Reported Aug 20, 2025 · Ongoing
Ambu SPUR II Labeled as the following: 1 SPUR II Adult Resuscitator, Adult, Catalog Number: 523211000 2 SPUR II Adult…
Ambu Inc.
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Ambu Inc. · 6721 Columbia Gateway Dr Ste 200 · Columbia, MD · 21046-3380
Is this the product you have?
- Ambu SPUR II Labeled as the following1 SPUR II Adult Resuscitator, Adult
- Catalog Number523211000 2 SPUR II Adult Resuscitator w/Mercury Filter, Adult
- Catalog Number523611051 3 SPUR II Adult Resuscitator, Single Patient Use Resuscitator, Adult
- Catalog Number523611057 4 SPUR II Adult Resuscitator, Single Patient Use Resuscitator, Adult
- Catalog Number
524611000 5 SPUR II Adult ResuscitatorPop-off open 40w/PEEP Valve 20Adult
- Catalog Number524611001 6 SPUR II Adult Resuscitator w/PEEP Valve 20, Adult
- Catalog Number524611011 7 SPUR II Adult Resuscitator w/Pressure Limiting Valve, Adult
- Catalog Number524611031 8 SPUR II Adult Resuscitator w/Pressure Limiting Valve, Adult
- Catalog Number524611047 9 SPUR II Adult Resuscitator, Single Patient Use Resuscitator, Adult
- Catalog Number524611051 10 SPUR II Pediatric Resuscitator w/10 O2 tube & Manometer
- Catalog Number530200016 11 SPUR II Pediatric Resuscitator, Single Patient Use Resuscitator, Pediatric
- Catalog Number530212000 12 SPUR II Pediatric Resuscitator, Single Patient Use Resuscitator, Pediatric
- Catalog Number530212001 13 SPUR II Pediatric Resuscitator, Single Patient Use Resuscitator, Pediatric
- Catalog Number530213000 14 SPUR II Pediatric Resuscitator, Single Patient Use Resuscitator, Pediatric
- Catalog Number530213001 15 SPUR II Pediatric Resuscitator, Single Patient Use Resuscitator, Pediatric
- Catalog Number530213011 16 SPUR II Pediatric Resuscitator w/Manometer, Pediatric
- Catalog Number530213030 17 SPUR II Pediatric Resuscitator, Single Patient Use Resuscitator, Pediatric
- Catalog Number530213031 18 SPUR II Pediatric Resuscitator, Single Patient Use Resuscitator, Pediatric
- Catalog Number530213048 19 SPUR II Pediatric Resuscitator, Single Patient Use Resuscitator, Pediatric
- Catalog Number530214000 20 SPUR II Pediatric Resuscitator, Single Patient Use Resuscitator, Pediatric
- Catalog Number530613000 21 SPUR II Pediatric Resuscitator w/Manometer & PEEP Valve 20, Pediatric
- Catalog Number530613031 22 SPUR II Pediatric Resuscitator, Single Patient Use Resuscitator, Pediatric
- Catalog Number530613071 23 SPUR II Pediatric Resuscitator w/PEEP Valve 20,Manometer & CO2 Detector, Pediatric
- Catalog Number530613831 24 SPUR II Pediatric Resuscitator, Single Patient Use Resuscitator, Pediatric
- Catalog Number530614017 25 SPUR II Pediatric Resuscitator w/Manometer, Pediatric
- Catalog Number530614030 26 SPUR II Pediatric Resuscitator w/CO2 Detector, Pediatric
- Catalog Number530614800 27 SPUR II Pediatric Resuscitator, INF& TOD W/Manometer, Pediatric
- Catalog Number530615030 28 SPUR II Pediatric Resuscitator, Single Patient Use Resuscitator, Pediatric
- Catalog Number530619031 29 SPUR II Pediatric Resuscitator w/Expiratory Filter, Manometer PEEP Valve, Pediatric
- Catalog Number531600051 30 SPUR II Pediatric Resuscitator, Single Patient Use Resuscitator, Pediatric
- Catalog Number531613000 31 SPUR II Pediatric Resuscitator, Single Patient Use Resuscitator, Pediatric
- Catalog Number531613001 32 SPUR II Pediatric Resuscitator, Single Patient Use Resuscitator, Pediatric
- Catalog Number531613010 33 SPUR¿ II Pediatric Resuscitator, Single Patient Use Resuscitator, Pediatric
- Catalog Number531613031 34 SPUR II Pediatric Resuscitator, Single Patient Use Resuscitator, Pediatric
- Catalog Number531613047 35 SPUR II Pediatric Resuscitator, Single Patient Use Resuscitator, Pediatric
- Catalog Number531613051 36 SPUR II Pediatric Resuscitator, Single Patient Use Resuscitator, Pediatric
- Catalog Number531614026 37 SPUR II Pediatric Resuscitator, Single Patient Use Resuscitator, Pediatric
- Catalog Number531638000 38 SPUR II Adult Resuscitator, Single Patient Use Resuscitator, Adult
- Catalog Number523611051E 39 SPUR II Pediatric Resuscitator, Single Patient Use Resuscitator, Pediatric
- Catalog Number530213000B The Ambu SPUR II Resuscitator is a single patient use resuscitator intended for pulmonary resus
- Lot codes and dates
39 of 39 products
Products covered by this recall Model / number Barcodes Product as published 52321100005707480152193UDI Number: 05707480152193; Lot Numbers: 1001113554, 1001118764. 52361105105707480149513UDI Number: 05707480149513; Lot Numbers: 2000015874. 52361105705707480038688UDI Number: 05707480038688; Lot Numbers: 2000015876. 52461100005707480152278UDI Number: 05707480152278; Lot Numbers: 1001110297. 52461100105707480149698UDI Number: 05707480149698; Lot Numbers: 2000015881. 52461101105707480149711UDI Number: 05707480149711; Lot Numbers: 2000015882. 52461103105707480149735UDI Number: 05707480149735; Lot Numbers: 2000015884, 2000015968. 52461104705707480149759UDI Number: 05707480149759; Lot Numbers: 2000016102. 52461105105707480154395UDI Number: 05707480154395; Lot Numbers: 2000015969, 2000016252. 53020001605707480149773UDI Number: 05707480149773; Lot Numbers: 2000014933, 2000015857. 53021200005707480152353UDI Number: 05707480152353; Lot Numbers: 1001113557. 53021200105707480149797UDI Number: 05707480149797; Lot Numbers: 2000016408. 53021300005707480152377UDI Number: 05707480152377; Lot Numbers: 1001110299, 1001113558, 1001118767, 1001106634. 53021300105707480152391UDI Number: 05707480152391; Lot Numbers: 1001106635. 53021301105707480152438UDI Number: 05707480152438; Lot Numbers: 1001118768. 53021303005707480149858UDI Number: 05707480149858; Lot Numbers: 2000016409. 53021303105707480152452UDI Number: 05707480152452; Lot Numbers: 1001113560, 1001118769. 53021304805707480154159UDI Number: 05707480154159; Lot Numbers: 2000016529, 2000016410. 53021400005707480152490UDI Number: 05707480152490; Lot Numbers: 1001106636, 1001113561. 53061300005707480152612UDI Number: 05707480152612; Lot Numbers: 1001110301, 1001121455, 1001106637, 1001118771. - Amount recalled
- 87,156 units
Where it was sold
- Nationwide
Why it was recalled
Stop using this product now
Potential for the manometer port being blocked rendering the manometer non-functional.
Using this product could cause serious injury, illness or death — stop using it now.
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