Alaris 8220Recalls & reported problems

Summary

The FDA's MAUDE database contains 77 adverse event reports that list this exact device (DI 10885403822018), received between Nov 12, 2018 and Feb 22, 2023 — classified as 1 injury, 76 malfunctions.

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

2 other recalls cover devices cleared under the same FDA submission (K010966); 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.

Most reported problems

Recent adverse event reports

The 25 most recent of 77 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 22, 2023Circuit Failure; Circuit Failure

  IT WAS REPORTED THAT THE DEVICE HAD UNKNOWN ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16416208 ↗
• MalfunctionDec 26, 2022No Apparent Adverse Event; Communication or Transmission Problem; No Apparent Adverse Event

  (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16046236 ↗
• MalfunctionNov 15, 2022Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT THE BD ULTRA-FINE¿ PEN NEEDLE WAS UNABLE TO DELIVER INSULIN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER REPORTED WHILE INJECTING THE NEEDLE FOUND TO NOT HAVE A HOLE AND DID NOT ALLOW THE INSULIN TO FLOW THRU IT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15801500 ↗
• MalfunctionOct 21, 2022Break; Crack; Break; Crack

  IT WAS REPORTED THAT THE DEVICE FAILED SPO2 CABLE TEST. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15649648 ↗
• MalfunctionOct 20, 2022Communication or Transmission Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT THE DEVICE HAD A CHANNEL ERROR. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15638007 ↗
• MalfunctionJul 29, 2022Communication or Transmission Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT THE DEVICE HAD ERROR 471.6211. THE INFORMATION ON PATIENT INVOLVEMENT IS UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 15127468 ↗
• MalfunctionJul 20, 2022Communication or Transmission Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT THE DEVICE DISPLAYED AN ERROR CODE 471.6211 AND ALSO HAD CHANNEL ERROR DURING PREVENTIVE MAINTENANCE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15071189 ↗
• MalfunctionMar 23, 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 13867265 ↗
• MalfunctionFeb 22, 2022Corroded; Missing Information; Corroded; Missing Information

  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 13577388 ↗
• MalfunctionFeb 22, 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 13577285 ↗
• MalfunctionFeb 22, 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 13577283 ↗
• MalfunctionJan 6, 2022Communication or Transmission Problem; Communication or Transmission Problem

  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 13175485 ↗
• MalfunctionJan 6, 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 13175243 ↗
• MalfunctionJan 4, 2022Crack; 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 13150485 ↗
• MalfunctionJan 3, 2022Crack; 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 13146680 ↗
• MalfunctionDec 31, 2021Crack; 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 13124022 ↗
• MalfunctionDec 16, 2021Corroded; 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 13016736 ↗
• MalfunctionDec 16, 2021Corroded; 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 13016675 ↗
• MalfunctionDec 16, 2021Corroded; 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 13016669 ↗
• MalfunctionDec 16, 2021Corroded; 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 13016664 ↗
• MalfunctionDec 16, 2021Corroded; 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 13016650 ↗
• MalfunctionDec 16, 2021Corroded; 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 13016605 ↗
• MalfunctionDec 16, 2021Corroded; 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 13015615 ↗
• MalfunctionDec 16, 2021Corroded; 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 13015580 ↗
• MalfunctionDec 15, 2021Corroded; 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 13008990 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K010966. One submission often covers many models, so check the product and lot details in each record.

• 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