Alaris 8015 (UDI 10885403801518)Recalls & reported problems

Summary

The FDA's MAUDE database contains 148,093 adverse event reports that list this exact device (DI 10885403801518), received between Oct 23, 2017 and Sep 30, 2026 — classified as 45 deaths, 233 injuries, 147,815 malfunctions.

The most frequently reported specific device problem is “Corroded” (44,540 reports).

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

25 other recalls cover devices cleared under the same FDA submission (K051641); 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-3138-2024 · 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-0186-2024 · Root cause: Under Investigation by firm · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 148,093 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Premature Discharge of Battery

  It was reported that a failure was observed during a planned preventive maintenance or recall remediation service event. There was no reported patient involvement.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50942095 ↗
• MalfunctionSep 29, 2026Break; Contamination; Corroded

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50931434 ↗
• MalfunctionSep 24, 2026Electrical /Electronic Property Problem

  It was reported that the following issue was observed on the device: "DEFECTIVE PCU KEYPAD ASSEMBLY." Reported Problem Cause Description: "HARDWARE FAILURE." Hence, the work Performed in the device includes: "Found defective PCU keypad assembly and replaced it." There was no patient involvement.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50882638 ↗
• MalfunctionSep 24, 2026Communication or Transmission Problem

  It was reported that a failure was observed during a planned preventative maintenance, recall remediation, or repair order service event. "[Field Service]";"[Channel error]". There was no reported patient involvement.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50880026 ↗
• MalfunctionSep 21, 2026Communication or Transmission Problem

  It was reported that a failure was observed during a planned preventative maintenance, recall remediation, or repair order service event. "[Field Service]";"[Channel error]". There was no reported patient involvement.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50837130 ↗
• MalfunctionSep 18, 2026Corroded

  It was reported that a failure was observed during a planned preventative maintenance, recall remediation, or repair order service event. "[Depot Repair]";"[service required]". There was no reported patient involvement.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50817577 ↗
• MalfunctionSep 18, 2026Corroded

  It was reported that the device may have been affected by water ingress, as the sprinkler system was activated during a fire incident at the hospital, also potential smoke damage. There was patient involvement, but no harm.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50814858 ↗
• MalfunctionSep 18, 2026Corroded

  It was reported that the device may have been affected by water ingress, as the sprinkler system was activated during a fire incident at the hospital, also potential smoke damage. There was patient involvement, but no harm.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50813675 ↗
• MalfunctionSep 18, 2026Corroded

  It was reported that the device may have been affected by water ingress, as the sprinkler system was activated during a fire incident at the hospital, also potential smoke damage. There was patient involvement, but no harm.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50813674 ↗
• MalfunctionSep 18, 2026Corroded

  It was reported that the device may have been affected by water ingress, as the sprinkler system was activated during a fire incident at the hospital, also potential smoke damage. There was patient involvement, but no harm.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50813664 ↗
• MalfunctionSep 18, 2026Corroded

  It was reported that the device may have been affected by water ingress, as the sprinkler system was activated during a fire incident at the hospital, also potential smoke damage. There was patient involvement, but no harm.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50813663 ↗
• MalfunctionSep 17, 2026Premature Discharge of Battery

  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 50800951 ↗
• MalfunctionSep 17, 2026Device Alarm System

  It was reported that the following issue was observed on the device: "SYSTEM ERROR." Reported Problem Cause Description: "None Provided." Hence, the work Performed in the device includes: "NEED TO REPLACE LOGIC BOARD." There was no patient involvement.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50797780 ↗
• MalfunctionSep 14, 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]";"[Error code, logic board fault.]". There was no reported patient involvement.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50752253 ↗
• MalfunctionSep 11, 2026Break

  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 50726396 ↗
• MalfunctionSep 9, 2026Display or Visual Feedback Problem

  It was reported that a failure was observed during a planned preventative maintenance, recall remediation, or repair order service event. "[Depot Repair]";"[Screen flickering]". There was no reported patient involvement.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50690906 ↗
• MalfunctionSep 9, 2026Use of Device Problem

