AlarisRecalls & reported problems across all models
BD Switzerland Sàrl · 85 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
7 open recalls name at least one Alaris model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 2,797
- Deaths reported
- 3
- Injuries reported
- 110
- Recalls
- 10
We found 85 models of Alaris by BD Switzerland Sàrl in the FDA's device registry (GUDID). Together they are named in 2,797 adverse event reports in the FDA's MAUDE database, received between May 12, 2017 and Sep 29, 2026 — classified as 3 deaths, 110 injuries, 2,678 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (840 reports).
10 FDA recall records name at least one of these models by its device identifier, 7 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
Alaris 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.
- 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 · names 12 of these models · Recall details · FDA record ↗
- Sep 11, 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-0035-2026 · Root cause: Under Investigation by firm · names 3 of these models · 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 · names 4 of these models · Recall details · FDA record ↗
- 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 ↗
- 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-1970-2025 · Root cause: Process control · Recall details · FDA record ↗
- Oct 11, 2023Class IIOpen, 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 ↗
- Oct 11, 2023Class IIOpen, 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 · names 8 of these models · Recall details · FDA record ↗
- Apr 9, 2020Class IITerminated
The products have the potential to leak between the connection of the male luer and the yellow striped tubing. This leak may be observed while priming or during use. The most likely health consequence associated with a leak in an administration set would be inadequate pain control for the patient due to an under-infusion of medication.
Z-1968-2020 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
- Apr 9, 2020Class IITerminated
The products have the potential to leak between the connection of the male luer and the yellow striped tubing. This leak may be observed while priming or during use. The most likely health consequence associated with a leak in an administration set would be inadequate pain control for the patient due to an under-infusion of medication.
Z-1967-2020 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
- May 6, 2019Class ITerminated
An incomplete occlusion can be caused by a variation in the wall thickness of the pumping segment of the affected infusion sets used with the. The issue has the potential to lead to unintended delivery of medication when the pump module is not in running status or can result in faster than expected drug delivery flow when the pump is infusing.
Z-1770-2019 · Root cause: Nonconforming Material/Component · names 2 of these models · Recall details · FDA record ↗
Most reported Alaris problems
Device problems
- Fluid/Blood Leak840
- Leak/Splash745
- Complete Blockage347
- Material Separation265
- Break128
- Crack123
- Obstruction of Flow91
- Defective Component73
Patient problems
- No Clinical Signs, Symptoms or Conditions1,418
- No Consequences Or Impact To Patient825
- No Information197
- No Known Impact Or Consequence To Patient109
- No Patient Involvement98
- Insufficient Information70
- Inadequate Pain Relief53
- Chemical Exposure30
Alaris models
85 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Alaris 2202-0007Set, administration, intravascular3 recalls248 reports
- Alaris 2204-0007Set, administration, intravascular3 recalls59 reports
- Alaris 10010483Set, administration, intravascular3 recalls59 reports
- Alaris 30893-07Set, administration, intravascular1 recall152 reports
- Alaris 2260-0500Set, administration, intravascular2 recalls96 reports
- Alaris 10015414Set, administration, intravascular2 recalls96 reports
- Alaris 10013364TSet, administration, intravascular1 recall141 reports
- Alaris 10012241-0500Closed antineoplastic and hazardous drug reconstitution and transfer system1 recall138 reports
- Alaris 20129ESet, administration, intravascular188 reports
- Alaris 10011865Set, administration, intravascular1 death165 reports
- Alaris MS3500-15Set, i.V. Fluid transfer158 reports
- Alaris 10014914Set, administration, intravascular153 reports
- Alaris 11448964Set, administration, intravascular153 reports
- Alaris 10062818Set, administration, intravascular2 recalls34 reports
- Alaris 11426964Set, administration, intravascular2 recalls22 reports
- Alaris 2200-0500Set, administration, intravascular2 recalls17 reports
- Alaris 10013890Set, administration, intravascular2 recalls8 reports
