Alaris 8110 (UDI 10885403811036)Recalls & reported problems
Carefusion 303, Inc. · Alaris Syringe Module · Class 2
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This Alaris 8110 syringe module is a pump module that delivers medication from a syringe. Its 741 reports mostly describe malfunctions, including broken or cracked parts, software freezing or failing to start, and corroded or worn components. The reports include no deaths and 6 injuries. One recall, open since August 2024, concerns a bent connector that could delay the start of infusion or monitoring.
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
- 748
- Deaths reported
- 0
- Injuries reported
- 6
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 748 adverse event reports that list this exact device (DI 10885403811036), received between Apr 13, 2020 and Sep 22, 2026 — classified as 6 injuries, 742 malfunctions.
The most frequently reported specific device problem is “Break” (230 reports).
1 FDA recall record name this device's identifier, 1 still open.
5 other recalls cover devices cleared under the same FDA submission (K072105); 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 ↗
Most reported problems
Device problems
- Break230
- Application Program Freezes or Fails to Launch169
- Deformation Due to Compressive Stress113
- Corroded104
- Crack93
- Naturally Worn80
- Physical Resistance/Sticking64
- Device Alarm System55
Patient problems
- No Clinical Signs, Symptoms or Conditions706
- No Patient Involvement30
- Insufficient Information8
- No Consequences Or Impact To Patient7
- Extravasation1
- Hypoglycemia1
- Infiltration into Tissue1
- No Information1
Recent adverse event reports
The 25 most recent of 748 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 22, 2026Corroded
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50853266 ↗MalfunctionSep 16, 2026Device Alarm System
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50785705 ↗MalfunctionSep 15, 2026Calibration Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50768188 ↗MalfunctionSep 13, 2026Break; Corroded; Physical Resistance/Sticking
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50747821 ↗MalfunctionSep 9, 2026Break; Corroded; Component Misassembled
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50683620 ↗MalfunctionSep 3, 2026Break; Corroded; Physical Resistance/Sticking
It was reported that a failure was observed during a planned preventative maintenance, recall remediation, or repair order service event. "[Depot Repair]"; "[Failed calibration]". There was no reported patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50579670 ↗MalfunctionAug 26, 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]";"[8110 sn: (b)(6) gives error 351.6740.0]". There was no reported patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50456655 ↗MalfunctionJul 31, 2026Naturally Worn
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50098290 ↗MalfunctionJul 27, 2026Break; Crack
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50034013 ↗MalfunctionJul 27, 2026Break; Crack; Electrical /Electronic Property Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50033491 ↗MalfunctionJul 27, 2026Break; Crack
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50033490 ↗MalfunctionJul 1, 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 syringe calibration]". There was no reported patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25676630 ↗MalfunctionJun 5, 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; RELEASE LATCH ERROR - KEEPS STICKING AND JAMMING. THERE WAS NO REPORTED PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25413719 ↗MalfunctionJun 5, 2026Device Alarm System; Circuit Failure; Component Misassembled
