Class I — Ambu Inc.
| Recalling firm | Ambu A/S |
|---|---|
| Registered facility | AMBU INNOVATION GMBH (the firm's only registered facility) |
| Classification | Class I |
| Status | Ongoing |
| Reason | Potential for the manometer port being blocked rendering the manometer non-functional. |
| 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 SPUR II Adult Resuscitator, Single Patient Use Resuscitator, Adult, Catalog Number: 524611000 5 SPUR II Adult Resuscitator, Pop-off open 40 ,w/PEEP Valve 20, Adult, Catalog Number: 524611001 6 SPUR II Adult Resuscitator w/PEEP Valve 20, Adult, Catalog Number: 524611011 7 SPUR II Adult Resuscitator w/Pressure Limiting V… |
| Quantity | 87,156 units |
| Distribution | Worldwide distribution - US Nationwide and the country of Canada. |
| Initiated | 2025-07-09 |
| Classified | 2025-08-13 |
| Recall number | Z-2181-2025 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class I recall — Ambu Inc. (Z-2181-2025).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/97166/
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