- Alaris 10942011Set, administration, intravascular106 reports
- Alaris 2206-0007Set, administration, intravascular2 recalls1 report
- Alaris 10016073Set, i.V. Fluid transfer99 reports
- Alaris 72213NSet, administration, intravascular82 reports
- Alaris 2278-0500Set, administration, intravascular1 recall27 reports
- Alaris 2232-0007Set, administration, intravascular1 recall19 reports
- Alaris 30914Set, administration, intravascular58 reports
- Alaris 10012866Set, administration, intravascular54 reports
- Alaris 2203-0500Set, administration, intravascular1 recall2 reports
- Alaris 30873Set, administration, intravascular52 reports
- Alaris 10800177Set, administration, intravascular1 recall1 report
- Alaris 2210-0500Set, administration, intravascular1 recall0 reports
- Alaris 70000N-07Set, administration, intravascular1 recall0 reports
- Alaris 10863358Set, administration, intravascular1 recall0 reports
- Alaris 24201-0007Set, i.V. Fluid transfer1 recall0 reports
- Alaris 10800175Set, administration, intravascular48 reports
- Alaris 2430-0500Set, administration, intravascular36 reports
- Alaris 10010570Set, administration, intravascular26 reports
- Alaris 10014916Set, administration, intravascular24 reports
- Alaris 10015817Set, administration, intravascular1 death23 reports
- Alaris 10794983Set, administration, intravascular21 reports
- Alaris 72215NSet, i.V. Fluid transfer21 reports
- Alaris 11088483Set, administration, intravascular20 reports
- Alaris MS3500Set, administration, intravascular11 reports
- Alaris 10373772Set, administration, intravascular11 reports
- Alaris 10800173Set, administration, intravascular11 reports
- Alaris C25012Set, administration, intravascular10 reports
- Alaris 30853Set, administration, intravascular10 reports
- Alaris 10016242Set, administration, intravascular9 reports
- Alaris 10839681Set, administration, intravascular9 reports
- Alaris 30883Set, administration, intravascular9 reports
- Alaris 10011301Set, administration, intravascular8 reports
- Alaris 10012213Set, administration, intravascular8 reports
- Alaris C20025Set, administration, intravascular8 reports
- Alaris 10015612Set, administration, intravascular7 reports
- Alaris 82113Set, administration, intravascular5 reports
- Alaris C25006Set, administration, intravascular5 reports
- Alaris 11612593Set, administration, intravascular5 reports
- Alaris 20022Set, administration, intravascular4 reports
- Alaris 25206Set, administration, intravascular4 reports
- Alaris 10014918Set, administration, intravascular4 reports
- Alaris 10387509Set, administration, intravascular4 reports
- Alaris 10798703Set, administration, intravascular4 reports
- Alaris 30893Set, administration, intravascular4 reports
- Alaris 10241342Set, administration, intravascular3 reports
- Alaris 10800176Set, administration, intravascular3 reports
- Alaris 11582774Set, administration, intravascular3 reports
- Alaris C20022Set, administration, intravascular3 reports
- Alaris 2207-0007Set, administration, intravascular3 reports
- Alaris 2280-0000Set, administration, intravascular2 reports
- Alaris 25203Set, administration, intravascular2 reports
- Alaris 10014081Set, administration, intravascular2 reports
- Alaris 10014917Set, administration, intravascular2 reports
- Alaris 30862-0500Set, administration, intravascular2 reports
- Alaris C70101Set, administration, intravascular2 reports
- Alaris 30822Set, administration, intravascular1 report
- Alaris 10010761Set, administration, intravascular1 report
- Alaris 2202-0500Set, administration, intravascular1 report
- Alaris C24117Set, administration, intravascular1 report
- Alaris 2942-0500Set, administration, intravascular1 report
- Alaris 25205Set, administration, intravascular1 report
- Alaris 30910Set, administration, intravascular1 report
- Alaris 70200Set, administration, intravascular1 report
- Alaris 10010985Set, administration, intravascular1 report
- Alaris 10031776Set, administration, intravascular1 death1 report
- Alaris 10321214Set, administration, intravascular1 report
- Alaris C30006Set, administration, intravascular1 report
- Alaris 11608375Set, administration, intravascular1 report
Recent Alaris adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 29, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50935986 ↗MalfunctionSep 29, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50935982 ↗MalfunctionSep 29, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50935981 ↗MalfunctionSep 29, 2026Break
