Alaris, SmartSite 2423-0007Recalls & reported problems
BD Switzerland Sàrl · Pump Infusion Set, Back Check Valve, 2 Ganged 4-Way Stopcocks, 4 Y-Sites, 345 cm (136 in) · Class 2
All models of Alaris, SmartSite (160)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
2 open recalls name this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This BD Alaris SmartSite infusion set is tubing with back check valves, stopcocks and Y-sites for infusion pumps. Reports mostly describe leaking or splashing fluid, along with loose connections, flow problems and backflow; some mention tubing twisting or separating. There are 61 reports, with no deaths and no injuries. Two open recalls, started August 2026 and July 2025, say performance data discrepancies may make the pump run outside its expected flow and bolus accuracy.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 48
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 2
Summary
The FDA's MAUDE database contains 48 adverse event reports that list this exact device (DI 07613203020985), received between Jun 24, 2020 and Sep 21, 2026 — classified as 48 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (27 reports).
2 FDA recall records name this device's identifier, 2 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, 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
Recalls naming this device
- Aug 19, 2026Class IOpen, Classified
Due to discrepancies in specific attributes in the performance data for infusion sets, which may lead to inappropriate pump performance.
Z-3080-2026 · Root cause: Device Design · Recall details · FDA record ↗
- Jul 8, 2025Class IOpen, Classified
Infusion pump module used with compatible pump infusion sets may perform outside the established performance ranges for flow rate and bolus accuracy, downstream and upstream occlusion time to alarm, and post-occlusion bolos volume.
Z-2180-2025 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Most reported problems
Device problems
- Leak/Splash27
- Infusion or Flow Problem6
- Material Twisted/Bent6
- Backflow3
- Break3
- Fluid/Blood Leak3
- Loose or Intermittent Connection3
- Crack2
Patient problems
- No Clinical Signs, Symptoms or Conditions30
- No Consequences Or Impact To Patient19
- Insufficient Information1
Recent adverse event reports
The 25 most recent of 48 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 21, 2026Material Twisted/Bent
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50846052 ↗MalfunctionSep 18, 2026Material Puncture/Hole
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50830713 ↗MalfunctionJul 2, 2026Loose or Intermittent Connection
IT WAS REPORTED THAT THE BD ALARIS SMARTSITE PUMP INFUSION SET HAD A LOOSE COMPONENT WITH A LEAK. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE HAD ANOTHER COME LOSE AND THE MEDICATION HAD TO BE REDOSED (SUGAMADEX A REVERSAL MEDICATION). BLOOD WAS COMING OUT OF THE TUBING WHERE DISCONNECTED. PLEASE PROVIDE THE BATCH# OR LOT# NUMBER FOR THE ISSUE REPORTED ON 05JUN? I DON'T HAVE LOT # SINCE THEY STARTED IN ANOTHER AREA. DESCRIBE ANY PATIENT¿S HARM, INJURY, COMPLICATION OR NEGATIVE OUTCOME THAT OCCURRED AS A RESULT OF THE EVENT FROM (B)(6). (B)(6) THE REVERSAL MED HAD TO BE REDOSED SINCE LINE CAME OUT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25692795 ↗MalfunctionJun 15, 2026Leak/Splash; Loose or Intermittent Connection
IT WAS REPORTED THAT BD ALARIS SMARTSITE PUMP INFUSION SET WAS SEPARATED THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM IT WAS REPORTED BY A CUSTOMER THAT THE TUBING COME LOSE AND THE MEDICATION HAD TO BE REDOSED. ALSO THE TUBING'S COMING DISCONNECTED AT THE STOPCOCKS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25508175 ↗MalfunctionJun 15, 2026Leak/Splash; Loose or Intermittent Connection
