BD TexiumRecalls & reported problems across all models
BD Switzerland Sàrl · 7 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
2 open recalls name at least one BD Texium model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 211
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls
- 2
We found 7 models of BD Texium by BD Switzerland Sàrl in the FDA's device registry (GUDID). Together they are named in 211 adverse event reports in the FDA's MAUDE database, received between Jul 13, 2018 and Apr 22, 2026 — classified as 211 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (118 reports).
2 FDA recall records name at least one of these models by its device 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. 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
BD Texium 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.
- 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-1971-2025 · Root cause: Process control · names 6 of these models · Recall details · FDA record ↗
- 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 · Recall details · FDA record ↗
Most reported BD Texium problems
Device problems
- Leak/Splash118
- Fluid/Blood Leak43
- Break22
- Loose or Intermittent Connection9
- Device Contamination with Chemical or Other Material8
- Material Separation7
- Complete Blockage5
- Detachment of Device or Device Component5
Patient problems
- No Clinical Signs, Symptoms or Conditions137
- No Patient Involvement37
- No Consequences Or Impact To Patient30
- No Information6
- Insufficient Information5
- No Known Impact Or Consequence To Patient1
BD Texium models
7 models, most reported first. Each model has its own page with its reports, recalls and device details.
- BD Texium MY8060Syringe, piston1 recall94 reports
- BD Texium 40000-07TSet, administration, intravascular1 recall43 reports
- BD Texium MY8020Syringe, piston1 recall31 reports
- BD Texium MY8030Syringe, piston1 recall30 reports
- BD Texium MY8010Syringe, piston1 recall7 reports
- BD Texium MY8003Syringe, piston1 recall5 reports
- BD Texium MY8005Syringe, piston1 recall1 report
Recent BD Texium adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionApr 22, 2026Leak/Splash
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24960554 ↗MalfunctionApr 22, 2026Leak/Splash
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24960553 ↗MalfunctionMar 26, 2026Leak/Splash; Loose or Intermittent Connection
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24702423 ↗MalfunctionMar 26, 2026Leak/Splash; Loose or Intermittent Connection
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24702405 ↗MalfunctionMar 25, 2026Leak/Splash; Loose or Intermittent Connection
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24693926 ↗MalfunctionMar 25, 2026Leak/Splash; Loose or Intermittent Connection
IT WAS REPORTED THAT THE BD TEXIUM NEEDLE-FREE SYRINGE HAD CONNECTION ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: LEAKAGE OCCURS DURING CONNECTION AND/OR WHILE PUSHING DRUG INTO THE BAG. STAFF REPORT THE CONNECTION MAY NOT THREAD CORRECTLY WITH THE BAG ACCESS DEVICE. NOTABLY, WHEN THE TEXIUM SYRINGE IS SECURED/TIGHTENED FULLY, LEAKAGE APPEARS MORE LIKELY, AND SLIGHTLY LOOSENING MAY REDUCE LEAKAGE. LEAKAGE HAS OCCURRED WITH BOTH 20 ML AND 50 ML SIZES AND ACROSS DIFFERENT LOTS. DESCRIBE PATIENT / HCP / USER IMPACT: HAZARDOUS DRUG EXPOSURE, CHEMO LEAK
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24693923 ↗MalfunctionMar 25, 2026Leak/Splash; Loose or Intermittent Connection
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24693921 ↗MalfunctionMar 25, 2026Leak/Splash; Loose or Intermittent Connection
IT WAS REPORTED THAT THE BD TEXIUM NEEDLE-FREE SYRINGE HAD CONNECTION ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: LEAKAGE OCCURS DURING CONNECTION AND/OR WHILE PUSHING DRUG INTO THE BAG. STAFF REPORT THE CONNECTION MAY NOT THREAD CORRECTLY WITH THE BAG ACCESS DEVICE. NOTABLY, WHEN THE TEXIUM SYRINGE IS SECURED/TIGHTENED FULLY, LEAKAGE APPEARS MORE LIKELY, AND SLIGHTLY LOOSENING MAY REDUCE LEAKAGE. LEAKAGE HAS OCCURRED WITH BOTH 20 ML AND 50 ML SIZES AND ACROSS DIFFERENT LOTS. DESCRIBE PATIENT / HCP / USER IMPACT: HAZARDOUS DRUG EXPOSURE, CHEMO LEAK
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24693920 ↗MalfunctionMar 25, 2026Leak/Splash; Loose or Intermittent Connection
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24693915 ↗MalfunctionMar 25, 2026Leak/Splash; Loose or Intermittent Connection
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24693914 ↗MalfunctionMar 25, 2026Leak/Splash; Loose or Intermittent Connection
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24693913 ↗MalfunctionMar 19, 2026Complete Blockage
IT WAS REPORTED OCCLUSION WITH TEXIUM. ADDITIONAL INFORMATION. DELAY IN COMPOUNDING PROCESS, THIS SHORT TUBING SET WITH THE TEXIUM ACCESS WOULD NOT LET THE TECHNICIAN PUSH ANY DRUG THROUGH AND THEY HAD TO GET A NEW IV BAG AND TUBING SET TO FINISH THE PREP. NO PATIENT IMPACTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24641105 ↗MalfunctionJan 12, 2026Leak/Splash
IT WAS REPORTED THAT BD TEXIUM NEEDLE FREE SYRINGE WAS LEAKING. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM. IT WAS REPORTED BY CUSTOMER THAT DURING COMPOUNDING OF CHEMOTHERAPY MEDICATION WITH A 50 ML TEXIUM BONDED SYRINGE, THE LIQUID LEAKED OUT OF THE TIP WHERE IT CONNECTED TO THE SYRINGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24033149 ↗MalfunctionDec 23, 2025Complete Blockage; Complete Blockage
IT WAS REPORTED THAT BD TEXIUM NEEDLE FREE SYRINGE HAD FLOW ISSUES. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM IT WAS REPORTED BY CUSTOMER THAT THE TECHNICIAN WENT TO DRAW FLUID OUT OF A COUPLE ELAHERE VIALS. THE FIRST VIAL WENT FINE AND SHE WAS ABLE TO DRAW THE FLUID OUT AS ANTICIPATED. WHEN SHE WENT TO THE NEXT VIAL, SHE WAS NOT ABLE TO DRAW BACK ANY LIQUID FROM THAT VIAL WITH THIS 30 ML SYRINGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23876701 ↗MalfunctionNov 10, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED THAT BD TEXIUM NEEDLE FREE SYRINGE WAS LEAKING THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM. IT WAS REPORTED BY THE CUSTOMER THAT ANOTHER LEAK OCCURRED WHEN INITIATING THE BLEOMYCIN. THE MEDICATION WAS HUNG ON THE IV POLE AND CONNECTED TO THE SECONDARY Y-SITE HUB. RN NOTED THE MEDICATION DRIPPED IN THE CHAMBER, BUT THE PUMP HAD NOT YET STARTED. CLEAR LIQUID NOTED ON THE TEXIUM CONNECTOR BETWEEN THE GREEN AND WHITE MOLDED AREA.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23514201 ↗
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
- BD SmartSite29 models · 568 reports · 4 recalls
- Alaris, SmartSite, Texium12 models · 291 reports · 5 recalls
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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