BD SmartSiteRecalls & reported problems across all models

We found 29 models of BD SmartSite by BD Switzerland Sàrl in the FDA's device registry (GUDID). Together they are named in 568 adverse event reports in the FDA's MAUDE database, received between Jul 23, 2018 and Sep 18, 2026 — classified as 1 death, 3 injuries, 564 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (178 reports).

4 FDA recall records name at least one of these models by its device identifier, 3 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

BD SmartSite 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.

1. May 12, 2025Open, Classified

   Sterile, single use closed system drug transfer devices, standalone or on infusion sets or bonded syringes, may leak at the interface between the closed male luer component and the needle-free connector, which may cause procedure delay, treatment interruptions, exposure to hazardous drugs, and/or underdosing of medication.

   Z-1970-2025 · Root cause: Process control · names 2 of these models · Recall details · FDA record ↗

2. Oct 11, 2023Open, Classified

   Affected infusion sets labeled as free of DEHP actually do contain di(2-ethylhexyl) phthalate (DEHP).

   Z-0351-2024 · Root cause: Error in labeling · Recall details · FDA record ↗

3. Oct 11, 2023Open, Classified

   Affected infusion sets labeled as free of DEHP actually do contain di(2-ethylhexyl) phthalate (DEHP).

   Z-0350-2024 · Root cause: Error in labeling · names 2 of these models · Recall details · FDA record ↗

4. Feb 28, 2019Terminated

   Leaking of the Smartsite Syringe Administration Set. May result in delay or interruption of infusion, under-infusion, contamination of the fluid path and HCP exposure to infusates.

   Z-1210-2019 · Root cause: Process control · Recall details · FDA record ↗

Most reported BD SmartSite problems

BD SmartSite models

29 models, most reported first. Each model has its own page with its reports, recalls and device details.

• BD SmartSite 10014881

  Set, administration, intravascular
  175 reports
• BD SmartSite 70001B-07T

  Set, administration, intravascular
  2 recalls34 reports
• BD SmartSite 4030B-07T

  Set, administration, intravascular
  2 recalls6 reports
• BD SmartSite 10798696

  Set, administration, intravascular
  1 recall32 reports
• BD SmartSite 10010903

  Set, administration, intravascular
  1 death73 reports
• BD SmartSite 42081E

  Set, administration, intravascular
  1 recall14 reports
• BD SmartSite 2300E-0500

  Set, administration, intravascular
  35 reports
• BD SmartSite 42511E

  Set, administration, intravascular
  33 reports
• BD SmartSite 42502E

  Set, administration, intravascular
  21 reports
• BD SmartSite 11059728

  Set, administration, intravascular
  20 reports
• BD SmartSite 82113E

  Set, administration, intravascular
  17 reports
• BD SmartSite 10013364

  Set, administration, intravascular
  17 reports
• BD SmartSite 42405E-07

  Set, administration, intravascular
  15 reports
• BD SmartSite 42521E

  Set, administration, intravascular
  15 reports
• BD SmartSite C42014E-07

  Set, administration, intravascular
  11 reports
• BD SmartSite 10013365

  Set, administration, intravascular
  9 reports
• BD SmartSite 82115E

  Set, administration, intravascular
  6 reports
• BD SmartSite C42010E

  Set, administration, intravascular
  6 reports
• BD SmartSite CM42500E-07

  Set, i.V. Fluid transfer
  6 reports
• BD SmartSite 42519E

  Set, administration, intravascular
  5 reports
• BD SmartSite C42013E

  Set, administration, intravascular
  4 reports
• BD SmartSite 2309E

  Set, administration, intravascular
  3 reports
• BD SmartSite 10425228

  Set, administration, intravascular
  2 reports
• BD SmartSite 42503E

  Set, administration, intravascular
  2 reports
• BD SmartSite 42504E

  Set, administration, intravascular
  2 reports
• BD SmartSite CS42522E-07

  Set, administration, intravascular
  2 reports
• BD SmartSite 10050187

  Set, administration, intravascular
  1 report
• BD SmartSite 30843E

  Set, administration, intravascular
  1 report
• BD SmartSite 30916-07

  Set, administration, intravascular
  1 report

Recent BD SmartSite adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionSep 18, 2026Material Twisted/Bent

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50831246 ↗
• MalfunctionSep 18, 2026Air/Gas in Device

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50831237 ↗
• MalfunctionSep 18, 2026Material Twisted/Bent

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50831236 ↗
• MalfunctionSep 18, 2026Air/Gas in Device

