BD® Alaris™ Syringe Module, Model 8110Recalls & reported problems
Carefusion 303, Inc. · BD Alaris™ Syringe Module, Model 8110 v12.3.0 · Class 2
All models of BD Alaris Syringe Module, Model 8110 (2)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
2 open recalls name this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This BD Alaris syringe module is an infusion pump component. Its 2,980 adverse event reports often describe parts breaking or deforming, calibration problems and alarm faults. Many recent reports cite failed tests during service visits, with no patient involved. The reports include no deaths and 2 injuries. Two open recalls name this device, over a bent connector and over syringe compatibility labels. Reports rose to 1,600 over the last year, from 1,108 the year before.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 3,182
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 2
Summary
The FDA's MAUDE database contains 3,182 adverse event reports that list this exact device (DI 10885403516047), received between Nov 17, 2023 and Sep 30, 2026 — classified as 2 injuries, 3,177 malfunctions.
The most frequently reported specific device problem is “Break” (1,128 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Recalls naming this device
- Aug 15, 2024Open, Classified
Due to affected devices that may have bent female IUI connector and may not be operable and potentially cause delays in the start of the infusion or monitoring.
Z-3141-2024 · Root cause: Process control · Recall details · FDA record ↗
- Sep 15, 2023Open, Classified
Alaris PCA Module 8120, Patient Controlled Analgesia infusion pump: compatible syringes labeling contains syringes that have not been validated.
Z-0185-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Most reported problems
Device problems
- Break1,128
- Deformation Due to Compressive Stress812
- Calibration Problem548
- Device Alarm System459
- Naturally Worn351
- Device Sensing Problem247
- Contamination161
- Loose or Intermittent Connection99
Patient problems
- No Clinical Signs, Symptoms or Conditions3,153
- Insufficient Information27
- Low Blood Pressure/ Hypotension2
- Laceration(s)1
Recent adverse event reports
The 25 most recent of 3,182 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Deformation Due to Compressive Stress
It was reported that the device was missing a piece. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50945185 ↗MalfunctionSep 30, 2026Circuit Failure; Contamination
It was reported that the device had failed calibration test. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50945180 ↗MalfunctionSep 30, 2026Break; Physical Resistance/Sticking
It was reported that the device had knob has broken off. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50945177 ↗MalfunctionSep 30, 2026Break
It was reported that the device had plunger force accuracy failed. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50945154 ↗MalfunctionSep 30, 2026Break
It was reported that the device had failed preventive maintenance due to an issue with the plunger forced part. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50945149 ↗MalfunctionSep 30, 2026Calibration Problem
It was reported that the device had failed split nut closed test. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50945144 ↗MalfunctionSep 30, 2026Calibration Problem
It was reported that the device had failed preventive maintenance - force verification. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50945130 ↗MalfunctionSep 30, 2026Break
It was reported that the device syringe housing assembly moves up and down without twisting the knob. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50944201 ↗MalfunctionSep 30, 2026Device Alarm System
It was reported that the device had failed pm, pressure sensor error. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50944175 ↗MalfunctionSep 30, 2026Break; Contamination
It was reported that the device was missing a piece. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50941957 ↗MalfunctionSep 29, 2026Naturally Worn
It was reported that the device had device failed preventative maintenance check and calibration. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50933780 ↗MalfunctionSep 29, 2026Device Sensing Problem
It was reported that the device had barrel clamp broken. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50932724 ↗MalfunctionSep 29, 2026Deformation Due to Compressive Stress
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50932720 ↗MalfunctionSep 29, 2026Device Alarm System
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50932678 ↗MalfunctionSep 29, 2026Break; Deformation Due to Compressive Stress
It was reported that the device had failed PM, won't turn on. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50931589 ↗MalfunctionSep 29, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50931428 ↗MalfunctionSep 29, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50931426 ↗MalfunctionSep 29, 2026Calibration Problem
It was reported that the device had Failed plunger position and accuracy test. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50930744 ↗MalfunctionSep 29, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50930733 ↗MalfunctionSep 29, 2026Break
It was reported that the device had failed preventive maintenance and motor was not engaging. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50930732 ↗MalfunctionSep 29, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50930730 ↗MalfunctionSep 29, 2026Break
It was reported that the device had failed preventive maintenance and motor was not engaging. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50930729 ↗MalfunctionSep 29, 2026Break
It was reported that the device had failed preventive maintenance and motor was not engaging. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50930714 ↗MalfunctionSep 28, 2026Break; Contamination
It was reported that the device had error code 354.6770. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50914071 ↗MalfunctionSep 28, 2026Break; Contamination
It was reported that the device had Missing claws. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50914069 ↗
Other Pump, infusion devices
- Alaris 8100Carefusion 303, Inc. · Pump, infusion2 recalls2 deaths650,218 reports
- Alaris 8100Carefusion 303, Inc. · Pump, infusion4 recalls78 deaths344,514 reports
- Alaris 8015Carefusion 303, Inc. · Pump, infusion2 recalls45 deaths148,093 reports
- BD® Alaris™ Pump Module, Model 8100Carefusion 303, Inc. · Pump, infusion5 recalls30 deaths51,256 reports
- Alaris 8110Carefusion 303, Inc. · Pump, infusion2 recalls4 deaths21,956 reports
- Alaris 8110Carefusion 303, Inc. · Pump, infusion2 recalls2 deaths15,547 reports
- Alaris 8015Carefusion 303, Inc. · Pump, infusion3 recalls6 deaths13,022 reports
- CADD 21-6500-51Icu Medical, Inc. · Pump, infusion2 deaths8,231 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- 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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