It was reported that a failure was observed during a planned preventative maintenance, recall remediation, or repair order service event. "[Depot Repair]";"[Error message ¿channel error¿ and unable to be used afterwards.]". There was no reported patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25407209 ↗MalfunctionMay 14, 2026Device Alarm System
IT WAS REPORTED THAT THE CUSTOMER IS ENCOUNTERING AND INCREASED NUMBER CHANNEL ERRORS WHEN CONNECTING THE DEVICE TO THE PCU. COMMON ERROR CODES SEEN ARE 211.2 AND 221.201. CUSTOMER HAS CONDUCTED PRELIMINARY TESTING AND STATES THAT AFTER FLASHING THE PUMP, THE DEVICE WILL OPERATE NORMALLY FOR A FEW MINUTES, AFTER WHICH THE SAME CHANNEL ERROR WILL REAPPEAR. THE CUSTOMER HAS REPLACED THE LOGIC BOARD IN MANY OF THE DEVICES. FOLLOWING LOGIC BOARD REPLACEMENT, THE DEVICE WILL OPERATE AS NORMAL, WITHOUT CHANNEL ERRORS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25172964 ↗MalfunctionMay 14, 2026Device Alarm System
IT WAS REPORTED THAT THE CUSTOMER IS ENCOUNTERING AND INCREASED NUMBER CHANNEL ERRORS WHEN CONNECTING THE DEVICE TO THE PCU. COMMON ERROR CODES SEEN ARE 211.2 AND 221.201. CUSTOMER HAS CONDUCTED PRELIMINARY TESTING AND STATES THAT AFTER FLASHING THE PUMP, THE DEVICE WILL OPERATE NORMALLY FOR A FEW MINUTES, AFTER WHICH THE SAME CHANNEL ERROR WILL REAPPEAR. THE CUSTOMER HAS REPLACED THE LOGIC BOARD IN MANY OF THE DEVICES. FOLLOWING LOGIC BOARD REPLACEMENT, THE DEVICE WILL OPERATE AS NORMAL, WITHOUT CHANNEL ERRORS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25170030 ↗MalfunctionMay 14, 2026Device Alarm System
IT WAS REPORTED THAT THE CUSTOMER IS ENCOUNTERING AND INCREASED NUMBER CHANNEL ERRORS WHEN CONNECTING THE DEVICE TO THE PCU. COMMON ERROR CODES SEEN ARE 211.2 AND 221.201. CUSTOMER HAS CONDUCTED PRELIMINARY TESTING AND STATES THAT AFTER FLASHING THE PUMP, THE DEVICE WILL OPERATE NORMALLY FOR A FEW MINUTES, AFTER WHICH THE SAME CHANNEL ERROR WILL REAPPEAR. THE CUSTOMER HAS REPLACED THE LOGIC BOARD IN MANY OF THE DEVICES. FOLLOWING LOGIC BOARD REPLACEMENT, THE DEVICE WILL OPERATE AS NORMAL, WITHOUT CHANNEL ERRORS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25168583 ↗MalfunctionMay 14, 2026Device Alarm System
IT WAS REPORTED THAT THE CUSTOMER IS ENCOUNTERING AND INCREASED NUMBER CHANNEL ERRORS WHEN CONNECTING THE DEVICE TO THE PCU. COMMON ERROR CODES SEEN ARE 211.2 AND 221.201. CUSTOMER HAS CONDUCTED PRELIMINARY TESTING AND STATES THAT AFTER FLASHING THE PUMP, THE DEVICE WILL OPERATE NORMALLY FOR A FEW MINUTES, AFTER WHICH THE SAME CHANNEL ERROR WILL REAPPEAR. THE CUSTOMER HAS REPLACED THE LOGIC BOARD IN MANY OF THE DEVICES. FOLLOWING LOGIC BOARD REPLACEMENT, THE DEVICE WILL OPERATE AS NORMAL, WITHOUT CHANNEL ERRORS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25168472 ↗MalfunctionMay 14, 2026Device Alarm System
IT WAS REPORTED THAT THE CUSTOMER IS ENCOUNTERING AND INCREASED NUMBER CHANNEL ERRORS WHEN CONNECTING THE DEVICE TO THE PCU. COMMON ERROR CODES SEEN ARE 211.2 AND 221.201. CUSTOMER HAS CONDUCTED PRELIMINARY TESTING AND STATES THAT AFTER FLASHING THE PUMP, THE DEVICE WILL OPERATE NORMALLY FOR A FEW MINUTES, AFTER WHICH THE SAME CHANNEL ERROR WILL REAPPEAR. THE CUSTOMER HAS REPLACED THE LOGIC BOARD IN MANY OF THE DEVICES. FOLLOWING LOGIC BOARD REPLACEMENT, THE DEVICE WILL OPERATE AS NORMAL, WITHOUT CHANNEL ERRORS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25168155 ↗MalfunctionMay 14, 2026Device Alarm System
IT WAS REPORTED THAT THE CUSTOMER IS ENCOUNTERING AND INCREASED NUMBER CHANNEL ERRORS WHEN CONNECTING THE DEVICE TO THE PCU. COMMON ERROR CODES SEEN ARE 211.2 AND 221.201. CUSTOMER HAS CONDUCTED PRELIMINARY TESTING AND STATES THAT AFTER FLASHING THE PUMP, THE DEVICE WILL OPERATE NORMALLY FOR A FEW MINUTES, AFTER WHICH THE SAME CHANNEL ERROR WILL REAPPEAR. THE CUSTOMER HAS REPLACED THE LOGIC BOARD IN MANY OF THE DEVICES. FOLLOWING LOGIC BOARD REPLACEMENT, THE DEVICE WILL OPERATE AS NORMAL, WITHOUT CHANNEL ERRORS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25168150 ↗MalfunctionMay 14, 2026Device Alarm System
