Alaris, SmartSite 25208ERecalls & reported problems
BD Switzerland Sàrl · Extension Set, 4 Way Stopcock 3 Ganged Lipid Resistant Needle-Free Valve, 86 cm (34in) · Class 2
All models of Alaris, SmartSite (160)
Data updated Oct 18, 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 10885403235160), received between Aug 26, 2025 and Nov 3, 2025 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Fluid/Blood Leak1
- Infusion or Flow Problem1
- Leak/Splash1
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.
MalfunctionNov 3, 2025Fluid/Blood Leak; Fluid/Blood Leak
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23449285 ↗MalfunctionNov 3, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED THAT BD ALARIS SMARTSITE EXTENSION SET WAS LEAKING THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM IT WAS REPORTED BY CUSTOMER THAT THEY ARE FINDING LEAKING ON THE BED AND BACKING UP OF BLOOD.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23448892 ↗MalfunctionAug 26, 2025Infusion or Flow Problem; Infusion or Flow Problem
IT WAS REPORTED THAT BD ALARIS SMARTSITE EXTENSION SET HAD FLOW ISSUES. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM IT WAS REPORTED BY CUSTOMER THAT THAT THEY TRIED REF# 25208E AND THAT IS CLOSER BUT THE ANESTHESIA PROVIDERS SAY IT DOESN'T TELL YOU WHEN IT IS LOCKED OFF. IT TAKES A 180 DEGREE TURN OR MORE AND IT HAS ALREADY CAUSED SOME ISSUES WITH PATIENTS WITH GETTING TOO MUCH MEDS OR FLUIDS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22895535 ↗
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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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