Alaris, SmartSiteRecalls & reported problems across all models
BD Switzerland Sàrl · 160 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
7 open recalls name at least one Alaris, SmartSite model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 10,227
- Deaths reported
- 17
- Injuries reported
- 164
- Recalls
- 8
We found 160 models of Alaris, SmartSite by BD Switzerland Sàrl in the FDA's device registry (GUDID). Together they are named in 10,227 adverse event reports in the FDA's MAUDE database, received between Mar 9, 2016 and Sep 30, 2026 — classified as 17 deaths, 164 injuries, 10,043 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (2,956 reports).
8 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, 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.
- 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 · names 27 of these models · Recall details · FDA record ↗
- Sep 11, 2025Open, 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 11 of these models · Recall details · FDA record ↗
- Jul 8, 2025Open, 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 18 of these models · Recall details · FDA record ↗
- Apr 18, 2024Open, Classified
Due to infusion set tubing drip chamber becoming detached from the tubing potentially causing delays in treatment, or unintentionally exposing users to harsh infusates.
Z-1944-2024 · Root cause: Process control · Recall details · FDA record ↗
- 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 · names 2 of these models · Recall details · FDA record ↗
- 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 · names 18 of these models · Recall details · FDA record ↗
- Aug 2, 2021Open, Classified
Needle-free connector valves, either standalone or attached to extension sets, may have issues including difficulty to flush, flow issues, and partial or total occlusions, which could lead to therapy delay. Follow-up activates not required if product has already been used or was safely connected to the female luer of connecting device.
Z-2454-2021 · Root cause: Process control · Recall details · FDA record ↗
- May 6, 2019Terminated
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 21 of these models · Recall details · FDA record ↗
Most reported Alaris, SmartSite problems
Device problems
- Leak/Splash2,956
- Fluid/Blood Leak1,564
- Material Separation1,343
- Complete Blockage1,242
- Break543
- Restricted Flow rate441
- Backflow340
- Infusion or Flow Problem302
Patient problems
- No Clinical Signs, Symptoms or Conditions5,955
- No Consequences Or Impact To Patient2,649
- No Information621
- No Patient Involvement468
- Insufficient Information266
- No Known Impact Or Consequence To Patient244
- Chemical Exposure43
- Low Blood Pressure/ Hypotension28
Alaris, SmartSite models
160 models, 100 per page, most reported first. Each model has its own page with its reports, recalls and device details.
- Alaris, SmartSite 2420-0007Set, administration, intravascular1 recall4 deaths2,509 reports
- Alaris, SmartSite 2426-0007Set, administration, intravascular1 recall5 deaths1,401 reports
- Alaris, SmartSite 2426-0500Set, administration, intravascular2 recalls4 deaths753 reports
- Alaris, SmartSite 2420-0500Set, administration, intravascular2 recalls1 death642 reports
- Alaris, SmartSite 2000ESet, administration, intravascular1 death496 reports
- Alaris, SmartSite 11532269Set, administration, intravascular3 recalls332 reports
- Alaris, SmartSite 10010454Set, administration, intravascular4 recalls212 reports
- Alaris, SmartSite 2477-0007Set, administration, intravascular2 recalls295 reports
- Alaris, SmartSite 10010453Set, administration, intravascular4 recalls165 reports
- Alaris, SmartSite 2432-0007Set, administration, intravascular2 recalls256 reports
- Alaris, SmartSite 10013902Set, administration, intravascular1 recall234 reports
- Alaris, SmartSite 11171447Set, administration, intravascular4 recalls77 reports
- Alaris, SmartSite 20039ESet, administration, intravascular247 reports
- Alaris, SmartSite 10015012Set, administration, intravascular3 recalls87 reports
- Alaris, SmartSite 11522558Set, administration, intravascular2 recalls124 reports
- Alaris, SmartSite 2441-0007Set, administration, intravascular2 recalls97 reports
- Alaris, SmartSite 2465-0007Set, administration, intravascular3 recalls45 reports
