Alaris 2260-0500Recalls & reported problems

Summary

The FDA's MAUDE database contains 96 adverse event reports that list this exact device (DI 07613203012591), received between May 12, 2017 and Sep 17, 2026 — classified as 5 injuries, 91 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (33 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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Aug 19, 2026Open, 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 · FDA record ↗

2. Oct 11, 2023Open, Classified

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

   Z-0349-2024 · Root cause: Error in labeling · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 96 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 17, 2026Patient-Device Incompatibility

  It was reported that BD alaris smartsite pump infusion set had connection issues.The following information was received by the initial reporter with the following Verbatim.It was reported by customer that IV tubing not staying spiked in bag.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50797366 ↗
• MalfunctionSep 17, 2026Patient-Device Incompatibility

  It was reported that BD alaris smartsite pump infusion set had connection issuesThe following information was received by the initial reporter with the following VerbatimIt was reported by customer that IV tubing not staying spiked in bag.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50797365 ↗
• MalfunctionJun 18, 2026Material Separation

  IT WAS REPORTED THAT THE BD ALARIS PUMP INFUSION SET HAD SEPARATED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: BEDSIDE RN WAS INFUSING IVIG FOR PATIENT. RN REMOVED IV SET FROM PUMP TO TAP OUT AIR THAT HAD ACCUMULATED IN THE LINE. UPON TAPPING, THE SOFTER PART OF THE TUBING, THE PART THAT GOES INTO THE CHANNEL, BROKE OFF FROM THE REST OF THE LINE. PRODUCT: BD ALARIS PUMP INFUSION LOW SORBING TUBING. VMID: AL2260-0500. NUMBER OF DEFECTIVE PRODUCT(S): 1.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25553875 ↗
• MalfunctionJun 5, 2026Leak/Splash

  IT WAS REPORTED THAT THE BD ALARIS PUMP INFUSION SET HAD LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PATIENT WAS TO RECEIVE INTRAVENOUS (IV) PROPOFOL FOR SEDATION DURING HD LINE INSERTION. PROPOFOL TUBING PRIMED BY CLINICAL STAFF. PROPOFOL WAS FOUND LEAKING FROM IV TUBING. IV TUBING HELD FOR INSPECTION. NEW PROPOFOL LINE AND TUBING INITIATED FOR PATIENT PROCEDURE. ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER: KINDLY PROVIDE THE BATCH/LOT NUMBER OF THE PRODUCT. 304387 DESCRIBE ANY PATIENT HARM, INJURY, COMPLICATION OR NEGATIVE OUTCOME THAT OCCURRED AS A RESULT OF THE EVENT. PATIENT OUTCOME: MILD HARM REPORTED. WHAT MEDICATION WAS BEING ADMINISTERED AND LEAKED. WAS THIS A CHEMOTHERAPY DRUG? MEDICATION INVOLVED: PROPOFOL (NON-CHEMOTHERAPY).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25417668 ↗
• MalfunctionFeb 2, 2026Leak/Splash; Separation Problem

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24238118 ↗
• MalfunctionJan 6, 2026Improper Flow or Infusion

  IT WAS REPORTED THAT BD ALARIS PUMP INFUSION SET HAD FLOW ISSUES THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM CUSTOMER IS A NEW BD ALARIS INFUSION SYSTEM IMPLEMENTATION. THE CANCER CENTER WENT LIVE WITH NEW PCU AND PUMP MODULES ON (B)(6) 2025. RN NOTED WHEN LOADING BD ALARIS LOW-SORB TUBING (REF# 2260-0500), THE PUMP MODULE DISPLAYED A CHECKING LINE MESSAGE ACROSS SCROLLING MESSAGE DISPLAY. RN CHECKED TUBING INSTALLATION, FOR ANY CLAMPED AREAS OF TUBING INCLUDING PINCHED TUBING, ROLLER OR PINCH CLAMPS AND RELOADED TUBING INTO PUMP MODULE. RN COULD NOT RESOLVE ALARM SO SHE PLACED LOW SORB TUBING INFUSION INTO A DIFFERENT PUMP MODULE AND THE INFUSION RAN WITH NO PROBLEMS. PRIMARY (NON-LOW-SORB) TUBING WAS LOADED INTO AFFECTED PUMP MODULES AND HAD NO ALARMS OR ISSUES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23981446 ↗
• MalfunctionNov 11, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT BD ALARIS PUMP INFUSION SET WAS SEPARATED. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING: IT WAS REPORTED BY A CUSTOMER THAT AFTER PUTTING TUBING INTO CHANNEL, ONCE DOOR WAS CLOSED, ALARM SOUNDED. RN ASSESSED SAFETY CLAMP AND NOTICED THE WHITE PART OF THE CLAMP HAD COME UNTHREADED FROM BLUE PART OF SAFETY CLAMP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23529094 ↗
• MalfunctionSep 2, 2025Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  IT WAS REPORTED THAT BD ALARIS PUMP INFUSION SET HAD FLOW ISSUES THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM IT WAS REPORTED BY CUSTOMER THAT "OVERINFUSION".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22935468 ↗
• MalfunctionAug 18, 2025Device Contamination with Chemical or Other Material; Manufacturing, Packaging or Shipping Problem

