Ambu SPUR II (Ambu Inc.) – Manometer Port Blockage (2025)
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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
Brand
Ambu Inc.
Lot Codes / Batch Numbers
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, Lot Numbers: 2000015969, 2000016252. 10. Catalog Number: 530200016, UDI Number: 05707480149773, Lot Numbers: 2000014933, 2000015857. 11. Catalog Number: 530212000, UDI Number: 05707480152353, Lot Numbers: 1001113557. 12. Catalog Number: 530212001, UDI Number: 05707480149797, Lot Numbers: 2000016408. 13. Catalog Number: 530213000, UDI Number: 05707480152377, Lot Numbers: 1001110299, 1001113558, 1001118767, 1001106634. 14. Catalog Number: 530213001, UDI Number: 05707480152391, Lot Numbers: 1001106635. 15. Catalog Number: 530213011, UDI Number: 05707480152438, Lot Numbers: 1001118768. 16. Catalog Number: 530213030, UDI Number: 05707480149858, Lot Numbers: 2000016409. 17. Catalog Number: 530213031, UDI Number: 05707480152452, Lot Numbers: 1001113560, 1001118769. 18. Catalog Number: 530213048, UDI Number: 05707480154159, Lot Numbers: 2000016529, 2000016410. 19. Catalog Number: 530214000, UDI Number: 05707480152490, Lot Numbers: 1001106636, 1001113561. 20. Catalog Number: 530613000, UDI Number: 05707480152612, Lot Numbers: 1001110301, 1001121455, 1001106637, 1001118771. 21. Catalog Number: 530613031, UDI Number: 05707480150212, Lot Numbers: 2000015889. 22. Catalog Number: 530613071, UDI Number: 05707480150298, Lot Numbers: 2000015574. 23. Catalog Number: 530613831, UDI Number: 05707480150373, Lot Numbers: 2000015179, 2000015726, 2000015891. 24. Catalog Number: 530614017, UDI Number: 05707480150397, Lot Numbers: 2000015440. 25. Catalog Number: 530614030, UDI Number: 05707480150410, Lot Numbers: 2000014938, 2000015299. 26. Catalog Number: 530614800, UDI Number: 05707480150434, Lot Numbers: 2000015098. 27. Catalog Number: 530615030, UDI Number: 05707480150472, Lot Numbers: 2000015893. 28. Catalog Number: 530619031, UDI Number: 05707480150595, Lot Numbers: 2000016761. 29. Catalog Number: 531600051, UDI Number: 05707480163441, Lot Numbers: 2000015181, 2000015577. 30. Catalog Number: 531613000, UDI Number: 05707480152773, Lot Numbers: 1001118773, 1001121460, 1001106640. 31. Catalog Number: 531613001, UDI Number: 05707480152797, Lot Numbers: 1001106641, 1001110305, 1001113567, 1001118774. 32. Catalog Number: 531613010, UDI Number: 05707480152810, Lot Numbers: 1001113568. 33. Catalog Number: 531613031, UDI Number: 05707480150717, Lot Numbers: 2000015182, 2000015731, 2000015896, 2000016112, 2000016263. 34. Catalog Number: 531613047, UDI Number: 05707480150755, Lot Numbers: 2000015444, 2000015580, 2000015897, 2000015982. 35. Catalog Number: 531613051, UDI Number: 05707480154470, Lot Numbers: 2000016825. 36. Catalog Number: 531614026, UDI Number: 05707480150854, Lot Numbers: 2000016265, 2000016612. 37. Catalog Number: 531638000, UDI Number: 05707480150878, Lot Numbers: 2000015184, 2000015583. 38. Catalog Number: 523611051E, UDI Number: 05707480154135, Lot Numbers: 2000015292, 2000015559, 2000016401. 39. Catalog Number: 530213000B, UDI Number: 05707480153534, Lot Numbers: 1001113559
Products Sold