- Alaris, SmartSite 10013072Set, administration, intravascular3 recalls33 reports
- Alaris, SmartSite 20027ESet, i.V. Fluid transfer1 death183 reports
- Alaris, SmartSite 10015861ASet, administration, intravascular2 recalls80 reports
- Alaris, SmartSite 20350ESet, administration, intravascular170 reports
- Alaris, SmartSite 2203ESet, i.V. Fluid transfer157 reports
- Alaris, SmartSite 2423-0007Set, administration, intravascular2 recalls48 reports
- Alaris, SmartSite 20019ESet, administration, intravascular1 recall97 reports
- Alaris, SmartSite 11426965Set, administration, intravascular2 recalls31 reports
- Alaris, SmartSite 10015862Set, administration, intravascular2 recalls21 reports
- Alaris, SmartSite 24600-0007Set, administration, intravascular2 recalls19 reports
- Alaris, SmartSite 10012144Set, administration, intravascular2 recalls18 reports
- Alaris, SmartSite 10813621Set, administration, intravascular2 recalls11 reports
- Alaris, SmartSite 10013361Set, administration, intravascular2 recalls9 reports
- Alaris, SmartSite 10821753Set, administration, intravascular2 recalls5 reports
- Alaris, SmartSite 10561554Set, administration, intravascular2 recalls4 reports
- Alaris, SmartSite 11404930Set, administration, intravascular2 recalls2 reports
- Alaris, SmartSite 24001-0007Set, administration, intravascular2 recalls2 reports
- Alaris, SmartSite 2466-0007Set, administration, intravascular2 recalls1 report
- Alaris, SmartSite 2403-0007Set, administration, intravascular2 recalls1 report
- Alaris, SmartSite 11419365Set, administration, intravascular2 recalls1 report
- Alaris, SmartSite 11613191Set, administration, intravascular2 recalls0 reports
- Alaris, SmartSite 10802688Set, administration, intravascular96 reports
- Alaris, SmartSite 0.0022003Set, administration, intravascular88 reports
- Alaris, SmartSite 2429-0500Set, administration, intravascular1 recall35 reports
- Alaris, SmartSite 20059ESet, administration, intravascular84 reports
- Alaris, SmartSite 11607704Set, administration, intravascular1 recall32 reports
- Alaris, SmartSite 2434-0007Set, administration, intravascular1 recall30 reports
- Alaris, SmartSite C24101ESet, administration, intravascular1 recall30 reports
- Alaris, SmartSite 2452-0007Set, administration, intravascular1 recall24 reports
- Alaris, SmartSite 20159ESet, administration, intravascular69 reports
- Alaris, SmartSite 2478-0000Set, administration, intravascular1 recall19 reports
- Alaris, SmartSite 47177ESet, administration, intravascular65 reports
- Alaris, SmartSite 10933805Set, administration, intravascular1 recall12 reports
- Alaris, SmartSite 10015896Set, administration, intravascular1 recall8 reports
- Alaris, SmartSite 2447-0007Set, administration, intravascular1 recall7 reports
- Alaris, SmartSite 20062ESet, administration, intravascular1 recall5 reports
- Alaris, SmartSite 10015645Set, administration, intravascular1 recall5 reports
- Alaris, SmartSite 2410-0500Set, administration, intravascular1 recall4 reports
- Alaris, SmartSite 20127ESet, administration, intravascular54 reports
- Alaris, SmartSite 10012645Set, administration, intravascular1 recall4 reports
- Alaris, SmartSite 10013034Set, administration, intravascular1 recall3 reports
- Alaris, SmartSite 2450-0500Set, administration, intravascular1 recall3 reports
- Alaris, SmartSite 2421-0500Set, administration, intravascular1 recall2 reports
- Alaris, SmartSite 10013186Set, administration, intravascular1 recall2 reports
- Alaris, SmartSite 10015294Set, administration, intravascular1 recall2 reports
- Alaris, SmartSite 10013037Set, administration, intravascular1 recall2 reports
- Alaris, SmartSite 2455-0500Set, administration, intravascular1 recall1 report
- Alaris, SmartSite 2433-0007Set, administration, intravascular1 recall1 report
- Alaris, SmartSite C24116ESet, administration, intravascular1 recall0 reports
- Alaris, SmartSite 2428-0007Set, administration, intravascular1 recall0 reports
- Alaris, SmartSite 2411-0500Set, administration, intravascular1 recall0 reports
- Alaris, SmartSite 2419-0007Set, administration, intravascular1 recall0 reports
- Alaris, SmartSite 2408-0500Set, administration, intravascular1 recall0 reports
- Alaris, SmartSite 11582773Set, administration, intravascular1 recall0 reports
- Alaris, SmartSite 20028ESet, administration, intravascular48 reports
- Alaris, SmartSite 37262ESet, administration, intravascular44 reports
