Alaris 8120 (UDI 10885403812026)Recalls & reported problems

Summary

The FDA's MAUDE database contains 70 adverse event reports that list this exact device (DI 10885403812026), received between Dec 8, 2020 and May 15, 2026 — classified as 70 malfunctions.

The most frequently reported specific device problem is “Break” (29 reports).

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

4 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 18, 2026.

Recalls naming this device

1. Aug 15, 2024Class IIOpen, 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-3139-2024 · Root cause: Process control · Recall details · FDA record ↗

2. Sep 15, 2023Class IOpen, Classified

   Alaris PCA Module 8120, Patient Controlled Analgesia infusion pump: compatible syringes labeling contains syringes that have not been validated.

   Z-0184-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 70 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 15, 2026Corroded

  IT WAS REPORTED THAT A FAILURE WAS OBSERVED DURING A PLANNED PREVENTATIVE MAINTENANCE, RECALL REMEDIATION, OR REPAIR ORDER SERVICE EVENT. [FIELD SERVICE];[LEFT IUI CORRODED]. THERE WAS NO REPORTED PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25180163 ↗
• MalfunctionJan 6, 2026False Alarm

  IT WAS REPORTED THAT A FAILURE WAS OBSERVED DURING A PLANNED PREVENTATIVE MAINTENANCE, RECALL REMEDIATION, OR REPAIR ORDER SERVICE EVENT. [[SERVICE TYPE]];[PCA MODULE DETECTS THE VOLUME LEFT IN THE SYRINGE PROPERLY, BUT AS SOON AS IT STARTS INFUSING, THE PUMP IS ALARMING LOW VOLUME LEFT]. THERE WAS NO REPORTED PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23972563 ↗
• MalfunctionOct 3, 2025Break; Physical Resistance/Sticking; Break; 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];[PCA IS JAMMED AND IS VERY HARD TO RELEASE THE PCA FROM THE 8015 UNIT.]. THERE WAS NO REPORTED PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23208953 ↗
• MalfunctionJun 26, 2025Circuit Failure; Circuit Failure

  IT WAS REPORTED THAT A FAILURE WAS OBSERVED DURING A PLANNED PREVENTATIVE MAINTENANCE, RECALL REMEDIATION, OR REPAIR ORDER SERVICE EVENT. [DEPOT REPAIR];[NOT TURNING ON]. THERE WAS NO REPORTED PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22338843 ↗
• MalfunctionJun 3, 2025Corroded; Corroded

  IT WAS REPORTED THAT A FAILURE WAS OBSERVED DURING A PLANNED PREVENTATIVE MAINTENANCE, RECALL REMEDIATION, OR REPAIR ORDER SERVICE EVENT. [FIELD SERVICE]; [PLUNGER FORCE ACCURACY FAILED]. THERE WAS NO REPORTED PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22130736 ↗
• MalfunctionAug 9, 2024Device Alarm System; Device Alarm System

  IT WAS REPORTED THAT A FAILURE WAS OBSERVED DURING A PLANNED PREVENTATIVE MAINTENANCE, RECALL REMEDIATION, OR REPAIR ORDER SERVICE EVENT. [[SERVICE TYPE]];[CURRENTLY HAVING 353.6650 AND 351.6660 BOTH LINEAR POSITION ISSUE.]. THERE WAS NO REPORTED PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19947667 ↗
• MalfunctionJul 5, 2024Calibration Problem; Physical Resistance/Sticking; Calibration Problem; Physical Resistance/Sticking

  IT WAS REPORTED THAT A FAILURE WAS OBSERVED DURING A PLANNED PREVENTATIVE MAINTENANCE, RECALL REMEDIATION, OR REPAIR ORDER SERVICE EVENT. [[SERVICE TYPE]];[CAN'T CALIBRATE PLUNGER POSITION]. THERE WAS NO REPORTED PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19677714 ↗
• MalfunctionJun 13, 2024Break; Break

  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 REPLACED IUI CONNECTOR]. THERE WAS NO REPORTED PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19529539 ↗
• MalfunctionMar 27, 2024Break; Corroded; Break; Corroded

  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 18989855 ↗
• MalfunctionMar 27, 2024Break; Break

  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 18988691 ↗
• MalfunctionMar 20, 2024Break; Break

  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 18944533 ↗
• MalfunctionMar 20, 2024Break; Break

  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 18944385 ↗
• MalfunctionMar 6, 2024Crack; Crack

  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 18849158 ↗
• MalfunctionMar 6, 2024Break; Crack; Communication or Transmission Problem; Device Markings/Labelling Problem; Break; Crack; Communication or Transmission Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT THE DEVICE DISPLAYED ERROR CODES 358.2000 , 357.6000 AND HAD PHYSICAL DAMAGE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18848397 ↗
• MalfunctionJan 10, 2024Break; Contamination; Device Markings/Labelling Problem; Break; Contamination; Device Markings/Labelling Problem

