Alaris 8110 (UDI 10885403811012)Recalls & reported problems
Carefusion 303, Inc. · Alaris Syringe Module · Class 2
2 open recalls name this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This Alaris 8110 syringe pump module has 21,938 adverse event reports in the FDA database, including 4 deaths and 45 injuries. Reports often describe parts that break, crack, or do not line up, and many state no patient was involved. There are 2 open recalls: one about a connector that may bend and delay the start of infusion, and one about syringe labeling listing syringes not validated for use. Reports in the last 12 months (270) are fewer than in the 12 months before (503).
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
- 21,956
- Deaths reported
- 4
- Injuries reported
- 45
- Recalls naming it
- 2
Summary
The FDA's MAUDE database contains 21,956 adverse event reports that list this exact device (DI 10885403811012), received between Oct 23, 2017 and Sep 28, 2026 — classified as 4 deaths, 45 injuries, 21,907 malfunctions.
The most frequently reported specific device problem is “Failure to Align” (6,772 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.
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 · 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 · FDA record ↗
Most reported problems
Device problems
- Failure to Align6,772
- Break5,582
- Crack4,592
- Corroded3,732
- Contamination2,463
- Deformation Due to Compressive Stress2,427
- Naturally Worn1,563
- No Apparent Adverse Event1,364
Patient problems
- No Clinical Signs, Symptoms or Conditions19,555
- No Patient Involvement2,136
- No Known Impact Or Consequence To Patient97
- Insufficient Information94
- No Consequences Or Impact To Patient89
- No Information44
- Low Blood Pressure/ Hypotension9
- Foreign Body In Patient6
Recent adverse event reports
The 25 most recent of 21,956 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 28, 2026Break
It was reported that the following issue was observed on the device: "NOT WORKING." Reported Problem Cause Description: "None Provided." Hence, the work Performed in the device includes: "NEED TO REPLACE DRIVE HOUSING ASSY." There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50910915 ↗MalfunctionSep 25, 2026Circuit Failure
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50902833 ↗MalfunctionSep 25, 2026Physical Resistance/Sticking
It was reported that a failure was observed during a planned preventative maintenance, recall remediation, or repair order service event. "[Repair Multi-Device]"; "[CM-Repair Multi-Device]". There was no reported patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50893723 ↗MalfunctionSep 23, 2026Calibration Problem
It was reported that a failure was observed during a planned preventative maintenance, recall remediation, or repair order service event. "[Depot Repair]";"[The plunger is tight.]". There was no reported patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50870526 ↗MalfunctionSep 22, 2026Device Alarm System
It was reported that a failure was observed during a planned preventative maintenance, recall remediation, or repair order service event. "[Depot Repair]";"[Error 352.6640 continuously occurs]". There was no reported patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50852240 ↗MalfunctionSep 18, 2026Break
It was reported that the following issue was observed on the device: CALIBRATION FAILED DURING PPM. Reported Problem Cause Description: FAULTY DRIVE HOUSING ASSY. Hence, the work Performed in the device includes: REPLACED DRIVE HOUSING ASSY. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50817576 ↗MalfunctionSep 18, 2026Break
It was reported that the following issue was observed on the device: CALIBRATION FAILED DURING PPM. Reported Problem Cause Description: FAULTY DRIVE HOUSING ASSY. Hence, the work Performed in the device includes: REPLACED DRIVE HOUSING ASSY. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50816818 ↗MalfunctionSep 17, 2026Device Alarm System
It was reported that a failure was observed during a planned preventative maintenance, recall remediation, or repair order service event. "[Repair Multi-Device]";"[Alaris system repairs with a combination of faults.]". There was no reported patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50800954 ↗MalfunctionSep 17, 2026Break
It was reported that the following issue was observed on the device: CALIBRATION FAILED DURING PPM. Reported Problem Cause Description: FAULTY DRIVE HOUSING ASSY. Hence, the work Performed in the device includes: REPLACED DRIVE HOUSING ASSY. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50797960 ↗MalfunctionSep 16, 2026Calibration Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50788798 ↗MalfunctionSep 16, 2026Break
It was reported that the following issue was observed on the device: "NOT WORKING." Reported Problem Cause Description: "HARDWARE FAILURE." Hence, the work Performed in the device includes: "REPLACED KIT DRIVE HOUSING ASSEMBLY. PERFORMED CALIBRATION AND PPM." There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50785173 ↗MalfunctionSep 15, 2026Calibration Problem
