Alaris 8110 (UDI 10885403424267)Recalls & reported problems

Summary

The FDA's MAUDE database contains 15,547 adverse event reports that list this exact device (DI 10885403424267), received between Aug 10, 2018 and Aug 26, 2026 — classified as 2 deaths, 28 injuries, 15,517 malfunctions.

The most frequently reported specific device problem is “Crack” (6,458 reports).

2 FDA recall records name this device's identifier, 2 still open.

7 other recalls cover devices cleared under the same FDA submission (K023264); they may or may not involve this specific model.

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 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 · 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 · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 15,547 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 26, 2026Break; Corroded; Deformation Due to Compressive Stress; Calibration Problem

  It was reported that the device had fails calibration for barrel size. There was no patient involvement.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50452712 ↗
• MalfunctionAug 18, 2026Deformation Due to Compressive Stress; Calibration Problem

  It was reported that the device had damaged plunger. There was no patient involvement.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50298022 ↗
• MalfunctionAug 18, 2026Break; Contamination; Deformation Due to Compressive Stress; Calibration Problem; Naturally Worn

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50295958 ↗
• MalfunctionJul 29, 2026Contamination; Failure to Read Input Signal; Inaccurate Delivery; Deformation Due to Compressive Stress; Device Sensing Problem; Naturally Worn

  It was reported that the device had plunger replacement. There was no patient involvement.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50070586 ↗
• MalfunctionJul 29, 2026Break; Inaccurate Delivery; Deformation Due to Compressive Stress

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50066392 ↗
• MalfunctionJul 16, 2026Break; Contamination

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25834699 ↗
• MalfunctionJul 16, 2026Corroded

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25834697 ↗
• MalfunctionJul 14, 2026Contamination

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25811064 ↗
• MalfunctionJul 13, 2026Break; Deformation Due to Compressive Stress; Naturally Worn

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25792039 ↗
• MalfunctionJul 1, 2026Device Alarm System; Failure to Read Input Signal

  IT WAS REPORTED THAT THE DEVICE DISPLAYED CHANNEL ERROR 357.6020. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25676623 ↗
• MalfunctionMay 5, 2026Break; Deformation Due to Compressive Stress; Naturally Worn

  IT WAS REPORTED THAT THE DEVICE HAD DAMAGED SYRINGE PLUNGER. NEEDS PLUNGER REPLACEMENT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25080548 ↗
• MalfunctionMay 5, 2026Device Alarm System; Break; Contamination; Corroded

  IT WAS REPORTED THAT THE DEVICE HAD ERROR ALARM CODE 352.6700. NEEDS LOGIC BOARD. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25078692 ↗
• MalfunctionMay 5, 2026Contamination; Calibration Problem

  IT WAS REPORTED THAT THE DEVICE HAD FAILED PLUNGER FORCE CALIBRATION. NEEDS PLUNGER REPLACEMENT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25078055 ↗
• MalfunctionApr 20, 2026Break

  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 24923583 ↗
• MalfunctionApr 2, 2026Break; Contamination; Deformation Due to Compressive Stress; Calibration Problem; Naturally Worn

  IT WAS REPORTED THAT THE DEVICE HAD DRIVE ARM SLIPS DURING FORCE ACCURACY. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24765020 ↗
• MalfunctionMar 31, 2026Break; Contamination; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT THE DEVICE HAD ERROR MESSAGE: 354.6770>>. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24740782 ↗
• MalfunctionMar 30, 2026Break; Deformation Due to Compressive Stress; Naturally Worn

  IT WAS REPORTED THAT THE DEVICE HAD BROKEN WIPER ASSEMBLY. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24712282 ↗
• MalfunctionMar 30, 2026Break; Naturally Worn

  IT WAS REPORTED THAT THE DEVICE HAD KEYPAD DAMAGE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24711309 ↗
• MalfunctionMar 25, 2026Break; Circuit Failure; Corroded; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT THE DEVICE HAD ERROR CODE 358.2000. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24685701 ↗
• MalfunctionMar 23, 2026Deformation Due to Compressive Stress; Naturally Worn

  IT WAS REPORTED THAT THE DEVICE HAD KEYPAD DAMAGE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24661092 ↗
• MalfunctionMar 23, 2026Break; Corroded; Deformation Due to Compressive Stress; Naturally Worn

  IT WAS REPORTED THAT THE DEVICE HAD ERROR MESSAGE 358.2000. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24661070 ↗
• MalfunctionMar 23, 2026Break; Contamination

  IT WAS REPORTED THAT THE DEVICE HAD ERROR MESSAGE: 357.6020. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24660863 ↗
• MalfunctionMar 23, 2026Break

  IT WAS REPORTED THAT THE DEVICE HAD ERROR MESSAGE: 354.6770. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24660768 ↗
• MalfunctionMar 18, 2026Break; Contamination

  IT WAS REPORTED THAT THE DEVICE HAD CHANNEL ERROR 352.6700. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24624632 ↗
• MalfunctionMar 17, 2026Output Problem

  IT WAS REPORTED THAT THE DEVICE HAD NEEDS PLUNGER REPLACEMENT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24615612 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K023264. One submission often covers many models, so check the product and lot details in each record.

• Z-1645-2026 · Feb 11, 2026 · Open, Classified
  BD Alaris" System with Guardrails" Suite MX with Point of Care Unit
• Z-0322-2018 · Nov 17, 2017 · Terminated
  Alaris Syringe Pump, Model 8110. The firm name on the label is CareFusion. The Alaris Syringe Pump module and Alaris PCA module are infusion pump modules for the Alaris System. T
• Z-2879-2016 · Aug 8, 2016 · Terminated
  Alaris Syringe Module Model 8110 with software version 9.15 The Alaris Syringe Pump module is part of the Alaris System. The syringe pump delivers fluids in a manner similar to cu
• Z-2362-2015 · Jul 21, 2015 · Terminated
  Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Pa
• Z-1794-2009 · Jun 12, 2009 · Terminated
  Alaris System Inter-Unit Interface (IUI) Connectors. The Modules include the following: Alaris PC Unit, Model Numbers 8000 and 8015; Alaris Pump Module, Model 8100; Alaris Patien
• Z-1711-2008 · Mar 5, 2008 · Terminated
  Grey Inter-Unit Interface Connectors ("IUI") on the following Alaris System modules built on or before March 26, 2004: (1) Alaris PC point-of-care unit ("PC Unit") (Model 8000)* (
• Z-1712-2008 · Mar 5, 2008 · Terminated
  U9 Socket Integrated Circuit ("U9 IC") on the display board of the following Alaris System modules built on or before October 4, 2005: (1) Alaris Syringe module (Model 8110) (a.k.a