Alaris 8120 (UDI 10885403812002)Recalls & reported problems

Summary

The FDA's MAUDE database contains 14,640 adverse event reports that list this exact device (DI 10885403812002), received between Jul 25, 2018 and Sep 17, 2026 — classified as 4 deaths, 31 injuries, 14,605 malfunctions.

The most frequently reported specific device problem is “Break” (5,465 reports).

2 FDA recall records name this device's identifier, 1 still open.

3 other recalls cover devices cleared under the same FDA submission (K043299); 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. 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-3139-2024 · Root cause: Process control · Recall details · FDA record ↗

2. Nov 17, 2017Terminated

   The syringe plunger grippers may fail to automatically close around the syringe plunger press when the gripper control knob has been closed.

   Z-0323-2018 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 14,640 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 17, 2026Inaccurate Delivery

  It was reported that the Patient Controlled Analgesia Pump Module volume was too low. There was patient involvement, but no harm.Although requested, the customer did not provide further clarifying information and noted that the problem had been resolved.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50797640 ↗
• MalfunctionSep 4, 2026Circuit Failure; Computer Software Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50610920 ↗
• MalfunctionSep 1, 2026Break; Communication or Transmission Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50541739 ↗
• MalfunctionSep 1, 2026Break; Communication or Transmission Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50541737 ↗
• MalfunctionAug 7, 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]";"[Communication error]". There was no reported patient involvement.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50172412 ↗
• MalfunctionJul 29, 2026Break; Communication or Transmission Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50070585 ↗
• MalfunctionJun 18, 2026Corroded

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25544535 ↗
• MalfunctionMay 7, 2026Use of Device Problem; Inaccurate Delivery

  IT WAS INITIALLY REPORTED THAT "SOMETHING IS WRONG" WITH THE ALARIS DEVICES. THE CUSTOMER PROVIDED THE FOLLOWING INFORMATION ON 17 APRIL 2026. A PATIENT RECEIVED "100 TIMES" MORE THAN THE PRESCRIBED DOSE OF HYDROMORPHONE BETWEEN (B)(6) 2026 AND (B)(6) 2026 WHILE THE SPECIFIC TIME OF EVENT WAS APPROXIMATELY 1615 ON (B)(6) 2026. THE PATIENT RECEIVED MORE NARCOTIC MEDICATION THAN PRESCRIBED AND WAS SUSPECTED TO BE AN ENTRY ERROR. THE MEDICATION WAS HELD FOR SIX HOURS, AND THE PATIENT WAS HEAVILY SEDATED FOR A PERIOD OF TWO DAYS. THE CUSTOMER ALSO SPECIFIED THAT THEY WERE NOT REPORTING A PUMP MALFUNCTION. THE CUSTOMER WAS REQUESTING THE FOLLOWING INFORMATION FROM THE INVESTIGATION: "WE NEED ALL MANUALLY ENTERED PUMP CHANGES FOR: MEDICATION TYPE, INFUSION RATE, VOLUME AND DOSE CONCENTRATION, KEY ENTRY FOR PCA, CLEARING OF VOLUME INFUSED, BETWEEN (B)(6) 2026 AND (B)(6) 2026".

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 25110220 ↗
• MalfunctionApr 30, 2026Corroded; Inaccurate Delivery

  IT WAS REPORTED THAT A FAILURE WAS OBSERVED DURING A PLANNED PREVENTATIVE MAINTENANCE, RECALL REMEDIATION, OR REPAIR ORDER SERVICE EVENT. [[SERVICE TYPE]];[POTENTIOMETER ISSUE. - PCA PUMP OUT OF CALIBRATION COUNTING BACKWARDS SO THE TALLY FOR THE 24 HOURS IS NOW INACCURATE.]. THERE WAS NO REPORTED PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25043330 ↗
• MalfunctionApr 28, 2026Device Alarm System