  STRING OF LINT IN SEALED TUBING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22827293 ↗
• MalfunctionAug 13, 2025Free or Unrestricted Flow; Free or Unrestricted Flow

  IT WAS REPORTED THAT BD ALARIS SMARTSITE PUMP INFUSION SET HAD FLOW ISSUES THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIMIT WAS REPORTED BY CUSTOMER THAT THEY HAVE SOME OCCASIONAL FLOW ISSUES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22795121 ↗
• MalfunctionJul 24, 2025Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT BD ALARIS 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 SPIKED ALBUMIN UNABLE TO FILL LINE EVEN WITH VENT OPEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22599932 ↗
• MalfunctionJul 24, 2025Partial Blockage; Partial Blockage

  IT WAS REPORTED THAT BD ALARIS PUMP INFUSION SET HAD FLOW ISSUES. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM IT WAS REPORTED BY CUSTOMER THAT THE SPIKED ALBUMIN UNABLE TO FILL LINE EVEN WITH VENT OPEN. ONLY WITH FULL FORCE PRESSING INTO RUBBER STOPPER DID ALBUMIN START TO FILL AND STOPPED WHEN PRESSURE RELEASED. AFTER FILLING THE LINE HALFWAY, IT STARTED TO FILL AS NORMAL AND HAD NO FURTHER ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22598401 ↗
• MalfunctionJul 8, 2025Break; Break

  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 CUSTOMER THAT "TREND OF A SPECIFIC BREAKAGE POINT ON SOME TUBING SETS"

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22436914 ↗
• MalfunctionMay 20, 2025Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT BD PUMP ALARIS INFUSION SET HAD FLOW ISSUES. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM IT WAS REPORTED BY CUSTOMER THAT TUBING WOULD NOT PRIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22054876 ↗
• MalfunctionMay 17, 2025Break; Break

  IT WAS REPORTED THAT BD ALARIS PUMP INFUSION SET WAS BROKEN. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM IT WAS REPORTED BY THE CUSTOMER THAT THE PART BELOW THE SPIKE BROKE OFF ON HIS ALARIS PUMP

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22041223 ↗
• MalfunctionOct 2, 2024Break; Break

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20351551 ↗
• MalfunctionSep 11, 2024

  IVIG TUBING VERY HARD TO PRIME. HAVE HAD THIS HAPPEN MULTIPLE TIMES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20189312 ↗
• MalfunctionAug 29, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT BD ALARIS PUMP MODULE LOW SORBING SET WAS LEAKING THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM: PART# 2260-0500 LOT# (10)24015065 LOW SORBING INFUSION SET HAD LEAKING TUBING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20104106 ↗
• MalfunctionAug 9, 2024Defective Component; Defective Component

  IT WAS REPORTED THAT BD ALARIS PUMP MODULE LOW SORBING SET WAS BROKEN. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM IT WAS REPORTED BY THE CUSTOMER THAT LOW SORBING IV TUBING SPIKE BROKE WHILE SPIKING A BAG OF IV HEPARIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19955479 ↗
• MalfunctionAug 7, 2024Infusion or Flow Problem; Infusion or Flow Problem

  NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 19927509 ↗
• MalfunctionApr 28, 2024Component Missing; Component Missing

  NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19199083 ↗
• InjurySep 21, 2023Defective Component; Defective Component

