Alaris 10012241-0500Recalls & reported problems

Summary

The FDA's MAUDE database contains 138 adverse event reports that list this exact device (DI 10885403221705), received between Aug 9, 2018 and May 12, 2026 — classified as 6 injuries, 132 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (88 reports).

1 FDA recall record name this device's identifier, 1 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.

Recalls naming this device

1. May 12, 2025Class IIOpen, 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-1973-2025 · Root cause: Process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 138 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 12, 2026Leak/Splash

  IT WAS REPORTED THAT THE BD TEXIUM CLOSED MALE LUER WITH FEMALE CAP HAD LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE RECENTLY HAD AN INPATIENT LEAK INVOLVING TEXIUM. A NURSE DISCONNECTED BETWEEN THE TEXIUM AND THE SMARTSITE, AND A CHEMOTHERAPY SPILL OCCURRED. WE ARE ALSO TRYING TO UNDERSTAND WHETHER THIS MAY BE RELATED TO THE MAX ZERO NEEDLELESS CONNECTORS, SINCE THEY ARE DESIGNED TO PUSH FLUID OUT AND WE TYPICALLY EXPECT TO SEE FLUID PRESENT AT THE ENDO F THE CONNECTOR WHEN IT'S NOT PART OF A CLOSED SYSTEM. ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER: KINDLY PROVIDE THE MATERIAL NUMBER AND BATCH/LOT NUMBER OF THE MAX ZERO NEEDLELESS CONNECTORS. I'LL INQUIRE. ANY ADVERSE EVENT OR SERIOUS INJURY REPORTED TO PATIENT OR HEALTHCARE PROFESSIONAL? IF YES, PLEASE PROVIDE THE DETAILS. NO. CAN YOU PLEASE PROVIDE AN EXACT DATE OF EVENT IN FORMAT DD-MMM-YYYY? 23-APRIL-2026.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25153514 ↗
• MalfunctionFeb 2, 2026Leak/Splash

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24239972 ↗
• MalfunctionNov 21, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT BD ALARIS CLOSED MALE LUER WAS LEAKING. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING: IT WAS REPORTED BY CUSTOMER THAT LEAKAGE FROM THE TIP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23624924 ↗
• MalfunctionNov 18, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE BD ALARIS CLOSED MALE LUER HAD LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE¿VE BEEN RECEIVING MULTIPLE REPORTS OF LEAKAGE FROM THE TEXIUM TIP AGAIN. ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER: WHAT WAS THE ISSUE YOU EXPERIENCED? LEAKAGE FROM THE TIP IMPACT OR CLINICAL EVENT THAT OCCURRED TO THE PATIENT, HEALTHCARE PROVIDER OR USER: THE PATIENT WOKE UP DUE TO LEAKAGE FROM THE TIP. SAFETY IMPACT WAS NOT MEASURED. COULDN¿T ESTIMATE THE AMOUNT OF LEAKAGE. BOTH SAFETY AND EFFICACY CONCERNS WITH LEAKAGE AND LESS DOSE ADMINISTRATION THAN INTENDED. ANY ADVERSE EVENT OR SERIOUS INJURY REPORTED TO PATIENT OR HEALTHCARE PROFESSIONAL? IF YES, PLEASE PROVIDE THE DETAILS. NOT ABLE TO ASSESS THE ADVERSE EVENTS OR SERIOUS HARM CAUSED BY ADMINISTERING LESS DOSE THAN INTENDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23578282 ↗
• MalfunctionNov 10, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT BD ALARIS CLOSED MALE LUER WAS LEAKING. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING: IT WAS REPORTED BY THE CUSTOMER THAT LEAKING OF MEDICATION NOTED AT THE CONNECTION SITE OF THE TEXIUM CONNECTOR TO THE WHITE HUB ON THE PRIMARY TEXIUM TUBING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23514005 ↗
• MalfunctionNov 10, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT BD ALARIS CLOSED MALE LUER WAS LEAKING. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM. IT WAS REPORTED BY THE CUSTOMER THAT GREEN TEXIUM TIP LEAKING AT THE CONNECTION SITE OF THE TUBING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23513868 ↗
• MalfunctionNov 10, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT BD ALARIS CLOSED MALE LUER WAS LEAKING. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM IT WAS REPORTED BY THE CUSTOMER THAT THE TEXIUM TIP OF THE SECONDARY TUBING STARTING TO LEAK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23513629 ↗
• MalfunctionNov 4, 2025Break; Break