  IT WAS REPORTED THAT A FAILURE WAS OBSERVED DURING A PLANNED PREVENTATIVE MAINTENANCE, RECALL REMEDIATION, OR REPAIR ORDER SERVICE EVENT. [[SERVICE TYPE]];[SYRINGE CALIBRATION REQUIRED - SEE PICTURE]. THERE WAS NO REPORTED PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25014527 ↗
• MalfunctionApr 24, 2026Corroded; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT THE DEVICE HAD BOTTOM DOES NOT CLIP TO ATTACHMENT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24978949 ↗
• MalfunctionApr 21, 2026Corroded; Calibration Problem

  IT WAS REPORTED THAT A FAILURE WAS OBSERVED DURING A PLANNED PREVENTATIVE MAINTENANCE, RECALL REMEDIATION, OR REPAIR ORDER SERVICE EVENT. [[SERVICE TYPE]];[PLUNGER FORCE CALIBRATION FAILED (ERROR CODE: 351.6660 ¿ LINEAR POSITION SENSOR)]. THERE WAS NO REPORTED PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24937007 ↗
• MalfunctionApr 21, 2026Computer Software Problem

  IT WAS REPORTED THAT THE DEVICE WILL NOT COMMUNICATE WITH AN 8015 DEVICE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24935005 ↗
• MalfunctionApr 9, 2026False Alarm

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24825397 ↗
• MalfunctionMar 13, 2026Use of Device Problem

  ON (B)(6) 2025, DURING A PATIENT CONTROLLED ANALGESIA (PCA) INFUSION OF HYDROMORPHONE, A CLINICIAN REPORTED THAT INFUSION HISTORY FROM 07:15 TO 16:55 APPEARED ERASED WHEN REPLACING THE MEDICATION CARTRIDGE AT 16:55. A PRELIMINARY REVIEW BY A BD INTEROPERABILITY CONSULTANT CONFIRMED THAT THE INITIAL SYRINGE WAS PROGRAMMED USING GUARDRAILS HYDROMORPHONE CUSTOM (DRUG ID 472). WHEN THE SECOND SYRINGE WAS INSTALLED, THE CLINICIAN SELECTED GUARDRAILS HYDROMORPHONE (DRUG ID 477). BECAUSE THE DRUG ID CHANGED BETWEEN CARTRIDGES, THE SYSTEM BEHAVED AS DESIGNED AND TREATED THE PROGRAMMING AS A NEW DRUG EVENT, WHICH CLEARS THE PRIOR INFUSION HISTORY. CUSTOMER CONFIRMED NO ADVERSE EVENT OCCURRED AND CONFIRMED EVENT WAS ATTRIBUTED TO A GUARDRAILS WORKFLOW ISSUE. THERE WAS PATIENT INVOLVEMENT WITH NO HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24588121 ↗
• MalfunctionFeb 23, 2026Failure to Read Input Signal

  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 MULTIPLE ERRORS]. THERE WAS NO REPORTED PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24412641 ↗
• MalfunctionFeb 11, 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. \[\[SERVICE TYPE]"]";\[PLUNGER HEAD STUCK]". THERE WAS NO REPORTED PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24312557 ↗
• MalfunctionFeb 11, 2026Corroded

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24312556 ↗
• MalfunctionFeb 11, 2026Corroded; Calibration Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24312200 ↗
• MalfunctionFeb 6, 2026Calibration Problem

  IT WAS REPORTED THAT THE DEVICE HAD FAILED PM - PLUNGER FORCE CALIBRATION. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24276395 ↗
• MalfunctionJan 30, 2026Break; Crack; Use of Device Problem; Insufficient Flow or Under Infusion; Device Markings/Labelling Problem

  IT WAS REPORTED AN UNDER INFUSION. PER REPORT, "AT SHIFT CHANGE THE ONCOMING CLINICIAN NOTICED THE MEDICATION WAS NEVER DELIVERED TO THE PATIENT DURING THE NIGHT. THE PCA PUMP RECORDED A DELIVERY OF 11 DOSES." THERE WAS PATIENT INVOLVEMENT BUT UNKNOWN HARM. ALTHOUGH REQUESTED NO ADDITIONAL INFORMATION WILL BE PROVIDED BY THE CUSTOMER.