  IT WAS REPORTED THAT BD ALARIS PUMP  MODULE LOW SORBING SET SAFETY CLAMP FAILED CAUSING HYPOTENSION AND THE NEED FOR MEDICAL INTERVENTION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: COMPLAINT CATEGORY: FAIL TO FUNCTION / DEFECTIVE. SAFETY CLAMP HAD FAILED THAT WAS PREVIOUSLY INFUSING PROPOFOL VIA PERIPHERAL IV FAILED AND PT. ACCIDENTLY GOT A PROPOFOL BOLUS. 1ST CUSTOMER RESPONSE: ¿ ARE YOU ABLE TO PROVIDE THE BATCH NUMBER? NO¿THAT INFORMATION IS NOT AVAILABLE. ¿ WAS THERE A DELAY OF, OR CHANGE IN, THE COURSE OF TREATMENT DUE TO THE EVENT? NO. ¿ WAS THERE DAMAGE/BREAK ON THE CLAMP? NO. ¿ WAS THERE AN ALARIS PUMP AND PUMP MODULE IN USE AT THE TIME OF THE EVENT? YES. IF SO, WHAT PUMP MODULE MODEL WAS IN USE (8100, 8110, 8120)? 8100. ADD INFO FROM DISTRIBUTOR: 1. WAS THERE ANY INJURY /ADVERSE EFFECT TO THE PATIENT THAT REQUIRED ADDITIONAL MEDICAL CARE DUE TO THE REPORTED ISSUE BELOW? YES, PATIENT¿S BLOOD PRESSURE DECREASED BELOW GOAL. IF YES: WHAT WAS THE INJURY / ADVERSE EFFECT? DROP IN BLOOD PRESSURE. WHAT TYPE OF TREATMENT WAS PROVIDED? INCREASED FLOW RATE OF LEVOPHED INFUSION FROM 6 TO 8 MCG/MIN. HOW IS THE PATIENT DOING NOW? STABLE. WAS THERE ANY MEDICATION PR

  Patient problems: Low Blood Pressure/ Hypotension

  MAUDE report 17795561 ↗
• MalfunctionAug 29, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT BD ALARIS PUMP  MODULE LOW SORBING SET WAS LEAKING AND FOUND TO HAVE PINHOLES UPON INSPECTION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DURING EVENING ROUNDS RN WENT TO CHECK ON TUBING AND FOUND IT WAS LEAKING FENTYNAL. CONTACT PULLED THE TUBING AND RAN SALINE TO FIND ISSUE, LITTLE PIN HOLES HAD DEVELOPED. CONTACT SAID IT HAS BEEN AN ONGOING ISSUE BUT THAT THIS WAS THE FIRST TIME HER SAFETY TEAM HAD BEEN MADE AWARE.

  Patient problems: Insufficient Information

  MAUDE report 17647291 ↗
• MalfunctionAug 2, 2023Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT THE BD ALARIS PUMP MODULE LOW SORBING SET EXPERIENCED OCCLUSION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: I WAS ROUNDING AT LONG¿S PEAK HOSPITAL AND WAS TOLD BY BIRTH UNIT NURSES THAT THEY ARE EXPERIENCING MORE PATIENT SIDE OCCLUSION ALARMS WITH LOW SORBING TUBING WHEN ADMINISTERING OXYTOCIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17445987 ↗
• MalfunctionApr 3, 2023Material Puncture/Hole; Air/Gas in Device; Material Puncture/Hole; Air/Gas in Device

  IT WAS REPORTED WHILE USING BD ALARIS PUMP MODULE LOW SORBING SET DAMAGED TUBING LED TO AIR IN THE LINE AND LEAKAGE. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: REPORTED ISSUE PER CUSTOMER: "THE TPN TUBING WHAT NOT FULLY SEATED IN THE ALARIS PUMP AT THE TOP. I OPENED THE PUMP AND PULLED A BIT ON THE TUBING TO RESEAT THE TUBING CORRECTLY....SUDDENLY APROX 10MLS OF AIR WAS PULLED INTO THE TUBING -- A HOLE WAS NOTED JUST BELOW THE BLUE PEICE OF THE TUBING THAT I WAS TRYING TO RESEAT. I CLAMPED THE LINE IMMEDIATELY AND REPLACED THE TUBING. TEAM MADE AWARE - UNSURE IF THIS HOLE OCCURRED IN THE MOMENT OF THE AIR BEING SUCKED IN, OR IF THERE WAS A SMALL HOLE THAT WAS HELD CLOSED BY THE ALARIS PUMP AND THEN WHEN I MOVED THE TUBING, IT BECAME EVIDENT. WE DECIDED TO MONITOR TO INFECTION RELATED TO THE POTENTIAL OR PICC CONTAMINATION..TEAM DID NOT WANT TO PULL PICC UNLESS SIGNS OF INCREASED INFECTION. " ADDITIONAL INFO PROVIDED 03/21 ¿ COULD YOU POSSIBLY PROVIDE THE LOT NUMBER FOR THE PRODUCT? NO, I WAS ONLY PROVIDED THE TUBING. THE PACKAGING WAS NOT AVAILABLE FROM ICU STAFF. ¿ IS THE SAMPLE CHEMO CONTAMINATED? NO, CHEMO WAS NOT INVOL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16665501 ↗