Alaris 25206Recalls & reported problems
BD Switzerland Sàrl · Extension Set, 4-way Stopcock 81 cm (32 in) · Class 2
All models of Alaris (85)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10885403233296), received between Jul 15, 2023 and Jul 21, 2023 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (4 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.
Most reported problems
Device problems
- Leak/Splash4
- Loose or Intermittent Connection4
Patient problems
- No Clinical Signs, Symptoms or Conditions4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 21, 2023Leak/Splash; Loose or Intermittent Connection; Leak/Splash; Loose or Intermittent Connection
IT WAS REPORTED THAT DURING USE WITH BD SPECIALTY EXTENSION SETS EXPERIENCED THERE WAS A LOOSE CONNECTION CAUSING LEAKAGE. THIS IS THE 4TH OF 4 REPORTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WE HAVE HAD SOME DEFECTIVE QUALITY ISSUES ON ITEM #25206 THAT HAVE HAPPENED IN OUR OB UNIT. THEY ARE TELLING ME THAT THERE HAS BEEN 4 EPISODES OF THIS ITEM LEAKING AND THE PATIENT SIDE DOES NOT TIGHTEN WHICH HAS RESULTED WITH THE FLUIDS ON THE FLOOR. "
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17375187 ↗MalfunctionJul 18, 2023Leak/Splash; Loose or Intermittent Connection; Leak/Splash; Loose or Intermittent Connection
IT WAS REPORTED THAT THE BD SPECIALTY EXTENSION SETS EXPERIENCED A LOOSE CONNECTION CAUSING LEAKAGE. 1 OF 3 RELATED FILES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE HAVE HAD SOME DEFECTIVE QUALITY ISSUES ON ITEM #25206 THAT HAVE HAPPENED IN OUR OB UNIT. THEY ARE TELLING ME THAT THERE HAS BEEN 4 EPISODES OF THIS ITEM LEAKING AND THE PATIENT SIDE DOES NOT TIGHTEN WHICH HAS RESULTED WITH THE FLUIDS ON THE FLOOR. "
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17342616 ↗MalfunctionJul 17, 2023Leak/Splash; Loose or Intermittent Connection; Leak/Splash; Loose or Intermittent Connection
IT WAS REPORTED THAT THE BD SPECIALTY EXTENSION SETS EXPERIENCED A LOOSE CONNECTION CAUSING LEAKAGE. 1 OF 2 RELATED FILES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE HAVE HAD SOME DEFECTIVE QUALITY ISSUES ON ITEM #25206 THAT HAVE HAPPENED IN OUR OB UNIT. THEY ARE TELLING ME THAT THERE HAS BEEN 4 EPISODES OF THIS ITEM LEAKING AND THE PATIENT SIDE DOES NOT TIGHTEN WHICH HAS RESULTED WITH THE FLUIDS ON THE FLOOR. "
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17333618 ↗MalfunctionJul 15, 2023Leak/Splash; Loose or Intermittent Connection; Leak/Splash; Loose or Intermittent Connection
IT WAS REPORTED THAT THE BD SPECIALTY EXTENSION SETS EXPERIENCED A LOOSE CONNECTION CAUSING LEAKAGE. 3 OF 3 RELATED FILES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE HAVE HAD SOME DEFECTIVE QUALITY ISSUES ON ITEM #25206 THAT HAVE HAPPENED IN OUR OB UNIT. THEY ARE TELLING ME THAT THERE HAS BEEN 4 EPISODES OF THIS ITEM LEAKING AND THE PATIENT SIDE DOES NOT TIGHTEN WHICH HAS RESULTED WITH THE FLUIDS ON THE FLOOR. "
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17330481 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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