  IT WAS REPORTED THAT THE DEVICE HAD CRACKED, BROKEN AND MISSING PIECE OF LOWER DOOR. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18485149 ↗
• MalfunctionJan 9, 2024Contamination; Use of Device Problem; Appropriate Device Problem Term/Code Not Available; Contamination; Use of Device Problem; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THE PRIMING FEATURE WAS "GRAYED OUT" PCA PUMP. THE CLINICIAN ALSO REPORTED THAT THE DEVICE "RECORDS TWO DECIMAL PLACES THAT "DOESN'T ADD UP WITH MAR (MEDICATION ADMINISTRATION RECORD). CLINICIAN USED THE EXAMPLE "THE PUMP WILL STATE 2.25 HOWEVER THE MAR WILL STATE 2.3. EDUCATION WAS PROVIDED TO THE CLINICIAN THAT THE DEVICE IS DESIGNED TO ROUND TO THE NEAREST HUNDREDTH, WHICH WOULD RESULT IN TWO DECIMAL PLACES. THERE WAS PATIENT INVOLVEMENT BUT NO HARM. BD HAS LEARNED ADDITIONAL INFORMATION. BD CLINICAL PRACTICE CONSULTANT (CPC) WENT ONSITE, AND IT WAS REPORTED TO THEM THAT THE CLINICIANS STATED COUNTS MAY BE OFF DUE TO DOCUMENTATION ISSUES BY THE CLINICIAN. FOR EXAMPLE, IF USING A 20ML SYRINGE THEY WOULD PUT 20ML ON THEIR FLOW SHEET, BUT THE SYRINGE READ 19.7ML AT START-UP. THEN THEY WOULD DOCUMENT EVERY HOUR, BUT THEY WOULD DOCUMENT ¿1ML¿ EVEN IF IT WAS ACTUALLY 1.3ML BECAUSE THEY DID NOT ASSESS THE PUMP EXACTLY AN HOUR AFTER THE LAST ASSESSMENT. ONE CLINICIAN ALSO STATED THEY HAVE TO STOP THE INFUSION FOR MEDICATION ADMINISTRATION AND THAT MAYBE THE CLINICIANS ARE NOT ¿DOING THE RIGHT MATH¿. THE NICU USES SYRINGE PUMPS IN A LOCK BOX INSTEAD OF PCA PUMPS, THEY ¿DO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18473715 ↗
• MalfunctionDec 26, 2023Device Alarm System; Device Alarm System

  IT WAS REPORTED THAT THE DEVICE HAD CHANNEL ERROR 5-13-1504. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18391816 ↗
• MalfunctionNov 28, 2023Contamination; Contamination

  IT WAS REPORTED THAT THE DEVICE HAD WOULD NOT REGISTER THAT BUTTON HAS BEEN PRESSED ON THE PCA HANDSET, VERIFIED WITH A PCA HANDSET KNOWN TO BE FUNCTIONAL. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18219281 ↗
• MalfunctionNov 23, 2023Physical Resistance/Sticking; Physical Resistance/Sticking

  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 18199297 ↗
• MalfunctionNov 23, 2023Break; Break

  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 18198955 ↗
• MalfunctionNov 2, 2023Physical Resistance/Sticking; Physical Resistance/Sticking

  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 18058971 ↗
• MalfunctionOct 6, 2023Break; Crack; Deformation Due to Compressive Stress; Device Markings/Labelling Problem; Break; Crack; Deformation Due to Compressive Stress; Device Markings/Labelling Problem

  IT WAS REPORTED THAT THE DEVICE HAD CRACKED FRONT AND REAR CASE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17891196 ↗
• MalfunctionAug 24, 2023Break; Break

  IT WAS REPORTED THAT THE DEVICE HAD PHYSICAL DAMAGE WITH CRACKED FRONT CASE AT LEFT CORNER BY THE LENS, CRACKED REAR CASE NEAR THE RELEASE LATCH AND ON THE BOTTOM RIGHT CORNER ALONG WITH ISOLATION RIB DAMAGE ON RIGHT IUI. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17617708 ↗
• MalfunctionJul 13, 2023Break; Contamination; Crack; Device Markings/Labelling Problem; Break; Contamination; Crack; Device Markings/Labelling Problem

  IT WAS REPORTED THAT THE DEVICE HAD CRACKED FRONT CASE NEAR LENS AND REAR CASE ON THE BOTTOM RIGHT CORNER. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17315114 ↗
• MalfunctionJun 8, 2023Break; Break

  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 17095167 ↗

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, Classified
  BD Alaris" System with Guardrails" Suite MX with Point of Care Unit
• Z-0186-2024 · Sep 15, 2023 · Open, Classified
  Alaris PCA Module 8120
• Z-0185-2024 · Sep 15, 2023 · Open, Classified
  BD Alaris Syringe Module, REF 8110
• Z-1192-2023 · Jan 24, 2023 · Open, Classified
  Alaris 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