Vital SignsRecalls & reported problems across all models
Sunmed, LLC · 3 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names at least one Vital Signs model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls
- 1
We found 3 models of Vital Signs by Sunmed, LLC in the FDA's device registry (GUDID). Together they are named in 5 adverse event reports in the FDA's MAUDE database, received between Jan 1, 2026 and Feb 13, 2026 — classified as 1 injury, 4 malfunctions.
The most frequently reported specific device problem is “Loose or Intermittent Connection” (5 reports).
1 FDA recall record name at least one of these models by its device identifier, 1 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Vital Signs recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Oct 11, 2023Class IIOpen, Classified
A backwards leak present in the integrated manometer of the patient valve allows for CO2 rebreathing.
Z-0365-2024 · Root cause: Device Design · Recall details · FDA record ↗
Most reported Vital Signs problems
Device problems
- Loose or Intermittent Connection5
Patient problems
- No Clinical Signs, Symptoms or Conditions4
- Low Oxygen Saturation1
Vital Signs models
3 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Vital Signs™ 9362Filter, Bacterial, Breathing-Circuit1 recall0 reports
- Vital Signs™ 9665Filter, Bacterial, Breathing-Circuit3 reports
- Vital Signs™ 9810Filter, Bacterial, Breathing-Circuit2 reports
Recent Vital Signs adverse event reports
The 5 most recent reports across all models, 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 ↗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 ↗
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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