FDAJuly 9, 2025device
Ambu SPUR II Labeled as the following: 1 SPUR II Adult Resuscitator, Adult, Catalog Number: 523211000 2 SPUR II Adult Resuscitator w/Mercury Filter, Adult, Catalog Number: 523611051 3 SPUR II Adult Resuscitator, Single Patient Use Resuscitator, Adult, Catalog Number: 523611057 4 SPUR II Adult Res...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Potential for the manometer port being blocked rendering the manometer non-functional.
What to do
FDA enforcement status: Ongoing
Brands named
ambu
UPCs
057074801521930570748014951305707480038688057074801522780570748014969805707480149711057074801497350570748014975905707480154395057074801497730570748015235305707480149797
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDAAmbu aScope" 5 Broncho HD 5.6/2.8 Sampler Set. Model Number: 622002000US2025-04-07
- FDAKING LTSD,SIZE 2,W/SUCTION PORT STERILE-Inserted into a patient s pharynx through the mouth to provide patent airway. Model/Catalog Number: KLTSD4222024-09-26
- FDAAMBU / KING LTSD, SIZE 0,1 W/SUCTION PORT, STERILE- Inserted into a patient s pharynx through the mouth to provide patent airway. Model/Catalog Number: KLTSD4202024-09-26
- FDAKING LTSD,SIZE 1,W/SUCTION PORT STERILE-Inserted into a patient s pharynx through the mouth to provide patent airway. Model/Catalog Number: KLTSD4212024-09-26
- FDAKING LTSD,SIZE 2.5, W/SUCTION PORT NON-STERILE KIT-Inserted into a patient s pharynx through the mouth to provide patent airway. Model/Catalog Number: KKLTSD43252024-09-26
- FDAKING LTSD,SIZE 0, W/SUCTION PORT NON-STERILE KIT-Inserted into a patient s pharynx through the mouth to provide patent airway. Model/Catalog Number: KLTSD4302024-09-26
- FDAKING LTSD,SIZE 1, W/SUCTION PORT NON-STERILE KIT-Inserted into a patient s pharynx through the mouth to provide patent airway. Model/Catalog Number: KLTSD4312024-09-26
- FDAKING LTSD,SIZE 2.5, W/SUCTION PORT STERILE-Inserted into a patient s pharynx through the mouth to provide patent airway. Model/Catalog Number: KLTSD42252024-09-26
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