  IT WAS REPORTED THAT THE BD ALARIS TEXIUM CLOSED MALE LUER WAS DAMAGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: TEXIUM BROKE OFF. TEXIUM CLOSED MALE LUER LOT (10)25025321 EXP 02-12-2028.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23468837 ↗
• MalfunctionOct 21, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT BD TEXIUM CLOSED MALE LUER CAP WAS LEAKING. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM IT WAS REPORTED BY CUSTOMER THAT THIS WAS A STAND ALONE TEXIUM OR WAS THIS A BONDED SET.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23349138 ↗
• MalfunctionOct 21, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT BD TEXIUM CLOSED MALE LUER SET WAS LEAKING. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM. IT WAS REPORTED BY THE CUSTOMER THAT THE BLUE ADAPTOR CAP WAS CRACKED AND LEAKING CHEMOTHERAPY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23347794 ↗
• MalfunctionOct 19, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT BD TEXIUM CLOSED MALE LUER WAS LEAKING . THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM. IT WAS REPORTED BY THE CUSTOMER THAT LEAKING FROM TIP DURING PREPARATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23334002 ↗
• MalfunctionOct 19, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT BD TEXIUM CLOSED MALE LUER CAP WAS LEAKING. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING: IT WAS REPORTED BY CUSTOMER THAT WHILE DOXIL WAS INFUSING PT NOTICED THERE WAS DOXIL LEAKING ON TOP OF THE PUMP AND SOME ON THE FLOOR. THE LEAK OCCURED AT THE Y SITE BY THE TEXIUM HUB.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23334001 ↗
• MalfunctionOct 19, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT BD ALARIS TEXIUM CLOSED MALE LUER WAS LEAKING. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING: IT WAS REPORTED BY CUSTOMER THAT THEY NOTICED THERE WERE 5-6 DROPS ON THE FLOOR AND THERE WAS LEAKAGE AROUND THE TEXIUM THAT WAS CONNECTED TO THE PRIMARY TUBING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23333976 ↗
• MalfunctionOct 19, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT BD TEXIUM CLOSED MALE LUER WAS LEAKING. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM: IT WAS REPORTED BY CUSTOMER THAT THE PATIENT'S 3RD DESENSITIZATION BAG OF OXALIPLATIN WAS LEAKING FROM THE TEXIUM CLOSED MALE LUER CAP. THE INFUSION WAS ALREADY FINISHING UP WHEN THIS WAS SEEN, INFUSION WAS STOPPED. THE NEXT BAG OF OXALIPLATIN WAS HUNG AND IT WAS NOTICED RIGHT AWAY THAT THE TEXIUM CAP WAS LEAKING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23333975 ↗
• MalfunctionOct 19, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT BD TEXIUM CLOSED MALE LUER CAP WAS LEAKING. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM. IT WAS REPORTED BY CUSTOMER THAT THEY WENT TO DISCONNECT PATIENT FROM INFUSION AND NOTICED SOME LIQUID ON THE FLOOR. DETERMINED IT WAS THE BENDEKA CHEMOTHERAPY INFUSION THAT WAS LEAKING FROM THE SECONDARY TUBING AT THE TEXIUM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23333974 ↗
• MalfunctionOct 19, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT BD TEXIUM MALE LUER CAP WAS LEAKING. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM: IT WAS REPORTED BY THE CUSTOMER THAT A COUPLE DROPS OF LIQUID ON THE FLOOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23333944 ↗
• MalfunctionOct 19, 2025Leak/Splash; Leak/Splash

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23333715 ↗
• MalfunctionOct 19, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT BD ALARIS CLOSED MALE LUER WAS LEAKING. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM: IT WAS REPORTED BY CUSTOMER THAT ITEM IS LEAKING.

  Patient problems: Insufficient Information

  MAUDE report 23333606 ↗
• MalfunctionOct 19, 2025Leak/Splash; Leak/Splash

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23333602 ↗
• MalfunctionOct 15, 2025Connection Problem; Connection Problem

  EVENT DETAILS: CUSTOMER IS STATING THAT TEXIUM CONNECTOR SKU# 10012241-0500 IS NOT LOCKING ONTO THEIR BD SYRINGES WITH A STRONG, POSITIVE FEEL. BASICALLY, THE CONNECTOR CAN TOO EASILY BE DISCONNECTED. THEY ARE CONCERNED THAT THIS COULD LEAD TO LEAKING AND EXPOSURE RISKS FOR STAFF AND PATIENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23304389 ↗
• MalfunctionOct 15, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE BD TEXIUM CLOSED MALE LUER WITH FEMALE CAP HAD LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: UMC LUBBOCK HAS EXPERIENCED SEVERAL TEXIUM LEAKS - STANDALONE AND BONDED - WHILE INFUSING CHEMO / HD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23296429 ↗
• MalfunctionOct 15, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE BD TEXIUM CLOSED MALE LUER WITH FEMALE CAP HAD LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: (B)(6) HAS EXPERIENCED SEVERAL TEXIUM LEAKS STANDALONE AND BONDED WHILE INFUSING CHEMO / HD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23295690 ↗
• MalfunctionOct 15, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE BD TEXIUM CLOSED MALE LUER WITH FEMALE CAP HAD LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: UMC LUBBOCK HAS EXPERIENCED SEVERAL TEXIUM LEAKS - STANDALONE AND BONDED - WHILE INFUSING CHEMO / HD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23295248 ↗
• MalfunctionOct 15, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE BD TEXIUM CLOSED MALE LUER WITH FEMALE CAP HAD LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: UMC LUBBOCK HAS EXPERIENCED SEVERAL TEXIUM LEAKS - STANDALONE AND BONDED - WHILE INFUSING CHEMO / HD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23294908 ↗
• MalfunctionOct 15, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE BD CLOSED MALE LUER HAD LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: UMC LUBBOCK HAS EXPERIENCED SEVERAL TEXIUM LEAKS - STANDALONE AND BONDED - WHILE INFUSING CHEMO / HD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23287407 ↗