Alaris 8015 (UDI 10885403801532)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4,302 adverse event reports that list this exact device (DI 10885403801532), received between Jul 29, 2020 and Sep 22, 2026 — classified as 3 injuries, 4,299 malfunctions.

The most frequently reported specific device problem is “Failure to Read Input Signal” (1,411 reports).

4 FDA recall records name this device's identifier, 4 still open.

2 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Recalls naming this device

1. Feb 11, 2026Open, Classified

   Due to product labeling not indicating which Transport Layer Security (TLS) version that must be enabled on hospital network to ensure secure Wi-Fi communication with Point-of-Care Units

   Z-1645-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

2. 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 · Recall details · FDA record ↗

3. 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 · Recall details · FDA record ↗

4. Jan 24, 2023Open, Classified

   Infusion pump PCs with specific software/network cards/IP addresses can have network/wireless connection failure. Could cause inability to receive new datasets and inability to transfer retrospective analytics data to connected systems. Users with interfaces to electronic medication record or admin discharge transfer, may be unable to receive/send data; infusions may need to be manually programmed

   Z-1192-2023 · Root cause: Software Design Change · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 4,302 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 22, 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. "[Field Service]"; "[Failed schedule PM due to Display Flickering]". There was no reported patient involvement.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50853516 ↗
• MalfunctionSep 22, 2026Break; Corroded; Display or Visual Feedback Problem

  It was reported that a failure was observed during a planned preventative maintenance, recall remediation, or repair order service event. "[Field Service]";"[Failed schedule PM due to Display Flickering, broken pole clamp and Female IUI connector]". There was no reported patient involvement.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50852241 ↗
• MalfunctionAug 28, 2026Display or Visual Feedback Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50495374 ↗
• MalfunctionAug 27, 2026Premature Discharge of Battery; Contamination; Corroded

  It was reported that the at 1730 on (b)(6) 2026 Propofol and Fentanyl were infusing when devices had alarmed channel error on all 3 channels simultaneously requiring all infusions to be transferred to new pumps. Infusions were quickly transferred to new modules. Patient appeared to remain comfortably sedated throughout transfer of sedation medications to new pump. There was patient involvement however no harm.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50472633 ↗
• MalfunctionAug 24, 2026Break

  It was reported that a failure was observed during a planned preventative maintenance, recall remediation, or repair order service event. "[Field Service]";"[Failed scheduled PM due to broken Female IUI connector Replaced IUI connector]". There was no reported patient involvement.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50412188 ↗
• MalfunctionAug 13, 2026Break; Display or Visual Feedback Problem

  It was reported that a failure was observed during a planned preventative maintenance, recall remediation, or repair order service event. Field Service ; Failed Scheduled PM due to faulty SIO board. Replaced SIO board. There was no reported patient involvement.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50232869 ↗
• MalfunctionAug 13, 2026Break; Display or Visual Feedback Problem

  It was reported that a failure was observed during a planned preventative maintenance, recall remediation, or repair order service event. "[Field Service]";"[Failed Scheduled PM due to faulty SIO board.Replaced SIO board]". There was no reported patient involvement.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50232576 ↗
• MalfunctionAug 13, 2026Break

  It was reported that a failure was observed during a planned preventative maintenance, recall remediation, or repair order service event. "[Field Service]"; "[Failed schedule PM inspection due to damaged pin on the left IUI. No patient involvement - Failure observed during routine preventative maintenance.]". There was no reported patient involvement.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50231700 ↗
• MalfunctionJul 31, 2026Physical Resistance/Sticking

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50098284 ↗
• MalfunctionJul 31, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50096960 ↗
• MalfunctionJul 31, 2026Display or Visual Feedback Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50096956 ↗
• MalfunctionJul 31, 2026Physical Resistance/Sticking

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50096952 ↗
• MalfunctionJul 17, 2026Display or Visual Feedback Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25853227 ↗
• MalfunctionJul 16, 2026Corroded

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25837681 ↗
• MalfunctionJul 3, 2026Output Problem

  IT WAS REPORTED THAT THE FOLLOWING ISSUE WAS OBSERVED ON THE DEVICE: "NOT WORKING." REPORTED PROBLEM CAUSE DESCRIPTION: "SIO BOARD ASSY." HENCE, THE WORK PERFORMED IN THE DEVICE INCLUDES: "CHECKED THE UNIT AND FOUND THAT, SIO BOARD ASSY WAS FAULTY. NEED TO REPLACE THE PART. " THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25701260 ↗
• MalfunctionJul 1, 2026Corroded

