Manual resuscitators recalled because blocked manometer port may disable pressure gauge
Ambu is recalling 87,156 SPUR II adult resuscitators because the manometer port may be blocked, leaving the manometer non-functional. The FDA classified the action as Class I.
What this means for you
Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The rubric assigns 5 to any FDA Class I recall, and the FDA classified this resuscitator action as Class I.
Plain-English summary
Ambu SPUR II adult resuscitators are being recalled across a range of catalog numbers, including 523211000, 523611051, 523611057, 524611000, 524611001, 524611011, 524611031 and 524611047, covering the standard adult resuscitator and versions supplied with a mercury filter, a PEEP valve or a pressure limiting valve. Affected lot numbers are listed against each catalog number in the recall notice. The recall covers 87,156 units distributed in the United States and Canada.
The recall was issued because of the potential for the manometer port to be blocked, which renders the manometer non-functional. The manometer is the gauge that shows the pressure being delivered during manual ventilation. The FDA classified the action as Class I, its most serious category.
Hospitals, ambulance services and other users should check their stock against the catalog and lot numbers in the recall notice, remove affected units from service, and follow Ambu's instructions for replacement.
The recalled product
- Product
- 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
- Manufacturer
- Ambu Inc.
- Category
- Medical Device — Resuscitation
- Hazard
- blocked-port
- manometer-failure
- resuscitator
- class-i
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 1. Catalog Number: 523211000
- UDI Number: 05707480152193
- Lot Numbers: 1001113554
- 1001118764. 2. Catalog Number: 523611051
- UDI Number: 05707480149513
- Lot Numbers: 2000015874. 3. Catalog Number: 523611057
- UDI Number: 05707480038688
- Lot Numbers: 2000015876. 4. Catalog Number: 524611000
- UDI Number: 05707480152278
- Lot Numbers: 1001110297. 5. Catalog Number: 524611001
- UDI Number: 05707480149698
- Lot Numbers: 2000015881. 6. Catalog Number: 524611011
- UDI Number: 05707480149711
- Lot Numbers: 2000015882. 7. Catalog Number: 524611031
- UDI Number: 05707480149735
- Lot Numbers: 2000015884
- 2000015968. 8. Catalog Number: 524611047
- UDI Number: 05707480149759
- Lot Numbers: 2000016102. 9. Catalog Number: 524611051
- UDI Number: 05707480154395
Distribution
Distributed nationwide across the United States.
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