Ambu® SPUR® II Adult Resuscitator 520611000Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 05707480151776), received between Feb 17, 2023 and May 22, 2026 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Component Missing” (6 reports).

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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 22, 2026Component Missing

  THE CUSTOMER STATED WHEN HE OPENED THE PLASTIC BAG FOR PATIENT USE THERE WAS NO MASK INSIDE THE BAG. NO IMPACT TO PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25257619 ↗
• MalfunctionMay 22, 2026Component Missing

  THE CUSTOMER STATED WHEN HE OPENED THE PLASTIC BAG FOR PATIENT USE THERE WAS NO MASK INSIDE THE BAG. NO IMPACT TO PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25251195 ↗
• MalfunctionApr 8, 2026Component Missing

  AN AMBU SPUR II WAS IDENTIFIED AS DEFECTIVE SUPPLY. THE PRODUCT SHOULD BE SUPPLIED WITH MASK FOR BAGGING PATIENTS. FACEMASK WAS NOT INCLUDED, THIS SUPPLY DID NOT REACH A PATIENT, THIS IS THE SECOND TIME THIS HAS OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24820793 ↗
• MalfunctionApr 8, 2026Component Missing

  AN AMBU SPUR II WAS IDENTIFIED AS DEFECTIVE SUPPLY. THE PRODUCT SHOULD BE SUPPLIED WITH MASK FOR BAGGING PATIENTS. FACEMASK WAS NOT INCLUDED, THIS SUPPLY DID NOT REACH A PATIENT, THIS IS THE SECOND TIME THIS HAS OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24814477 ↗
• MalfunctionFeb 13, 2026Component Missing

  CUSTOMER HAD A SEALED AMBU SPUR II ADULT RESUSCITATOR THAT DID NOT HAVE A MASK IN THE SEALED PACKAGE. PATIENT CONDITION WAS NOT AFFECTED, ATTEMPTED TO BE USED ON A PATIENT, BUT THE NURSE WAS UNABLE TO DUE TO THE MISSING MASK. SHE HAD TO GO GET ANOTHER AMBU BAG FROM A DIFFERENT CRASH CART. THERE WAS A SLIGHT DELAY IN PATIENT CARE, BUT THE PATIENT'S CARE WAS NOT AFFECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24336841 ↗
• MalfunctionFeb 13, 2026Component Missing

  CUSTOMER HAD A SEALED AMBU SPUR II ADULT RESUSCITATOR THAT DID NOT HAVE A MASK IN THE SEALED PACKAGE. PATIENT CONDITION WAS NOT AFFECTED, ATTEMPTED TO BE USED ON A PATIENT, BUT THE NURSE WAS UNABLE TO DUE TO THE MISSING MASK. SHE HAD TO GO GET ANOTHER AMBU BAG FROM A DIFFERENT CRASH CART. THERE WAS A SLIGHT DELAY IN PATIENT CARE, BUT THE PATIENT'S CARE WAS NOT AFFECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24330063 ↗
• MalfunctionFeb 17, 2023Inflation Problem; Infusion or Flow Problem; Inflation Problem; Infusion or Flow Problem

  AMBU BAG DEFLATED AND UNABLE TO GET THE RESUSCITATOR TO EXPAND CORRECTLY TO BE ABLE TO DELIVER AN ADEQUATE FLOW. THE HEALTH PROFESSIONALS UTILIZED ANOTHER AMBU BAG. PATIENT DID NOT SURVIVE THE CODE. ACCORDING TO HEALTH CARE PROFESSIONAL THE PATIENT'S DEMISE WAS NOT RELATED TO THE POOR PERFORMANCE OF THE AMBU BAG, BUT RATHER DUE TO COMORBIDITIES AND A HGB OF 5.

  Patient problems: Respiratory Failure

  MAUDE report 16395786 ↗