Ambu SPUR II Labeled as the following: 1 SPUR II Adult Resuscitator, Adult, Catalog Number: 523211000 2 SPUR II Adult Re
FDA device recall Z-2181-2025 · posted 2025-08-13 · Open, Classified
Recall details
- Recalling firm
- Ambu Inc.
- Reason for recall
- Potential for the manometer port being blocked rendering the manometer non-functional.
- Action taken
- Ambu notified consignees on about 07/09/2025 via Urgent Field Safety Notice letter. Consignees were instructed to identify if there are any affected units on hand, notify Ambu of how many affected units are in possession, discard those affected units, and complete and return Appendix 1 of the Field Safety Notice. Additionally, consignees were instructed to notify all applicable personnel and notify customers if further distributed.
- Root cause
- Equipment maintenance
- Status
- Open, Classified
- Product code
- BTM
- Quantity affected
- 87,156 units
- Distribution
- Worldwide distribution - US Nationwide and the country of Canada.
- Date initiated
- 2025-07-09
- Date posted
- 2025-08-13
- Location
- Columbia, MD
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Ambu SPUR II Adult Resuscitator, Ambu SPUR II Pediatric Resuscitator, Ambu SPUR II Infant Resuscitator (K152931) | Ambu A/S | 2016-08-29 |