IT WAS REPORTED THAT THE CUSTOMER IS ENCOUNTERING AND INCREASED NUMBER CHANNEL ERRORS WHEN CONNECTING THE DEVICE TO THE PCU. COMMON ERROR CODES SEEN ARE 211.2 AND 221.201. CUSTOMER HAS CONDUCTED PRELIMINARY TESTING AND STATES THAT AFTER FLASHING THE PUMP, THE DEVICE WILL OPERATE NORMALLY FOR A FEW MINUTES, AFTER WHICH THE SAME CHANNEL ERROR WILL REAPPEAR. THE CUSTOMER HAS REPLACED THE LOGIC BOARD IN MANY OF THE DEVICES. FOLLOWING LOGIC BOARD REPLACEMENT, THE DEVICE WILL OPERATE AS NORMAL, WITHOUT CHANNEL ERRORS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25168084 ↗MalfunctionMay 14, 2026Device Alarm System
IT WAS REPORTED THAT THE CUSTOMER IS ENCOUNTERING AND INCREASED NUMBER CHANNEL ERRORS WHEN CONNECTING THE DEVICE TO THE PCU. COMMON ERROR CODES SEEN ARE 211.2 AND 221.201. CUSTOMER HAS CONDUCTED PRELIMINARY TESTING AND STATES THAT AFTER FLASHING THE PUMP, THE DEVICE WILL OPERATE NORMALLY FOR A FEW MINUTES, AFTER WHICH THE SAME CHANNEL ERROR WILL REAPPEAR. THE CUSTOMER HAS REPLACED THE LOGIC BOARD IN MANY OF THE DEVICES. FOLLOWING LOGIC BOARD REPLACEMENT, THE DEVICE WILL OPERATE AS NORMAL, WITHOUT CHANNEL ERRORS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25168065 ↗MalfunctionMay 14, 2026Device Alarm System
IT WAS REPORTED THAT THE CUSTOMER IS ENCOUNTERING AND INCREASED NUMBER CHANNEL ERRORS WHEN CONNECTING THE DEVICE TO THE PCU. COMMON ERROR CODES SEEN ARE 211.2 AND 221.201. CUSTOMER HAS CONDUCTED PRELIMINARY TESTING AND STATES THAT AFTER FLASHING THE PUMP, THE DEVICE WILL OPERATE NORMALLY FOR A FEW MINUTES, AFTER WHICH THE SAME CHANNEL ERROR WILL REAPPEAR. THE CUSTOMER HAS REPLACED THE LOGIC BOARD IN MANY OF THE DEVICES. FOLLOWING LOGIC BOARD REPLACEMENT, THE DEVICE WILL OPERATE AS NORMAL, WITHOUT CHANNEL ERRORS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25168055 ↗MalfunctionMay 13, 2026Device Alarm System
IT WAS REPORTED THAT THE CUSTOMER IS ENCOUNTERING AND INCREASED NUMBER CHANNEL ERRORS WHEN CONNECTING THE DEVICE TO THE PCU. COMMON ERROR CODES SEEN ARE 211.2 AND 221.201. CUSTOMER HAS CONDUCTED PRELIMINARY TESTING AND STATES THAT AFTER FLASHING THE PUMP, THE DEVICE WILL OPERATE NORMALLY FOR A FEW MINUTES, AFTER WHICH THE SAME CHANNEL ERROR WILL REAPPEAR. THE CUSTOMER HAS REPLACED THE LOGIC BOARD IN MANY OF THE DEVICES. FOLLOWING LOGIC BOARD REPLACEMENT, THE DEVICE WILL OPERATE AS NORMAL, WITHOUT CHANNEL ERRORS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25160292 ↗MalfunctionMay 13, 2026Device Alarm System
IT WAS REPORTED THAT THE CUSTOMER IS ENCOUNTERING AND INCREASED NUMBER CHANNEL ERRORS WHEN CONNECTING THE DEVICE TO THE PCU. COMMON ERROR CODES SEEN ARE 211.2 AND 221.201. CUSTOMER HAS CONDUCTED PRELIMINARY TESTING AND STATES THAT AFTER FLASHING THE PUMP, THE DEVICE WILL OPERATE NORMALLY FOR A FEW MINUTES, AFTER WHICH THE SAME CHANNEL ERROR WILL REAPPEAR. THE CUSTOMER HAS REPLACED THE LOGIC BOARD IN MANY OF THE DEVICES. FOLLOWING LOGIC BOARD REPLACEMENT, THE DEVICE WILL OPERATE AS NORMAL, WITHOUT CHANNEL ERRORS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25160284 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K072105. 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-0184-2024 · Sep 15, 2023 · Open, ClassifiedBD Alaris PCU REF 8015
- Z-0186-2024 · Sep 15, 2023 · Open, ClassifiedAlaris PCA Module 8120
- Z-0185-2024 · Sep 15, 2023 · Open, ClassifiedBD Alaris Syringe Module, REF 8110
- Z-1192-2023 · Jan 24, 2023 · Open, ClassifiedAlaris PC Unit 8015 utilizing 802.11 b/g or 802.11 a/b/g wireless network cards, with IP addresses from x.x.x.224 to x.x.x.255
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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.