  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 50688842 ↗
• MalfunctionSep 9, 2026Corroded

  It was reported that a failure was observed during a planned preventive maintenance or recall remediation service event. There was no reported patient involvement.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50686910 ↗
• MalfunctionSep 8, 2026Circuit Failure

  It was reported that a failure was observed during a planned preventative maintenance, recall remediation, or repair order service event. "[Depot Repair]"; "[a controller unit SN: (b)(6) with a defective PSU]". There was no reported patient involvement.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50667774 ↗
• MalfunctionSep 8, 2026Contamination

  It was reported that a failure was observed during a planned preventative maintenance, recall remediation, or repair order service event. "[Field Service]";"[Equipment fault: Network Comm Error (600.6875)]". There was no reported patient involvement.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50664019 ↗
• MalfunctionSep 3, 2026Device Alarm System; Corroded

  It was reported that a failure was observed during a planned preventative maintenance, recall remediation, or repair order service event. "["[Service Type]"]"; "[faulty 8015 SN (b)(6) gives error 800.8000]". There was no reported patient involvement.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50589647 ↗
• MalfunctionSep 3, 2026Battery Problem

  It was reported that a failure was observed during a planned preventative maintenance, recall remediation, or repair order service event. "[Depot Repair]";"[Fault: battery failure]". There was no reported patient involvement.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50589630 ↗
• MalfunctionSep 2, 2026Corroded

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50569749 ↗
• MalfunctionSep 2, 2026Contamination

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50562018 ↗
• MalfunctionSep 1, 2026Battery Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50539173 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K051641. 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-0184-2024 · Sep 15, 2023 · Open, Classified
  BD Alaris PCU REF 8015
• Z-0185-2024 · Sep 15, 2023 · Open, Classified
  BD Alaris Syringe Module, REF 8110
• Z-1360-2020 · Feb 4, 2020 · Open, Classified
  CareFusion Alaris Pump Module, Model 8100
• Z-1362-2020 · Feb 4, 2020 · Open, Classified
  CareFusion Alaris PCA Module, Model 8120
• Z-1361-2020 · Feb 4, 2020 · Open, Classified
  CareFusion Alaris Syringe Module, Model 8110
• Z-2671-2017 · Jun 12, 2017 · Terminated
  Alaris PC Unit, Model 8015
• Z-1520-2017 · Nov 1, 2016 · Terminated
  Alaris System PC unit, model no. 8000 and 8015. The central programming, monitoring and power supply component for the Alaris infusion pump System.
• Z-2064-2016 · May 12, 2016 · Terminated
  Alaris System PC Unit Model 8015 with software versions 9.17 and 9.19; Central programming, monitoring and power supply component for the Alaris System.
• Z-1606-2016 · Mar 24, 2016 · Terminated
  Alaris PC unit, Model 8015 The Alaris PC unit is the central programming, monitoring and power supply component for the Alaris System.
• Z-1239-2016 · Feb 12, 2016 · Terminated
  Alaris PC Unit, Infusion Pump Model 8000, Part No. TC10005092
• Z-1811-2015 · May 13, 2015 · Terminated
  Alaris PC unit model 8015, Infusion pump. software version 9.17 Product Usage: The Alaris PC unit is the central programming, monitoring and power supply component for the Alaris
• Z-1311-2015 · Mar 12, 2015 · Terminated
  Alaris PC units, Model No. 8015. Infusion pump.
• Z-0534-2014 · Dec 5, 2013 · Terminated
  Alaris PC unit model 8000 and 8015 with Alaris PCA module model 8120 and Auto ID barcode scanner model 8600. Product Usage: The Alaris PC unit is the central programming, monitor
• Z-1835-2013 · Jun 17, 2013 · Terminated
  Alaris PC unit, model 8015, with version 9.12-Keyboard Processor and logic board assembly part number TC10006584. The Alaris PC Unit is the main user interface unit and power supp

…and 10 more.