Ambu SPUR II Labeled as the following: 1 SPUR II Adult… recallZ-2181-2025 · Ambu Inc. · initiated Jul 9, 2025
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Ambu Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Potential for the manometer port being blocked rendering the manometer non-functional.
FDA root cause category: Equipment maintenance
What the company is doing
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.
Recall details
- Recall number
- Z-2181-2025
- Status
- Open, Classified
- Initiated by the company
- Jul 9, 2025
- Posted by the FDA
- Aug 13, 2025
- Recalling firm
- Ambu Inc.
- Quantity
- 87,156 units
- Product code
- BTM
- FDA submissions
- K152931
- Distribution
- Worldwide distribution - US Nationwide and the country of Canada.
Product description
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 Valve, Adult, Catalog Number: 524611031 8 SPUR II Adult Resuscitator w/Pressure Limiting Valve, Adult, Catalog Number: 524611047 9 SPUR II Adult Resuscitator, Single Patient Use Resuscitator, Adult, Catalog Number: 524611051 10 SPUR II Pediatric Resuscitator w/10 O2 tube & Manometer, Catalog Number: 530200016 11 SPUR II Pediatric Resuscitator, Single Patient Use Resuscitator, Pediatric, Catalog Number: 530212000 12 SPUR II Pediatric Resuscitator, Single Patient Use Resuscitator, Pediatric, Catalog Number: 530212001 13 SPUR II Pediatric Resuscitator, Single Patient Use Resuscitator, Pediatric, Catalog Number: 530213000 14 SPUR II Pediatric Resuscitator, Single Patient Use Resuscitator, Pediatric, Catalog Number: 530213001 15 SPUR II Pediatric Resuscitator, Single Patient Use Resuscitator, Pediatric, Catalog Number: 530213011 16 SPUR II Pediatric Resuscitator w/Manometer, Pediatric, Catalog Number: 530213030 17 SPUR II Pediatric Resuscitator, Single Patient Use Resuscitator, Pediatric, Catalog Number: 530213031 18 SPUR II Pediatric Resuscitator, Single Patient Use Resuscitator, Pediatric, Catalog Number: 530213048 19 SPUR II Pediatric Resuscitator, Single Patient Use Resuscitator, Pediatric, Catalog Number: 530214000 20 SPUR II Pediatric Resuscitator, Single Patient Use Resuscitator, Pediatric, Catalog Number: 530613000 21 SPUR II Pediatric Resuscitator w/Manometer & PEEP Valve 20, Pediatric, Catalog Number: 530613031 22 SPUR II Pediatric Resuscitator, Single Patient Use Resuscitator, Pediatric, Catalog Number: 530613071 23 SPUR II Pediatric Resuscitator w/PEEP Valve 20,Manometer & CO2 Detector, Pediatric, Catalog Number: 530613831 24 SPUR II Pediatric Resuscitator, Single Patient Use Resuscitator, Pediatric, Catalog Number: 530614017 25 SPUR II Pediatric Resuscitator w/Manometer, Pediatric, Catalog Number: 530614030 26 SPUR II Pediatric Resuscitator w/CO2 Detector, Pediatric, Catalog Number: 530614800 27 SPUR II Pediatric Resuscitator, INF& TOD W/Manometer, Pediatric, Catalog Number: 530615030 28 SPUR II Pediatric Resuscitator, Single Patient Use Resuscitator, Pediatric, Catalog Number: 530619031 29 SPUR II Pediatric Resuscitator w/Expiratory Filter, Manometer PEEP Valve, Pediatric, Catalog Number: 531600051 30 SPUR II Pediatric Resuscitator, Single Patient Use Resuscitator, Pediatric, Catalog Number: 531613000 31 SPUR II Pediatric Resuscitator, Single Patient Use Resuscitator, Pediatric, Catalog Number: 531613001 32 SPUR II Pediatric Resuscitator, Single Patient Use Resuscitator, Pediatric, Catalog Number: 531613010 33 SPUR II Pediatric Resuscitator, Single Patient Use Resuscitator, Pediatric, Catalog Number: 531613031 34 SPUR II Pediatric Resuscitator, Single Patient Use Resuscitator, Pediatric, Catalog Number: 531613047 35 SPUR II Pediatric Resuscitator, Single Patient Use Resuscitator, Pediatric, Catalog Number:531613051 36 SPUR II Pediatric Resuscitator, Single Patient Use Resuscitator, Pediatric, Catalog Number: 531614026 37 SPUR II Pediatric Resuscitator, Single Patient Use Resuscitator, Pediatric, Catalog Number: 531638000 38 SPUR II Adult Resuscitator, Single Patient Use Resuscitator, Adult, Catalog Number: 523611051E 39 SPUR II Pediatric Resuscitator, Single Patient Use Resuscitator, Pediatric, Catalog Number:530213000B The Ambu SPUR II Resuscitator is a single patient use resuscitator intended for pulmonary resus
Code information (models, lots, serial numbers)
Show the full code information (4k characters)
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
Devices named in this recall
38 devices in the FDA device registry whose identifier appears in the recall's code information.