It was reported that a failure was observed during a planned preventative maintenance, recall remediation, or repair order service event. "[Depot Repair]";"[Failed force calibration]". There was no reported patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50769766 ↗MalfunctionSep 14, 2026Break
It was reported that the following issue was observed on the device: "BROKEN." Reported Problem Cause Description: "UNIT CHECKED AND FOUND WEAR AND TEAR - FRONT CASE, REAR CASE, MYLAR GASKET, HOLDER TOP DICS, RIGHT IUI BROKEN. REPLACED FRONT CASE, REAR CASE, MYLAR GASKET, HOLDER TOP DICS, RIGHT IUI. & CALIBRATED." Hence, the work Performed in the device includes: "UNIT CHECKED AND FOUND WEAR AND TEAR-FRONT CASE, REAR CASE, MYLAR GASKET, HOLDER TOP DICS, RIGHT IUI BROKEN. NEED TO REPLACE - (FRONT CASE - (b)(4) , QTY - (b)(4) , (REAR CASE - (b)(4) , QTY - (b)(4) (MYLAR GASKET - (b)(4), QTY - (b)(4) , (HOLDER TOP DICS - (b)(4) , QTY - (b)(4) ( RIGHT IUI - (b)(4) ,QTY - (b)(4)." There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50749280 ↗MalfunctionSep 11, 2026Device Alarm System
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50729388 ↗MalfunctionSep 10, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50714893 ↗MalfunctionSep 10, 2026Physical Resistance/Sticking
It was reported that a failure was observed during a planned preventative maintenance, recall remediation, or repair order service event. "[Field Service]";"[Failed preventative maintenance due to a cracked rear case and a jammed and binding module latch.No patient involvement - observed during routine preventative maintenance.]". There was no reported patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50712433 ↗MalfunctionSep 10, 2026Device Alarm System
It was reported that the following issue was observed on the device: "CHANNEL ERROR". Reported Problem Cause Description: "FAULTY PRESSURE SENSOR BOARD." Hence, the work Performed in the device includes: "UNIT CHECKED & FOUND ERROR CODE 354.6690. REPLACED PRESSURE SENSOR BOARD. UNIT CHECKED & NOW WORKING OK." There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50706642 ↗MalfunctionSep 9, 2026Break
It was reported that the following issue was observed on the device: "BROKEN." Reported Problem Cause Description: None provided." Hence, the work Performed in the device includes: "UNIT CHECKED AND FOUND WEAR AND TEAR - FRONT CASE, REAR CASE, INTERNAL FRAME BROKEN. NEED TO BE REPLACED ( (b)(4) - FRONT CASE , (b)(4) - REAR CASE , (b)(4) INTERNAL FRAME)." There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50688852 ↗MalfunctionSep 9, 2026Electrical /Electronic Property Problem
It was reported that a failure was observed during a planned preventative maintenance, recall remediation, or repair order service event. "[Depot Repair]";"[Failed the keypad test]". There was no reported patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50686094 ↗MalfunctionSep 4, 2026Calibration Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50610699 ↗MalfunctionSep 4, 2026Device Alarm System; Corroded
It was reported that a failure was observed during a planned preventative maintenance, recall remediation, or repair order service event. "[Depot Repair]";"[Plunger is hard to move and rusting inside the barrel clamp.]". There was no reported patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50603761 ↗MalfunctionAug 31, 2026Device Alarm System
It was reported that the device had error code 351.6660. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50518161 ↗MalfunctionAug 28, 2026Device Alarm System
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50490771 ↗MalfunctionAug 27, 2026Failure to Align
It was reported that a failure was observed during a planned preventative maintenance, recall remediation, or repair order service event. "[Depot Repair]"; "[repair only]". There was no reported patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50469753 ↗MalfunctionAug 25, 2026Device Alarm System
It was reported that a failure was observed during a planned preventative maintenance, recall remediation, or repair order service event. "[Depot Repair]";"[BD 8110 syringe pump with serial number (b)(6) which do not display channel ID on the left hand side IUI connector(even new IUI connector install). However, channel ID display on the right hand side IUI connector.]". There was no reported patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50427803 ↗
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, ClassifiedBD Alaris" System with Guardrails" Suite MX with Point of Care Unit
- Z-0322-2018 · Nov 17, 2017 · TerminatedAlaris 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 · TerminatedAlaris 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 · TerminatedAlaris 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 · TerminatedAlaris 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-1712-2008 · Mar 5, 2008 · TerminatedU9 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
- Z-1711-2008 · Mar 5, 2008 · TerminatedGrey 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)* (
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 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
- CADD 21-6400-51Icu Medical, Inc. · Pump, infusion7 deaths7,543 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.