  IT WAS REPORTED THE DEVICE HAD ERROR CODE 600.6870.5. CUSTOMER IS REQUESTING AN INVESTIGATION INTO THE ROOT CAUSE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25674744 ↗
• MalfunctionJul 1, 2026Contamination; Corroded

  IT WAS REPORTED THE DEVICE HAD ERROR CODE 600.6870.5. CUSTOMER IS REQUESTING AN INVESTIGATION INTO THE ROOT CAUSE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25674743 ↗
• MalfunctionJul 1, 2026Contamination; Corroded

  IT WAS REPORTED THE DEVICE HAD ERROR CODE 600.6870.5. CUSTOMER IS REQUESTING AN INVESTIGATION INTO THE ROOT CAUSE. THERE WAS NO PATIENT INVOLVEMENT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25674742 ↗
• MalfunctionJun 19, 2026Break; Electrical /Electronic Property Problem

  IT WAS REPORTED THAT A FAILURE WAS OBSERVED DURING A PLANNED PREVENTATIVE MAINTENANCE, RECALL REMEDIATION, OR REPAIR ORDER SERVICE EVENT. [[SERVICE TYPE]];[INTERNAL POWER SUPPLY ISSUE]. THERE WAS NO REPORTED PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25560783 ↗
• MalfunctionJun 15, 2026Corroded

  IT WAS REPORTED THAT A FAILURE WAS OBSERVED DURING A PLANNED PREVENTATIVE MAINTENANCE, RECALL REMEDIATION, OR REPAIR ORDER SERVICE EVENT. [DEPOT REPAIR];[ALARMING WITH ERROR 133.6080]. THERE WAS NO REPORTED PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25501161 ↗
• MalfunctionJun 15, 2026Pumping Stopped; No Apparent Adverse Event

  IT WAS REPORTED THAT, DURING AN INFUSION, THE PUMP MODULES, OCCURRING ONE AT A TIME, BECAME UNABLE TO ACCEPT CHANGES TO THE VOLUME TO BE INFUSED AND SUBSEQUENTLY STOPPED RUNNING. THE PATIENT REMAINED HEMODYNAMICALLY STABLE. THERE WAS PATIENT INVOLVEMENT; HOWEVER, NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25498499 ↗
• MalfunctionJun 8, 2026Charging Problem

  IT WAS REPORTED THAT A FAILURE WAS OBSERVED DURING A PLANNED PREVENTATIVE MAINTENANCE, RECALL REMEDIATION, OR REPAIR ORDER SERVICE EVENT. [DEPOT REPAIR]; [DISPLAY ISSUE]. THERE WAS NO REPORTED PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25428803 ↗
• MalfunctionMay 29, 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]];[DISPLAYS A SYSTEM ERROR AND STARTS BEEPING CONTINUOUSLY DURING BATTERY OPTIMISATION]. THERE WAS NO REPORTED PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25331644 ↗
• MalfunctionMay 28, 2026Break

  IT WAS REPORTED THAT A FAILURE WAS OBSERVED DURING A PLANNED PREVENTATIVE MAINTENANCE, RECALL REMEDIATION, OR REPAIR ORDER SERVICE EVENT. [REPAIR MULTI-DEVICE];[DISPLAYING ERROR CODES.]. THERE WAS NO REPORTED PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25313510 ↗
• MalfunctionMay 18, 2026Battery Problem

  IT WAS REPORTED THAT A FAILURE WAS OBSERVED DURING A PLANNED PREVENTATIVE MAINTENANCE, RECALL REMEDIATION, OR REPAIR ORDER SERVICE EVENT. [[SERVICE TYPE]];[THE MAIN 8015 UNIT CANNOT CHARGE, SN (B)(6) ALSO MANUFACTURED 05/2025, ELECTRICAL SAFETY TEST PASSED, I CHANGED THE CABLE, SIMILAR EST RESULT, AC RECOGNISED BY PUMP, BATTERY/PCB MAY BE FAULTY.]. THERE WAS NO REPORTED PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25199478 ↗

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-0185-2024 · Sep 15, 2023 · Open, Classified
  BD Alaris Syringe Module, REF 8110
• Z-0184-2024 · Sep 15, 2023 · Open, Classified
  BD Alaris PCU REF 8015