- Alaris, SmartSite 20041ESet, administration, intravascular40 reports
- Alaris, SmartSite 20038ESet, administration, intravascular38 reports
- Alaris, SmartSite 20029ESet, administration, intravascular36 reports
- Alaris, SmartSite 20128ESet, administration, intravascular34 reports
- Alaris, SmartSite 20043ESet, administration, intravascular25 reports
- Alaris, SmartSite 30204ESet, administration, intravascular22 reports
- Alaris, SmartSite 42103E-07Set, administration, intravascular20 reports
- Alaris, SmartSite 10012564Set, administration, intravascular20 reports
- Alaris, SmartSite 41173ESet, administration, intravascular1 death18 reports
- Alaris, SmartSite 30262ESet, administration, intravascular13 reports
- Alaris, SmartSite 47233ESet, administration, intravascular13 reports
- Alaris, SmartSite 20051ESet, administration, intravascular12 reports
- Alaris, SmartSite 2000EASet, administration, intravascular12 reports
- Alaris, SmartSite 42493ESet, administration, intravascular11 reports
- Alaris, SmartSite 0.00421Set, administration, intravascular10 reports
- Alaris, SmartSite 30207ESet, administration, intravascular9 reports
- Alaris, SmartSite C24103ESet, administration, intravascular9 reports
- Alaris, SmartSite 11590100Set, administration, intravascular9 reports
- Alaris, SmartSite 11287205Set, administration, intravascular8 reports
- Alaris, SmartSite 10927766Set, administration, intravascular8 reports
- Alaris, SmartSite 10012283Set, administration, intravascular8 reports
- Alaris, SmartSite 10053857Set, administration, intravascular8 reports
- Alaris, SmartSite 42434ESet, administration, intravascular8 reports
- Alaris, SmartSite 10037032Set, administration, intravascular8 reports
- Alaris, SmartSite 42290ESet, i.V. Fluid transfer7 reports
- Alaris, SmartSite 10015489Set, administration, intravascular7 reports
- Alaris, SmartSite 11484001Set, administration, intravascular7 reports
Recent Alaris, SmartSite adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Material Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50950937 ↗MalfunctionSep 30, 2026Material Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50950933 ↗MalfunctionSep 30, 2026Material Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50950928 ↗MalfunctionSep 30, 2026Material Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50950927 ↗MalfunctionSep 30, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50950577 ↗MalfunctionSep 30, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50949386 ↗MalfunctionSep 30, 2026Break
It was reported that BD alaris smartsite pump infusion set was damaged.The following information was received by the initial reporter with the following Verbatim.It was reported by customer that experiencing tubing that is ¿breaking."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50949385 ↗MalfunctionSep 29, 2026Leak/Splash
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50938130 ↗MalfunctionSep 29, 2026Material Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50937958 ↗MalfunctionSep 29, 2026Complete Blockage
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50936980 ↗MalfunctionSep 29, 2026Material Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50936979 ↗MalfunctionSep 29, 2026Material Puncture/Hole
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50936977 ↗MalfunctionSep 28, 2026Air/Gas in Device
It was reported that BD alaris smartsite pump infusion set had air in line.The following information was received by the initial reporter with the following Verbatim.It was reported by customer that failure to alarm for air-in-line.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50917203 ↗MalfunctionSep 28, 2026Leak/Splash
It was reported that BD alaris smartsite pump infusion set was leaking.The following information was received by the initial reporter with the following Verbatim.It was reported by customer that the tubing that have leaked at the filter when priming.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50917197 ↗MalfunctionSep 25, 2026Leak/Splash; Product Quality Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50903520 ↗
Other BD Switzerland Sàrl products
- 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
- 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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