IT WAS REPORTED THAT BD ALARIS SMARTSITE PUMP INFUSION SET WAS SEPARATED THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM IT WAS REPORTED BY A CUSTOMER THAT THE TUBING COME LOSE AND THE MEDICATION HAD TO BE REDOSED. ALSO THE TUBING'S COMING DISCONNECTED AT THE STOPCOCKS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25508133 ↗MalfunctionJun 1, 2026Material Separation
IT WAS REPORTED THAT THE BD ALARIS SMARTSITE PUMP INFUSION SET HAD SEPARATED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PRODUCT BROKE / CAME APART AFTER PUMP PRIMING. THIS IS THE 2ND BD IV SET IN 4 DAYS I HAVE HAD INQUIRY AT 2 DIFFERENT FACILITIES. THE OTHER ITEM WAS 2423-0007 LOT 1026015706.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25352866 ↗MalfunctionJun 1, 2026Material Separation
IT WAS REPORTED THAT THE BD ALARIS SMARTSITE PUMP INFUSION SET HAD SEPARATED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PRODUCT BROKE / CAME APART AFTER PUMP PRIMING. THIS IS THE 2ND BD IV SET IN 4 DAYS I HAVE HAD INQUIRY AT 2 DIFFERENT FACILITIES. THE OTHER ITEM WAS 2423-0007 LOT 1026015706.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25352860 ↗MalfunctionMay 31, 2026Break
IT WAS REPORTED THAT THE BD ALARIS PUMP MODULE SMARTSITE INFUSION SET HAD DAMAGED TUBING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY CUSTOMER THAT THE TUBING BREAKING OFF FROM THE CONNECTION PORT. ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER: DESCRIBE ANY PATIENT HARM, INJURY, COMPLICATION OR NEGATIVE OUTCOME THAT OCCURRED AS A RESULT OF THE EVENT. NO PATIENT HARM WAS EXPERIENCED AS I KNOW OF.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25344369 ↗MalfunctionMay 31, 2026Break
IT WAS REPORTED THAT THE BD ALARIS PUMP MODULE SMARTSITE INFUSION SET HAD DAMAGED TUBING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY CUSTOMER THAT THE TUBING BREAKING OFF FROM THE CONNECTION PORT. ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER: DESCRIBE ANY PATIENT HARM, INJURY, COMPLICATION OR NEGATIVE OUTCOME THAT OCCURRED AS A RESULT OF THE EVENT. NO PATIENT HARM WAS EXPERIENCED AS I KNOW OF.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25344280 ↗MalfunctionApr 15, 2026Backflow; Fluid/Blood Leak
IT WAS REPORTED THAT THE BD ALARIS SMARTSITE PUMP INFUSION SET HAD LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: OUR SURGICENTER IDENTIFIED A PROBLEM WITH THIS IV TUBING. IT APPEARS TO BE LEAKING AND AT TIMES CAUSING A BACKFLOW OF BLOOD. WE CURRENTLY HAVE FIVE DIFFERENT LOT NUMBERS IN CIRCULATION, AND WE WERE ABLE TO DETERMINE THAT LOT # 25125448 ALARIS PUMP INFUSION SET 2423-0007 IS THE ONE CAUSING THE ISSUE. WE HAVE ALREADY REMOVED ALL UNITS FROM THIS LOT FROM BOTH THE DEPARTMENT AND OUR STOREROOM. THE FIRST INCIDENTS OCCURRED ON 25-03-2026 AND THERE HAVE BEEN SUBSEQUENT INCIDENCES. THE IMPACT TO THE PATIENT WAS TO SEE THE AMOUNT OF BLOOD IN THE LINE THAT BACK FLOWED. IT WAS ALARMING TO THE PATIENTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24888852 ↗MalfunctionApr 7, 2026Material Twisted/Bent
IT WAS REPORTED TUBING KINK ISSUE, ALARIS SMARTSITE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24805516 ↗MalfunctionMar 18, 2026Infusion or Flow Problem; Material Twisted/Bent
IT WAS REPORTED THAT BD ALARIS SMARTSITE PUMP INFUSION SET HAD A KINK THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM IT WAS REPORTED BY CUSTOMER THAT THE KINKING IS OCCURRING IMMEDIATELY UPON REMOVAL FROM THE PACKAGING AND THEY EXPERIENCED FLOW ISSUES AND STUCK A PATIENT UNDER THE ASSUMPTION THE IV WAS FAILING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24627821 ↗MalfunctionMar 16, 2026Material Twisted/Bent
IT WAS REPORTED THAT BD ALARIS SMARTSITE PUMP INFUSION SET WAS KINKED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24606824 ↗MalfunctionMar 13, 2026Material Twisted/Bent
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24589721 ↗MalfunctionFeb 16, 2026Leak/Splash
