BD Alaris Syringe Module, Model 8110Recalls & reported problems across all models

We found 2 models of BD Alaris Syringe Module, Model 8110 by Carefusion 303, Inc. in the FDA's device registry (GUDID). Together they are named in 3,183 adverse event reports in the FDA's MAUDE database, received between Oct 19, 2023 and Sep 30, 2026 — classified as 2 injuries, 3,178 malfunctions.

The most frequently reported specific device problem is “Break” (1,128 reports).

2 FDA recall records name at least one of these models by its device 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. 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

BD Alaris Syringe Module, Model 8110 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.

1. 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 · names 2 of these models · Recall details · FDA record ↗

2. 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 · names 2 of these models · Recall details · FDA record ↗

Most reported BD Alaris Syringe Module, Model 8110 problems

BD Alaris Syringe Module, Model 8110 models

2 models, most reported first. Each model has its own page with its reports, recalls and device details.

• BD® Alaris™ Syringe Module, Model 8110

  Pump, infusion
  2 recalls3,182 reports
• BD Alaris™ Syringe Module, Model 8110

  Pump, infusion
  2 recalls1 report

Recent BD Alaris Syringe Module, Model 8110 adverse event reports

The 15 most recent reports across all models, 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 ↗

Other Carefusion 303, Inc. products

• BD Alaris Infusion System29 models · 1,242,913 reports · 16 recalls
• Alaris25 models · 1,236,345 reports · 16 recalls
• BD Pyxis26 models · 81,193 reports · 66 recalls
• Pyxis5 models · 7,862 reports · 16 recalls
• BD Alaris PCU Model 80153 models · 4,071 reports · 2 recalls
• BD Alaris PCU Module, Model 80152 models · 3,078 reports · 3 recalls
• Alaris PCA Module, Model 81202 models · 918 reports · 2 recalls
• BD Alaris ETCO2 Module, Model 83002 models · 956 reports