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50831235 ↗
• MalfunctionSep 14, 2026Complete Blockage

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50763182 ↗
• MalfunctionAug 20, 2026Complete Blockage

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50355947 ↗
• MalfunctionAug 20, 2026Complete Blockage

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50355508 ↗
• MalfunctionJul 10, 2026Complete Blockage

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25786567 ↗
• MalfunctionJul 4, 2026Leak/Splash

  IT WAS REPORTED THAT BD SMARTSITE BURETTE SET WAS LEAKING THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM IT WAS REPORTED BY CUSTOMER THAT THE PRODUCT IS LEAKING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25710685 ↗
• MalfunctionJul 4, 2026Leak/Splash

  IT WAS REPORTED THAT BD SMARTSITE BURETTE SET WAS LEAKING. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM. IT WAS REPORTED BY CUSTOMER THAT THE PRODUCT IS LEAKING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25710683 ↗
• MalfunctionJun 15, 2026Leak/Splash

  IT WAS REPORTED THAT THE BD TEXIUM SECONDARY SET SMARTSITE NEEDLE-FREE VALVE BAG ACCESS PORT HAD LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: LEAKING AT GREEN TEXIUM BONDED SITE DURING ADMINISTRATION. ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER: WHAT WAS THE IMPACT TO THE PATIENT? INFUSION WAS SLIGHTLY DELAYED. A PHARMACY STAFF HAD TO COME IN OVERNIGHT TO REPLACE THE ADMINISTRATION LINE IN ORDER FOR PROPER INFUSION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25510773 ↗
• MalfunctionJun 9, 2026Leak/Splash; Material Separation

  IT WAS REPORTED THAT THE BD ALARIS SMARTSITE LOW SORBING SECONDARY SET HAD SEPARATED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE BD ALARIS PUMP INFUSION SET'S TUBING MAY SEPARATE, LEAK, OR FAIL TO PRIME. WHEN THIS OCCURS: TREATMENT WILL BE DELAYED. THERE IS POTENTIAL FOR PATIENT BLOOD LOSS. THE COMPROMISED ADMINISTRATION SET PRESENTS A ROUTE FOR INFECTIOUS AGENTS. MEDICATION MAY SPILL, POTENTIALLY EXPOSING STAFF AND PATIENTS TO TOXIC MEDICATION (E.G., CHEMOTHERAPY AGENTS). ALSO, THE SPILL MAY PRESENT A FALL RISK. MEDICATION MAY BE WASTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25449448 ↗
• MalfunctionMay 29, 2026Leak/Splash

  IT WAS REPORTED THAT THE BD TEXIUM SECONDARY SET SMARTSITE NEEDLE-FREE VALVE BAG ACCESS PORT HAD LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MANY REPORTS RECEIVED IN REGARDS TO BD LOW SORBING SECONDARY SET SMARTSITE NEEDLE-FREE VALVE BAG ACCESS PORT REF # 70001B-07T. 5 REPORTS TOTAL REPORTED IN TERMS OF LEAKING. ONE REPORT INVOLVED STARTING A PIGGYBACK INFUSION OF FLUOROURACIL 900MG, A LEAK OCCURRED AT THE CONNECTOR SITE TO THE PRIMARY IV LINE. APPROXIMATELY 5 ML OF FLUID LEAKED, BUT NONE CAME INTO CONTACT WITH THE PATIENT. THE LEAK WAS CONTAINED WITH A DISPOSABLE PAD. PHARMACY WAS NOTIFIED. SIMILAR EVENTS COULD OCCUR AT OTHER FACILITIES USING THE SAME BD LOW SORBING SECONDARY SET SMARTSITE NEEDLE-FREE VALVE BAG ACCESS PORT IF THERE ARE PRODUCT DEFECTS, COMPATIBILITY ISSUES, OR ASSEMBLY ERRORS. IF LEAKAGE OCCURS WITH HAZARDOUS DRUGS LIKE CHEMOTHERAPY, STAFF COULD BE EXPOSED TO CYTOTOXIC FLUIDS, PRESENTING HEALTH RISKS SUCH AS SKIN IRRITATION OR LONG-TERM EFFECTS. ADDITIONALLY, MEDICATION LOSS COULD LEAD TO UNDERDOSING, IMPACTING PATIENT CARE. DESCRIBE ANY PATIENT HARM, INJURY, COMPLICATION OR NEGATIVE OUTCOME THAT OCCURRED AS A RESULT OF THE EVENT. NEGA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25337618 ↗
• MalfunctionMay 29, 2026Leak/Splash

