Ambu SPUR II Pediatric ResuscitatorRecalls & reported problems across all models
Ambu A/S · 26 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names at least one Ambu SPUR II Pediatric Resuscitator model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 10
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls
- 1
We found 26 models of Ambu SPUR II Pediatric Resuscitator by Ambu A/S in the FDA's device registry (GUDID). Together they are named in 10 adverse event reports in the FDA's MAUDE database, 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 at least one of these models by its device 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Ambu SPUR II Pediatric Resuscitator recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Jul 9, 2025Open, Classified
Potential for the manometer port being blocked rendering the manometer non-functional.
Z-2181-2025 · Root cause: Equipment maintenance · names 26 of these models · Recall details · FDA record ↗
Most reported Ambu SPUR II Pediatric Resuscitator problems
Device problems
- Blocked Connection10
Patient problems
- No Clinical Signs, Symptoms or Conditions10
Ambu SPUR II Pediatric Resuscitator models
26 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Ambu® SPUR® II Pediatric Resuscitator 531600051Cardiopulmonary resuscitation aid kit1 recall10 reports
- Ambu® SPUR® II Pediatric Resuscitator 530200016Cardiopulmonary resuscitation aid kit1 recall0 reports
- Ambu® SPUR® II Pediatric Resuscitator 530212001Cardiopulmonary resuscitation aid kit1 recall0 reports
- Ambu® SPUR® II Pediatric Resuscitator 530213030Cardiopulmonary resuscitation aid kit1 recall0 reports
- Ambu® SPUR® II Pediatric Resuscitator 530613031Cardiopulmonary resuscitation aid kit1 recall0 reports
- Ambu® SPUR® II Pediatric Resuscitator 530613071Cardiopulmonary resuscitation aid kit1 recall0 reports
- Ambu® SPUR® II Pediatric Resuscitator 530613831Cardiopulmonary resuscitation aid kit1 recall0 reports
- Ambu® SPUR® II Pediatric Resuscitator 530614017Cardiopulmonary resuscitation aid kit1 recall0 reports
- Ambu® SPUR® II Pediatric Resuscitator 530614030Cardiopulmonary resuscitation aid kit1 recall0 reports
- Ambu® SPUR® II Pediatric Resuscitator 530614800Cardiopulmonary resuscitation aid kit1 recall0 reports
- Ambu® SPUR® II Pediatric Resuscitator 530615030Cardiopulmonary resuscitation aid kit1 recall0 reports
- Ambu® SPUR® II Pediatric Resuscitator 530619031Cardiopulmonary resuscitation aid kit1 recall0 reports
- Ambu® SPUR® II Pediatric Resuscitator 531613031Cardiopulmonary resuscitation aid kit1 recall0 reports
- Ambu® SPUR® II Pediatric Resuscitator 531613047Cardiopulmonary resuscitation aid kit1 recall0 reports
- Ambu® SPUR® II Pediatric Resuscitator 531614026Cardiopulmonary resuscitation aid kit1 recall0 reports
- Ambu® SPUR® II Pediatric Resuscitator 530212000Cardiopulmonary resuscitation aid kit1 recall0 reports
- Ambu® SPUR® II Pediatric Resuscitator 530213000Cardiopulmonary resuscitation aid kit1 recall0 reports
- Ambu® SPUR® II Pediatric Resuscitator 530213001Cardiopulmonary resuscitation aid kit1 recall0 reports
- Ambu® SPUR® II Pediatric Resuscitator 530213011Cardiopulmonary resuscitation aid kit1 recall0 reports
- Ambu® SPUR® II Pediatric Resuscitator 530213031Cardiopulmonary resuscitation aid kit1 recall0 reports
- Ambu® SPUR® II Pediatric Resuscitator 530214000Cardiopulmonary resuscitation aid kit1 recall0 reports
- Ambu® SPUR® II Pediatric Resuscitator 530613000Cardiopulmonary resuscitation aid kit1 recall0 reports
- Ambu® SPUR® II Pediatric Resuscitator 531613000Cardiopulmonary resuscitation aid kit1 recall0 reports
- Ambu® SPUR® II Pediatric Resuscitator 531613001Cardiopulmonary resuscitation aid kit1 recall0 reports
- Ambu® SPUR® II Pediatric Resuscitator 531613010Cardiopulmonary resuscitation aid kit1 recall0 reports
- Ambu® SPUR® II Pediatric Resuscitator 530213000BCardiopulmonary resuscitation aid kit1 recall0 reports
Recent Ambu SPUR II Pediatric Resuscitator adverse event reports
The 10 most recent reports across all models, 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 ↗
Other Ambu A/S products
All Ambu A/S devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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