Alaris™ Syringe Module, Model 8110 8100Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 10885403423208), received between Aug 3, 2022 and Aug 28, 2026 — classified as 14 malfunctions.

The most frequently reported specific device problem is “Break” (8 reports).

35 other recalls cover devices cleared under the same FDA submission (K133532); 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.

Most reported problems

Recent adverse event reports

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

• MalfunctionAug 28, 2026Excess Flow or Over-Infusion

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50491941 ↗
• MalfunctionAug 25, 2026Excess Flow or Over-Infusion

  It was reported that the device had over infusion of midazolam. Infusion was ordered to infuse at a rate of 9mL/hr for a total volume of 57mL. A "local unbranded 60mL syringe" was used. There was patient involvement, but harm is unknown.Additional details added from the Incident report received on 20-Aug-2026."On the day of incident, the patient was appeared to be struggling with the mechanical ventilator at ~11pm despite being prescribed high dose of sedation. Upon assessment, I checked the loaded Midazolam syringe in Alasis pump & observed that syringe contained volume of air, instead of the medication solution. There was no alarm even. Upon confirmation from evening staff nurse, she changed new loaded Midazolam 50ml syringe at 09:00pm.""patient was sedated with midazolam and morphine on full mode mechanical ventilation, despite of high dose sedation she was resisting ventilation."

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

  MAUDE report 50430018 ↗
• MalfunctionJun 2, 2026Communication or Transmission Problem

  IT WAS REPORTED THAT THE FOLLOWING ISSUE WAS OBSERVED ON THE DEVICE: "COMMUNICATION ERROR / DISCONNECTING." REPORTED PROBLEM CAUSE DESCRIPTION: "FAULTY IUI LEFT & RIGHT." HENCE, THE WORK PERFORMED IN THE DEVICE INCLUDES: "REPLACED LEFT AND RIGHT IUI CONNECTOR." THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25360903 ↗
• MalfunctionJan 23, 2026Break

  "IT WAS REPORTED THAT THE FOLLOWING ISSUE WAS OBSERVED ON THE DEVICE: "BROKEN." REPORTED PROBLEM CAUSE DESCRIPTION: "NONE PROVIDED." HENCE, THE WORK PERFORMED IN THE DEVICE INCLUDES: "UNIT CHECKED AND FOUND WEAR AND TEAR.NEED TO REPLACE - FRONT CASE - 49000218, REAR CASE - 49000823, HOUSING ASSY KIT - 49000213, FEMALE IUI - 147078-100, MALE IUI - 49000553, BARREL CLAMP-TC10006400, HOLDER TOP DICS - 147737-002, MYLAR GASKET - 147882-002."" THERE WAS NO PATIENT INVOLVEMENT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24159664 ↗
• MalfunctionJan 23, 2026Break

  IT WAS REPORTED THAT THE FOLLOWING ISSUE WAS OBSERVED ON THE DEVICE: "BROKEN." REPORTED PROBLEM CAUSE DESCRIPTION: "NONE PROVIDED." HENCE, THE WORK PERFORMED IN THE DEVICE INCLUDES: "UNIT CHECKED AND FOUND WEAR AND TEAR.NEED TO REPLACE - HOUSING ASSY KIT - (B)(6), BARREL CLAMP - (B)(4), FEMALE IUI - (B)(4), MALE IUI - (B)(4)." THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24159663 ↗
• MalfunctionNov 20, 2025Communication or Transmission Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT THE FOLLOWING ISSUE WAS OBSERVED ON THE DEVICE: "BROKEN." REPORTED PROBLEM CAUSE DESCRIPTION: "NONE PROVIDED." HENCE, THE WORK PERFORMED IN THE DEVICE INCLUDES: "UNIT CHECKED AND FOUND WEAR AND TEAR.NEED TO REPLACE - (FRONT CASE - (B)(4), QTY - (B)(4)) , (REAR CASE - (B)(4), QTY - (B)(4)),(BARREL CLAMP - (B)(4), QTY - (B)(4))(UI LEFT - (B)(4) QTY-(B)(4))(RIGHT IUI- (B)(4)- QTY (B)(4))." THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23604154 ↗
• MalfunctionSep 8, 2023Break; Failure to Align; Break; Failure to Align

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17709093 ↗
• MalfunctionSep 8, 2023Break; Device Sensing Problem; Break; Device Sensing Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17709019 ↗
• MalfunctionApr 12, 2023Break; Break

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16723708 ↗
• MalfunctionDec 30, 2022Break; 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. [[SERVICE TYPE]];[PLUNGER ISSUE]. THERE WAS NO REPORTED PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16076937 ↗
• MalfunctionNov 4, 2022Failure to Align; Failure to Align

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15734672 ↗
• MalfunctionOct 25, 2022Break; 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 15665712 ↗
• MalfunctionOct 25, 2022Corroded; 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 15665578 ↗
• MalfunctionAug 3, 2022Break; Crack; Break; Crack

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15154936 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K133532. 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-0186-2024 · Sep 15, 2023 · Open, Classified
  Alaris PCA Module 8120
• Z-1544-2021 · Mar 26, 2021 · Open, Classified
  Alaris Pump Module, Model 8100, serviced/repaired by Infusion Pump Repair with an impacted bezel repair part
• Z-1651-2021 · Mar 25, 2021 · Open, Classified
  Alaris Infusion Pump Module, Model 8100, serviced/repaired by The Biomed Guys, with the impacted bezel repair part, TIPA-8100-4410 / Alaris 8100 Bezel.
• Z-1375-2021 · Mar 24, 2021 · Open, Classified
  Aftermarket Alaris Infusion Pump Module Model 8100 Front Bezel, installed by Pacific Medical Group (DBA Avante Health Solutions)
• Z-1309-2021 · Mar 3, 2021 · Open, Classified
  BD Alaris Infusion Pump Module Model 8100 Pump Module Keypad; and Pump Module Door Assembly Replacement Kit with Pump Module Keypad, Parts: 49000239; 49000346; 49000438; 49000439.
• Z-1543-2021 · Feb 26, 2021 · Terminated
  Alaris Pump Module, Model 8100, serviced/repaired by Step-Har Medical with an impacted bezel repair part
• Z-1332-2021 · Feb 25, 2021 · Terminated
  Alaris Infusion Pump 8100 Bezel (plastic piece only), Part: TIPA-8100-4410
• Z-1331-2021 · Feb 25, 2021 · Terminated
  Alaris Infusion Pump Module, Model 8100, serviced/repaired by Tenacor with an impacted bezel repair part
• Z-2204-2021 · Feb 25, 2021 · Terminated
  Alaris Infusion Pump Module, Model 8100, serviced/repaired by Biomedical Equipment Service Co. (BMES) with an impacted bezel repair part TIPA-8100-4410
• Z-2909-2020 · Aug 4, 2020 · Open, Classified
  Alaris System PC Unit Model 8015
• Z-2910-2020 · Aug 4, 2020 · Open, Classified
  PC Unit Front Case with Keypad Replacement Kits: TC10008389 ASSY CASE FRONT W/KEYPAD 8015LS, TC10010217 ASSY FRT CASE W/ KEYPAD 8015 M2, TC10012515 ASSY FR CASE W/ KEYPAD 8015 M2,
• Z-2935-2020 · Aug 4, 2020 · Open, Classified
  BD Alaris System. The EtCO2 module is a capnograph indicated for continuous, noninvasive monitoring of end tidal carbon dioxide (EtCO2), fractional inspired carbon dioxide (FiCO2)

…and 20 more.