO ADMINISTRATION OF THE ANESTHESIA TO THE PATIENT THE ELBOW SEPARATED FROM THE CIRCUIT AND THE CIRCUIT END FELL TO THE GROUND WHILE THE ELBOW REMAINED ON THE ANESTHESIA MACHINE. THE EVENT RESULTED IN A DELAY IN TREATMENT FOR THE PATIENT; THE CIRCUIT WAS RECONNECTED AND USED ON THE PATIENT. THERE WAS NO REPORT OF HARM OR INJURY AS A RESULT OF THIS REPORTED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24021976 ↗InjuryJan 1, 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 THIRD OF THREE REPORTS. REFER TO 1314417-2026-00002 FOR THE SECOND REPORT. IT WAS REPORTED, THE CIRCUIT DISCONNECTED MULTIPLE TIMES, WHICH HAS RESULTED IN THE PATIENT DESATURATING, DOWN INTO THE 60S. NO INFORMATION WAS PROVIDED CONCERNING MEDICAL INTERVENTION OR PATIENT OUTCOME.
Patient problems: Low Oxygen Saturation
MAUDE report 23940760 ↗
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- GIBECK IPN043751Teleflex Incorporated · Filter, bacterial, breathing-circuit2 recalls7 reports
- VOCSN VOCSN, EnglishVentec Life Systems, Inc. · Filter, Bacterial, Breathing-Circuit1 death96 reports
- VOCSN V+C+Pro, JapaneseVentec Life Systems, Inc. · Filter, Bacterial, Breathing-Circuit1 recall33 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 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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