  IT WAS REPORTED THAT THE BD TEXIUM SECONDARY SET SMARTSITE NEEDLE-FREE VALVE BAG ACCESS PORT HAD LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MANY REPORTS RECEIVED IN REGARDS TO BD LOW SORBING SECONDARY SET SMARTSITE NEEDLE-FREE VALVE BAG ACCESS PORT REF # (B)(4). 5 REPORTS TOTAL REPORTED IN TERMS OF LEAKING. ONE REPORT INVOLVED STARTING A PIGGYBACK INFUSION OF FLUOROURACIL 900MG, A LEAK OCCURRED AT THE CONNECTOR SITE TO THE PRIMARY IV LINE. APPROXIMATELY 5 ML OF FLUID LEAKED, BUT NONE CAME INTO CONTACT WITH THE PATIENT. THE LEAK WAS CONTAINED WITH A DISPOSABLE PAD. PHARMACY WAS NOTIFIED. SIMILAR EVENTS COULD OCCUR AT OTHER FACILITIES USING THE SAME BD LOW SORBING SECONDARY SET SMARTSITE NEEDLE-FREE VALVE BAG ACCESS PORT IF THERE ARE PRODUCT DEFECTS, COMPATIBILITY ISSUES, OR ASSEMBLY ERRORS. IF LEAKAGE OCCURS WITH HAZARDOUS DRUGS LIKE CHEMOTHERAPY, STAFF COULD BE EXPOSED TO CYTOTOXIC FLUIDS, PRESENTING HEALTH RISKS SUCH AS SKIN IRRITATION OR LONG-TERM EFFECTS. ADDITIONALLY, MEDICATION LOSS COULD LEAD TO UNDERDOSING, IMPACTING PATIENT CARE. DESCRIBE ANY PATIENT HARM, INJURY, COMPLICATION OR NEGATIVE OUTCOME THAT OCCURRED AS A RESULT OF THE EVENT. NEGATIVE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25334942 ↗
• MalfunctionMay 22, 2026Complete Blockage

  IT WAS REPORTED THAT THE BD ALARIS SMARTSITE LOW SORBING SECONDARY SET WAS OCCLUDED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: I AM WRITING TO REPORT SEVERAL INCIDENTS WHERE THE DRUG IS NOW FLOWING THROUGH THE BD SMARTSITE LOW SORBING SECONDARY SET. REF 10014881.THE FLUID WILL PASS INTO THE DRIP CHAMBER BUT THEN IS UNABLE TO GO ANY FURTHER THROUGH THE TUBING. ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER: PLEASE CAN YOU CONFIRM WHAT MEDICATION WAS BEING ADMINISTERED? THE ISSUE OCCURRED WITH BOTH PACLITAXEL AND DOCETAXEL. PLEASE CAN YOU CONFIRM IF THE MEDICATION WAS STORED IN THE REFRIGERATOR? IF YES, WAS IT ALLOWED TO REACH ROOM TEMPERATURE BEFORE USE? IT WAS IN THE FRIDGE BUT RETURNED TO ROOM TEMPERATURE BEFORE TRY TO ADMINISTER. PLEASE CAN YOU CONFIRM THE MAKE AND MODEL OF THE CONNECTING PRODUCTS? EQUASHIELD CLOSED SYSTEM SPIKE WAS ATTACHED TO BD SMARTSITE LOW SORBING SECONDARY SET. PLEASE CAN YOU CONFIRM IF THERE ARE ANY VISIBLE DEFECTS TO THE DEVICE I.E., CRACKS, FLASHES, KINKS? THERE DO NOT APPEAR TO BE ANY VISIBLE DEFECTS. PLEASE CAN YOU CONFIRM IF THE CONNECTING PRODUCT HAS A LUER SLIP OR LUER LOCK CONNECTION? LUER PLEASE CONFIRM WHETHER THE FLOW WA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25263190 ↗

Other BD Switzerland Sàrl products

• Alaris, SmartSite160 models · 10,227 reports · 8 recalls
• Alaris85 models · 2,797 reports · 10 recalls
• MaxZero47 models · 2,377 reports
• MaxGuard49 models · 780 reports · 11 recalls
• BD PhaSeal23 models · 992 reports · 2 recalls
• MaxPlus18 models · 762 reports · 2 recalls
• Alaris, SmartSite, Texium12 models · 291 reports · 5 recalls
• BD PhaSeal Optima11 models · 474 reports · 1 recall