Ambu SPUR II Labeled as the following: 1 SPUR II Adult Resuscitator — Class I medical device recall Z-2181-2025
Ongoing recall by Ambu Inc., reported 2025-08-20, distributed nationwide. Potential for the manometer port being blocked rendering the manometer non-functional.
| Recall number | Z-2181-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ambu Inc., Columbia, MD, United States |
| Recall initiated | 2025-07-09 |
| Classified | 2025-08-13 |
| Reported by FDA | 2025-08-20 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Quantity | 87,156 units |
| UPC / GTIN / UDI-DI | 05707480038688, 05707480149513, 05707480149698, 05707480149711, 05707480149735, 05707480149759, 05707480149773, 05707480149797, 05707480149858, 05707480150212, 05707480150298, 05707480150373, 05707480150397, 05707480150410, 05707480150434, 05707480150472, 05707480150595, 05707480150717, 05707480150755, 05707480150854, 05707480150878, 05707480152193, 05707480152278, 05707480152353, 05707480152377 and 14 more |
| Lot numbers | 1001106634, 1001106635, 1001106636, 1001106637, 1001106640, 1001106641, 1001110297, 1001110299, 1001110301, 1001110305, 1001113554, 1001113557, 1001113558, 1001113559, 1001113560, 1001113561, 1001113567, 1001113568, 1001118764, 1001118767, 1001118768, 1001118769, 1001118771, 1001118773, 1001118774, 1001121455, 1001121460, 2000014933, 2000014938, 2000015098, 2000015179, 2000015181, 2000015182, 2000015184, 2000015292, 2000015299, 2000015440, 2000015444, 2000015559, 2000015574 and 32 more |
| Model numbers | 523211000, 523611051, 523611051E, 523611057, 524611000, 524611001, 524611011, 524611031, 524611047, 524611051, 530200016, 530212000, 530212001, 530213000, 530213000B, 530213001, 530213011, 530213030, 530213031, 530213048, 530214000, 530613000, 530613031, 530613071, 530613831 and 14 more |
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 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
Reason for recall
Potential for the manometer port being blocked rendering the manometer non-functional.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2181-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.