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24349219 ↗MalfunctionFeb 16, 2026Leak/Splash
FAULTY IV TUBING OCCURRING ABOUT 3 DIFFERENT EPISODES WITH 4 DIFFERENT IV TUBING. LOT 10 250 954 99, EXP 91428 BD ALARIS PUMP INFUSION SET WITH BACKCHECK VALVE. WHEN HOOKING TO IV CATHETER, IT LEAKED AROUND THE IV CATHETER HUB.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24345767 ↗MalfunctionFeb 16, 2026Leak/Splash
IT IS REPORTED LEAKAGE. FAULTY IV TUBING OCCURRING ABOUT 3 DIFFERENT EPISODES WITH 4 DIFFERENT IV TUBING. LOT: 10, 250 954 99, EXP: 91428 BD ALARIS PUMP INFUSION SET WITH BACKCHECK VALVE. WHEN HOOKING TO IV CATHETER, IT LEAKED AROUND THE IV CATHETER HUB. NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24345557 ↗MalfunctionFeb 16, 2026Leak/Splash
IT IS REPORTED LEAKAGE. FAULTY IV TUBING OCCURRING ABOUT 3 DIFFERENT EPISODES WITH 4 DIFFERENT IV TUBING. LOT: 10 250 954 99, EXP: 91428 BD ALARIS PUMP INFUSION SET WITH BACKCHECK VALVE. WHEN HOOKING TO IV CATHETER, IT LEAKED AROUND THE IV CATHETER HUB.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24345555 ↗MalfunctionJan 20, 2026Leak/Splash
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24120997 ↗MalfunctionJan 20, 2026Leak/Splash
IT WAS REPORTED THAT BD ALARIS SMARTSITE PUMP INFUSION SET WAS LEAKING. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM: IT WAS REPORTED BY CUSTOMER THAT LEAKAGE AROUND THE IV CATHETER HUB ON CONNECTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24120717 ↗MalfunctionJan 13, 2026Material Twisted/Bent
IT WAS REPORTED THAT BD ALARIS SMARTSITE PUMP INFUSION SET WAS KINKING THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING IT WAS REPORTED BY CUSTOMER THAT "KINKING IN THE SETS NEAR A Y-SITE."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24058631 ↗MalfunctionJan 12, 2026Contamination /Decontamination Problem
IT WAS REPORTED THAT THE BD ALARIS SMARTSITE PUMP INFUSION SET HAD FOREIGN MATTER IN THE FLUID PATH. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE HAVE A COMPLAINT FROM OUR CUSTOMER ON ITEM 2423-0007/LOT# (10)25095499 DUE TO DIRTY IV TUBING. ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER: WHEN WAS THIS DEFECT OBSERVED? DURING OR BEFORE USE? THE TUBING WAS BROUGHT TO MY ATTENTION ON 12/11/2025. I WAS FOUND WHEN OPENING THE TUBING BEFORE USE. ANY ADVERSE EVENT OR SERIOUS INJURY REPORTED TO PATIENT OR HEALTHCARE PROFESSIONAL? IF YES, PLEASE PROVIDE THE DETAILS. NO EVENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24033034 ↗MalfunctionDec 16, 2025Complete Blockage; Complete Blockage
IT WAS REPORTED THAT BD ALARIS SMARTSITE PUMP INFUSION SET WAS OCCLUDED THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM. IT WAS REPORTED BY THE CUSTOMER THAT A FLUID INFUSION AT 75ML/HR. NIGHT SHIFT NURSE (B)(6) RESPONDED TO AN ¿OCCLUSION PATIENT SIDE¿ ALERT AND ¿TROUBLE SHOT¿ THE OCCLUSION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23824380 ↗MalfunctionSep 2, 2025Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT BD ALARIS SMARTSITE PUMP INFUSION SET WAS SEPARATED. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM IT WAS REPORTED BY THE CUSTOMER THAT THESE NEW YELLOW STOP COCKS THAT ARE PART OF THEIR PIV SETUP ARE A DANGER TO PATIENTS. THEY COME LOOSE VERY EASILY. EVEN AFTER YOU TIGHTEN THEM TO THE PIV TUBING. THEY COME APART DURING IV SEDATION CASES WITH PROPOFOL. THIS CAN LEAD TO AWARENESS AND PATIENT'S BLOOD POOLING BACK OUT OF THE TUBING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22935466 ↗MalfunctionJul 8, 2024Crack; Crack
NO ADDITIONAL INFO.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 19697256 ↗
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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 · each recall links to the FDA recall notice
- 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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