  Patient problems: Insufficient Information

  MAUDE report 24219800 ↗
• MalfunctionJan 27, 2026Break; Corroded; Display Difficult to Read; 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]]; [CRACK IN FRONT BEZEL]. THERE WAS NO REPORTED PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24187391 ↗
• MalfunctionJan 19, 2026Failure to Read Input Signal

  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 FAILING PLUNGER POSITION VERIFICATION.NO PATIENT INVOLVEMENT - OBSERVED DURING ROUTINE PREVENTATIVE MAINTENANCE.]. THERE WAS NO REPORTED PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24108151 ↗
• MalfunctionJan 5, 2026Contamination; Insufficient Flow or Under Infusion; Naturally Worn

  IT WAS REPORTED THAT THE PATIENT CONTROLLED ANALGESIA (PCA) PUMP MODULE CLEARED TOTAL DRUG FOR ROUGHLY 3MG WHEN IT SHOULD HAVE BEEN 6MG ON 13DEC2025. THERE WAS PATIENT INVOLVEMENT, BUT THE OUTCOME IS UNKNOWN. PER THE CUSTOMER'S INTERNAL TESTING: THEY RAN A PREVENTATIVE MAINTENANCE IN THE SYSTEM MAINTENANCE SOFTWARE, IT PASSED WITH NO ISSUES, SO WHEN THEY RAN A MANUAL INFUSION, THE PUMP MODULE WAS SUPPOSED TO HAVE INFUSED 1ML BUT ONLY .75ML WAS INFUSED. A SOFTWARE CALIBRATION WAS RUN AND PASSED. AFTER THE SOFTWARE CALIBRATION, THE PCU WAS CONNECTED TO THE PCA AND INDICATED THAT A CALIBRATION WAS NEEDED. THE SOFTWARE CALIBRATION WAS RUN AGAIN AND PASSED, BUT THEN THEY GOT THE SAME ERROR. AFTER PULLING THE ERROR LOG ON 15DEC2025, IT WAS FOUND THAT THERE WAS AN ERROR CODE 351.6740.0 SYR_NUT_BECAME_DISENGAGED. THE CUSTOMER LATER PROVIDED THE FOLLOWING INFORMATION: "PCA SYRINGE WAS CHANGED AT 0846 AND AGAIN AT 1443. AT 1443 PCA TOTAL DRUG CLEARED FOR 3.04MG. TOTAL DRUG SHOULD HAVE BEEN CLOSER TO 6MG. HYDROMORPHONE (0.2 MG/ML) NO TITRATION. PCA WAS ON A CONTINUOUS 1MG/HR DOSE WITH A .2MG DOSE EVERY 8 MINUTES. SYRINGE CHANGE SHOULD HAVE OCCURRED EVERY 6 HOURS BUT SYRINGE LASTED A TOTAL OF

  Patient problems: Insufficient Information

  MAUDE report 23954599 ↗
• MalfunctionDec 25, 2025Break; Corroded; Display Difficult to Read; Break; Corroded; Display Difficult to Read

  IT WAS REPORTED THAT A FAILURE WAS OBSERVED DURING A PLANNED PREVENTATIVE MAINTENANCE, RECALL REMEDIATION, OR REPAIR ORDER SERVICE EVENT. [DEPOT REPAIR];[ISSUE: BROKEN PUMP (DAMAGED FROINT BEZEL, BACK COVER, HADLES, DOOR)]. THERE WAS NO REPORTED PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23892133 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K043299. One submission often covers many models, so check the product and lot details in each record.

• Z-2882-2020 · Aug 4, 2020 · Open, Classified
  BD Alaris System; Alaris Syringe Module Model 8110; BD Alaris System; Alaris PCA Module Model 8120; BD Alaris System; Syringe/PCA Sizer Sensor Replacement Kit, P/N 122278652
• Z-1711-2008 · Mar 5, 2008 · Terminated
  Grey 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)* (
• Z-1712-2008 · Mar 5, 2008 · Terminated
  U9 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