FDA Device Recall Z-2181-2025
Ambu Inc. · Columbia, MD
Class I — life-threatening Ongoing
Device
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.
Recall record
- Recall number
Z-2181-2025- Classification
- Class I
- Status
- Ongoing
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- Worldwide distribution - US Nationwide and the country of Canada.
- Recall initiated
- 2025-07-09
- Classified by FDA Center
- 2025-08-13
- FDA published
- 2025-08-20
- Recalling firm
- Ambu Inc.
- Firm location
- Columbia, MD
Operational response
A Class I device recall indicates a strong likelihood of serious adverse health consequence or death from continued use. Identify affected units by serial number, lot, or GTIN against your inventory and against implanted-device patient registry. Pull affected inventory from active use immediately. For implanted devices, follow the recalling firm’s patient-notification protocol; in most cases this requires informing affected patients and their treating physicians directly.
For the official FDA enforcement record, see FDA's Recall Search.