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; Lot Numbers: 2000015969, 2000016252. 10. Catalog Number: 530200016; UDI Number: 05707480149773; Lot Numbers: 2000014933, 2000015857. 11. Catalog Number: 530212000; UDI Number: 05707480152353; Lot Numbers: 1001113557. 12. Catalog Number: 530212001; UDI Number: 05707480149797; Lot Numbers: 2000016408. 13. Catalog Number: 530213000; UDI Number: 05707480152377; Lot Numbers: 1001110299, 1001113558, 1001118767, 1001106634. 14. Catalog Number: 530213001; UDI Number: 05707480152391; Lot Numbers: 1001106635. 15. Catalog Number: 530213011; UDI Number: 05707480152438; Lot Numbers: 1001118768. 16. Catalog Number: 530213030; UDI Number: 05707480149858; Lot Numbers: 2000016409. 17. Catalog Number: 530213031; UDI Number: 05707480152452; Lot Numbers: 1001113560, 1001118769. 18. Catalog Number: 530213048; UDI Number: 05707480154159; Lot Numbers: 2000016529, 2000016410. 19. Catalog Number: 530214000; UDI Number: 05707480152490; Lot Numbers: 1001106636, 1001113561. 20. Catalog Number: 530613000; UDI Number: 05707480152612; Lot Numbers: 1001110301, 1001121455, 1001106637, 1001118771. 21. Catalog Number: 530613031; UDI Number: 05707480150212; Lot Numbers: 2000015889. 22. Catalog Number: 530613071; UDI Number: 05707480150298; Lot Numbers: 2000015574. 23. Catalog Number: 530613831; UDI Number: 05707480150373; Lot Numbers: 2000015179, 2000015726, 2000015891. 24. Catalog Number: 530614017; UDI Number: 05707480150397; Lot Numbers: 2000015440. 25. Catalog Number: 530614030; UDI Number: 05707480150410; Lot Numbers: 2000014938, 2000015299. 26. Catalog Number: 530614800; UDI Number: 05707480150434; Lot Numbers: 2000015098. 27. Catalog Number: 530615030; UDI Number: 05707480150472; Lot Numbers: 2000015893. 28. Catalog Number: 530619031; UDI Number: 05707480150595; Lot Numbers: 2000016761. 29. Catalog Number: 531600051; UDI Number: 05707480163441; Lot Numbers: 2000015181, 2000015577. 30. Catalog Number: 531613000; UDI Number: 05707480152773; Lot Numbers: 1001118773, 1001121460, 1001106640. 31. Catalog Number: 531613001; UDI Number: 05707480152797; Lot Numbers: 1001106641, 1001110305, 1001113567, 1001118774. 32. Catalog Number: 531613010; UDI Number: 05707480152810; Lot Numbers: 1001113568. 33. Catalog Number: 531613031; UDI Number: 05707480150717; Lot Numbers: 2000015182, 2000015731, 2000015896, 2000016112, 2000016263. 34. Catalog Number: 531613047; UDI Number: 05707480150755; Lot Numbers: 2000015444, 2000015580, 2000015897, 2000015982. 35. Catalog Number: 531613051; UDI Number: 05707480154470; Lot Numbers: 2000016825. 36. Catalog Number: 531614026; UDI Number: 05707480150854; Lot Numbers: 2000016265, 2000016612. 37. Catalog Number: 531638000; UDI Number: 05707480150878; Lot Numbers: 2000015184, 2000015583. 38. Catalog Number: 523611051E; UDI Number: 05707480154135; Lot Numbers: 2000015292, 2000015559, 2000016401. 39. Catalog Number: 530213000B; UDI Number: 05707480153534; Lot Numbers: 1001113559
Ambu Inc. is recalling Ambu SPUR II Labeled as the following: 1 SPUR II Adult Resuscitator, Adult, Catalog Number: 52321100 due to Potential for the manometer port being blocked rendering the manometer non-functional.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Potential for the manometer port being blocked rendering the manometer non-functional.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026