It was reported that the BD Alaris Extension Set had damaged tubing. The following information was provided by the initial reporter: We are still experiencing tubing that is ¿breaking.¿ Our clinical staff in CW has most recently reported the following: 4 Extension Set: UMID 1609 MFG# 11088483Additional Information Received from the Customer:Was the fault observed before priming, during priming or after priming the set? Most are after priming and standard use, some occur during primingPlease confirm the exact location of the reported fault within the set? At the Leur connection Did it fall apart at where the tubing connects? YesWhat was the impact to the patient? Loss of drug; risk of infectionCan you please provide an exact date of event in format dd-mmm-yyyy? Too many dates to provide. Risk reports were createdCan you please provide the Lot number associated with reported issue? I do not have specific Lot numbers as this has occurred over a several month period and the packaging has been thrown out as part of setting up the tubing.Can you please confirm all 4 Extension Set involve same patient or different patients? Different patients
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50935980 ↗MalfunctionSep 29, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50935975 ↗MalfunctionSep 29, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50935974 ↗MalfunctionSep 29, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50934067 ↗MalfunctionSep 29, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50933782 ↗MalfunctionSep 29, 2026Break
It was reported that the BD Alaris Microbore Extension Set had damaged tubing. The following information was provided by the initial reporter: We are still experiencing tubing that is ¿breaking.¿ Our clinical staff in CW has most recently reported the following: 4 Bi Fuse: UMID 5371, MFG#: 10794983.Additional Information Received from the Customer: Was the fault observed before priming, during priming or after priming the set? Most are after priming and standard usePlease confirm the exact location of the reported fault within the set? At the Leur connection Did it fall apart at where the tubing connects? Yes.What was the impact to the patient? Loss of drug; risk of infection.Can you please provide an exact date of event in format dd-mmm-yyyy? Too many dates to provide. Risk reports were created.Can you please provide the Lot number associated with reported issue? I do not have specific Lot numbers as this has occurred over a several month period and the packaging has been thrown out as part of setting up the tubing.Can you please confirm all 4 Bi Fuse involve same patient or different patients? Different patients.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50933776 ↗MalfunctionSep 29, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50933775 ↗MalfunctionSep 28, 2026Insufficient Flow or Under Infusion
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50926167 ↗MalfunctionSep 28, 2026Problem with Sterilization
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50924401 ↗MalfunctionSep 28, 2026Complete 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 the secondary tubing that did not infuse medication from the bag.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50917199 ↗MalfunctionSep 24, 2026Leak/Splash
It was reported that the BD Alaris Microbore Extension Set had leakage.The following information was provided by the initial reporter: Leaking extension set.Additional Information Received from the Customer:When was this defect observed? during or before use? During use.Can you please provide the Material number associated with reported issue? The material number was item number 10794983.Can you please provide the Lot number associated with reported issue? I do not have the Lot number.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50889058 ↗MalfunctionSep 22, 2026Excess Flow or Over-Infusion
It was reported that the BD Alaris Pump Module Infusion Set had flow issues. The following information was provided by the initial reporter: Incident Report Details: Device: BD Alaris 8015 PC Unit. Serial Number: (b)(6). Date of Event: 29-Aug-2026. Time of Event: Unknown. Patient Involvement: Yes. Patient Harm: Unknown. Event Description: The BD Alaris 8015 PC Unit (S/N (b)(6)) was infusing medication to a patient. The customer reported that the medication was delivered faster than expected. The infusion was programmed to run over 1 hour, however, the infusion was reportedly completed in approximately 38 minutes. No additional information regarding the infusion setup, medication, programmed rate, volume to be infused (VTBI), alarm history, or device logs was provided at the time of reporting.
Patient problems: Headache
MAUDE report 50858507 ↗
Other BD Switzerland Sàrl products
- Alaris, SmartSite160 models · 10,227 reports · 8 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
- BD PhaSeal Optima11 models · 474 reports · 1 recall
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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