Ambu® SPUR® II Pediatric Resuscitator 531600051Recalls & reported problems
Ambu A/S · w/ Expiratory Filter, Manometer & PEEP valve · Class 2
All models of Ambu SPUR II Pediatric Resuscitator (26)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 10
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 05707480163441), received between Jun 3, 2025 and Jul 2, 2025 — classified as 10 malfunctions.
The most frequently reported specific device problem is “Blocked Connection” (10 reports).
1 FDA recall record name this device's identifier, 1 still open.
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.
Reports received per month
Recalls naming this device
- Jul 9, 2025Class IOpen, Classified
Potential for the manometer port being blocked rendering the manometer non-functional.
Z-2181-2025 · Root cause: Equipment maintenance · Recall details · FDA record ↗
Most reported problems
Device problems
- Blocked Connection10
Patient problems
- No Clinical Signs, Symptoms or Conditions10
Recent adverse event reports
The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 2, 2025Blocked Connection; Blocked Connection
CUSTOMER REPORTED THAT THERE WAS NO HOLE FOR THE MANOMETER. THE MANOMETER PORT WAS BLOCKED, RENDERING THE MANOMETER NON-FUNCTIONAL. THERE WAS NO PATIENT INVOLVEMENT AS THE DEFECT WAS OBSERVED PRIOR TO USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22382268 ↗MalfunctionJul 2, 2025Blocked Connection; Blocked Connection
CUSTOMER REPORTED THAT THERE WAS NO HOLE FOR THE MANOMETER. THE MANOMETER PORT WAS BLOCKED, RENDERING THE MANOMETER NON-FUNCTIONAL. THERE WAS NOT PATIENT INVOLVEMENT AS THE DEFECT WAS OBSERVED PRIOR TO USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22380719 ↗MalfunctionJun 17, 2025Blocked Connection; Blocked Connection
AN AMBU SALES REPRESENTATIVE WAS CHECKING HIS SPUR II STOCK AND DETECTED 3 PIECES OF SPUR II WITH OCCLUDDED MANOMETER PORT, RENDERING THE MANOMETER NON-FUNCTIONAL. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22236633 ↗MalfunctionJun 17, 2025Blocked Connection; Blocked Connection
AN AMBU SALES REPRESENTATIVE WAS CHECKING HIS SPUR II STOCK AND DETECTED 3 PIECES OF SPUR II WITH OCCLUDED MANOMETER PORT, RENDERING THE MANOMETER NON-FUNCTIONAL. THERE WAS NO PATIENT INVOLVEMENT OR HARM REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22227814 ↗MalfunctionJun 11, 2025Blocked Connection; Blocked Connection
THE CUSTOMER REPORTED THAT SPUR II WITH BLOCKED MANOMETER PORT WAS FOUND. THE MANOMETER PORT BEING BLOCKED, DOES NOT ALLOW AIR TO FLOW THROUGH, RENDERING THE MANOMETER NON-FUNCTIONAL. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22187082 ↗MalfunctionJun 11, 2025Blocked Connection; Blocked Connection
A CUSTOMER REPORTED SPUR II WITH BLOCKED MANOMETER PORT WAS FOUND. THE AFFECTED BAGS WERE PULLED. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22186696 ↗MalfunctionJun 11, 2025Blocked Connection; Blocked Connection
THE CUSTOMER REPORTED THAT A THIRD LOT OF SPUR II WITH BLOCKED MANOMETER PORT WAS FOUND. THE MANOMETER PORT BEING BLOCKED, DOES NOT ALLOW AIR TO FLOW THROUGH, RENDERING THE MANOMETER NON-FUNCTIONAL. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22183786 ↗MalfunctionJun 11, 2025Blocked Connection; Blocked Connection
A CUSTOMER REPORTED THAT A SECOND LOT FOR SPUR II WITH BLOCKED MANOMETER PORT WAS FOUND. THE AFFECTED BAGS WERE PULLED. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22183766 ↗MalfunctionJun 3, 2025Blocked Connection; Blocked Connection
CUSTOMER WAS CHECKING THE INVENTORY BEFORE THE SPUR II PRODUCT WENT INTO CIRCULATION. A DEFECT IN SEVERAL AMBU PEDIATRIC RESUSCITATION BAGS, SPECIFICALLY IN THE PRESSURE MANOMETER PORT, WAS DETECTED. THE MANOMETER PORT BEING OBSTRUCTED, RENDERED THE MANOMETER NONFUNCTIONAL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22135566 ↗MalfunctionJun 3, 2025Blocked Connection; Blocked Connection
CUSTOMER WAS CHECKING THE INVENTORY BEFORE THE SPUR II PRODUCT WENT INTO CIRCULATION. A DEFECT IN SEVERAL AMBU PEDIATRIC RESUSCITATION BAGS, SPECIFICALLY IN THE PRESSURE MANOMETER PORT, WAS DETECTED. THE MANOMETER PORT BEING OBSTRUCTED, RENDERED THE MANOMETER NONFUNCTIONAL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22134710 ↗
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- Ambu® SPUR® II Adult Resuscitator 523611051Ambu A/S · Cardiopulmonary resuscitation aid kit1 recall3 reports
- AirLife™ 2K8017Airlife · Cardiopulmonary resuscitation aid kit1 recall1 death2 reports
- AirLife™ 2K8004FAirlife · Cardiopulmonary resuscitation aid kit1 recall1 report
- Ambu® SPUR® II Pediatric Resuscitator 530213031Ambu A/S · Cardiopulmonary resuscitation aid kit1 recall0 reports
- Ambu® SPUR® II Pediatric Resuscitator 530613071Ambu A/S · Cardiopulmonary resuscitation aid kit1 recall0 reports
- Ambu® SPUR® II Adult Resuscitator 524611031Ambu A/S · Cardiopulmonary resuscitation aid kit1 recall0 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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