Class I FDA device recall · Z-2181-2025

Class I — the FDA judged there is a reasonable probability that use of the product would cause serious harm or death.

This is the FDA's risk judgment for this recall. It describes the potential of the product as a category — it does not establish that any specific unit harmed anyone.

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

Why it was recalled

Potential for the manometer port being blocked rendering the manometer non-functional.

Is your unit affected?

The recall covers only the specific lots or serial numbers the FDA listed. Enter the lot or serial number from your product's label and we'll check it against that list.

A match means your unit may be covered — stop and call your pharmacist before doing anything. No match suggests it isn't covered, but confirm anyway: code formats vary and lists can be incomplete. Your unit not being listed does not guarantee it is safe, and being listed does not mean you have been harmed.

Show the FDA's listed lot / code information

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

Recall status

Ongoing — the recall is still being carried out.

Where it was distributed

Worldwide distribution - US Nationwide and the country of Canada.

Recall record

Recalling firm: Ambu Inc.
Product type: Devices
Recall number: Z-2181-2025
Voluntary / mandated: Voluntary: Firm initiated
Initial notification: Letter
Origin: Columbia, MD
Recall initiated: 2025-07-09

What to do

Check the lot/code above against your product. To confirm this record and read the FDA's full notice, see the FDA recall page. Before changing anything you take or use, ask your pharmacist or prescriber — this page does not tell you to start or stop any drug or device.

Also available: structured data (JSON-LD) · recall record (JSON)

What this is — and is not

A recall is a recorded FDA enforcement action — the FDA logged that a firm is removing or correcting a product. It does not establish that any specific unit harmed anyone, and causation is not established by a recall. The class above is the FDA's risk judgment for the product category, not a finding about your unit. This page informs and compares; it is not medical advice and never tells you to start or stop a drug or device.

To report a problem you experienced, use FDA MedWatch. Verify this record at FDA recalls · Recall Z-2181-2025 · Source: openFDA enforcement.