- Ambu® SPUR® II Pediatric Resuscitator 531600051Ambu A/S · Cardiopulmonary resuscitation aid kit1 recall10 reports
- Ambu® SPUR® II Adult Resuscitator 523611051Ambu A/S · Cardiopulmonary resuscitation aid kit1 recall3 reports
- SPUR® II Adult ResuscitatorSingle Patient Use Resuscitator 523611057Ambu A/S · Ventilator, emergency, manual (resuscitator)1 recall0 reports
- Ambu® SPUR® II Adult Resuscitator 524611001Ambu A/S · Cardiopulmonary resuscitation aid kit1 recall0 reports
- Ambu® SPUR® II Adult Resuscitator 524611011Ambu A/S · Cardiopulmonary resuscitation aid kit1 recall0 reports
- Ambu® SPUR® II Adult Resuscitator 524611031Ambu A/S · Cardiopulmonary resuscitation aid kit1 recall0 reports
- Ambu® SPUR® II Adult Resuscitator 524611047Ambu A/S · Cardiopulmonary resuscitation aid kit1 recall0 reports
- Ambu® SPUR® II Pediatric Resuscitator 530200016Ambu A/S · Cardiopulmonary resuscitation aid kit1 recall0 reports
- Ambu® SPUR® II Pediatric Resuscitator 530212001Ambu A/S · Cardiopulmonary resuscitation aid kit1 recall0 reports
- Ambu® SPUR® II Pediatric Resuscitator 530213030Ambu A/S · Cardiopulmonary resuscitation aid kit1 recall0 reports
- Ambu® SPUR® II Pediatric Resuscitator 530613031Ambu A/S · Cardiopulmonary resuscitation aid kit1 recall0 reports
- Ambu® SPUR® II Pediatric Resuscitator 530613071Ambu A/S · Cardiopulmonary resuscitation aid kit1 recall0 reports
- Ambu® SPUR® II Pediatric Resuscitator 530613831Ambu A/S · Cardiopulmonary resuscitation aid kit1 recall0 reports
- Ambu® SPUR® II Pediatric Resuscitator 530614017Ambu A/S · Cardiopulmonary resuscitation aid kit1 recall0 reports
- Ambu® SPUR® II Pediatric Resuscitator 530614030Ambu A/S · Cardiopulmonary resuscitation aid kit1 recall0 reports
- Ambu® SPUR® II Pediatric Resuscitator 530614800Ambu A/S · Cardiopulmonary resuscitation aid kit1 recall0 reports
- Ambu® SPUR® II Pediatric Resuscitator 530615030Ambu A/S · Cardiopulmonary resuscitation aid kit1 recall0 reports
- Ambu® SPUR® II Pediatric Resuscitator 530619031Ambu A/S · Cardiopulmonary resuscitation aid kit1 recall0 reports
- Ambu® SPUR® II Pediatric Resuscitator 531613031Ambu A/S · Cardiopulmonary resuscitation aid kit1 recall0 reports
- Ambu® SPUR® II Pediatric Resuscitator 531613047Ambu A/S · Cardiopulmonary resuscitation aid kit1 recall0 reports
- Ambu® SPUR® II Pediatric Resuscitator 531614026Ambu A/S · Cardiopulmonary resuscitation aid kit1 recall0 reports
- Ambu® SPUR® II Adult Resuscitator 523211000Ambu A/S · Cardiopulmonary resuscitation aid kit1 recall0 reports
- Ambu® SPUR® II Adult Resuscitator 524611000Ambu A/S · Cardiopulmonary resuscitation aid kit1 recall0 reports
- Ambu® SPUR® II Pediatric Resuscitator 530212000Ambu A/S · Cardiopulmonary resuscitation aid kit1 recall0 reports
- Ambu® SPUR® II Pediatric Resuscitator 530213000Ambu A/S · Cardiopulmonary resuscitation aid kit1 recall0 reports
- Ambu® SPUR® II Pediatric Resuscitator 530213001Ambu A/S · Cardiopulmonary resuscitation aid kit1 recall0 reports
- Ambu® SPUR® II Pediatric Resuscitator 530213011Ambu A/S · Cardiopulmonary resuscitation aid kit1 recall0 reports
- Ambu® SPUR® II Pediatric Resuscitator 530213031Ambu A/S · Cardiopulmonary resuscitation aid kit1 recall0 reports
- Ambu® SPUR® II Pediatric Resuscitator 530214000Ambu A/S · Cardiopulmonary resuscitation aid kit1 recall0 reports
- Ambu® SPUR® II Pediatric Resuscitator 530613000Ambu A/S · Cardiopulmonary resuscitation aid kit1 recall0 reports
- Ambu® SPUR® II Pediatric Resuscitator 531613000Ambu A/S · Cardiopulmonary resuscitation aid kit1 recall0 reports
- Ambu® SPUR® II Pediatric Resuscitator 531613001Ambu A/S · Cardiopulmonary resuscitation aid kit1 recall0 reports
- Ambu® SPUR® II Pediatric Resuscitator 531613010Ambu A/S · Cardiopulmonary resuscitation aid kit1 recall0 reports
- Ambu® SPUR® II Pediatric Resuscitator 530213000BAmbu A/S · Cardiopulmonary resuscitation aid kit1 recall0 reports
- SPUR® Adult Resuscitator 523611051EAmbu A/S · Ventilator, emergency, manual (resuscitator)1 recall0 reports
- SPUR® Pediatric Resuscitator 530213048Ambu A/S · Ventilator, emergency, manual (resuscitator)1 recall0 reports
- SPUR® Adult Resuscitator 524611051Ambu A/S · Ventilator, emergency, manual (resuscitator)1 recall0 reports
- Single Patient Use Resuscitator 531613051Ambu A/S · Ventilator, emergency, manual (resuscitator)1 recall0 reports
Product lines
- Ambu SPUR II Pediatric ResuscitatorAmbu A/S · 26 models · 10 reports · 1 recall
- Ambu SPUR II Adult ResuscitatorAmbu A/S · 11 models · 15 reports · 1 recall
- SPUR Adult ResuscitatorAmbu A/S · 4 models · 3 reports · 1 recall
- SPUR II Adult ResuscitatorSingle Patient Use ResuscitatorAmbu A/S · 3 models · 4 reports · 1 recall
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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