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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Critical RiskFDA Device
Medical Devices

Ambu SPUR II Resuscitators Recalled for Non-Functional Manometer Port

Agency Publication Date: August 13, 2025
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Summary

Ambu Inc. has recalled approximately 87,156 Ambu SPUR II Adult and Pediatric Resuscitators because the port for the manometer (the pressure gauge) may be blocked. This manufacturing defect prevents the manometer from functioning, making it impossible for medical providers to monitor the air pressure being delivered to a patient. The recall affects 39 different catalog models distributed worldwide. If you have an affected device, stop using it immediately and contact the manufacturer or your distributor for a replacement.

Risk

A blocked manometer port prevents the resuscitator from accurately measuring and displaying airway pressure during use. This can lead to medical staff delivering too much or too little pressure to a patient's lungs, which can cause lung injury or fail to provide adequate oxygenation, especially in critical care or pediatric patients.

What You Should Do

  1. This recall involves 87,156 Ambu SPUR II Adult and Pediatric Resuscitators across 39 distinct catalog models used for pulmonary resuscitation.
  2. Identify affected products by checking the catalog number, lot number, and Unique Device Identifier (UDI) printed on the device packaging. Affected catalog numbers include 523211000, 523611051, 523611057, 524611000, and 524611001, among others. See the Affected Products section below for the full list of affected codes.
  3. Stop using the recalled devices immediately and remove them from clinical use.
  4. Contact Ambu Inc. or your equipment distributor to arrange for the return, replacement, or correction of the affected units.
  5. Call the FDA Consumer Complaint hotline at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls for more information regarding this recall.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: Ambu SPUR II Adult Resuscitator
Variants: Adult
Model / REF:
523211000
Lot Numbers:
1001113554
1001118764
UDI:
05707480152193
Product: Ambu SPUR II Adult Resuscitator w/Mercury Filter
Variants: Adult, Mercury Filter
Model / REF:
523611051
Lot Numbers:
2000015874
UDI:
05707480149513
Product: Ambu SPUR II Adult Resuscitator, Single Patient Use
Variants: Adult
Model / REF:
523611057
Lot Numbers:
2000015876
UDI:
05707480038688
Product: Ambu SPUR II Adult Resuscitator, Single Patient Use
Variants: Adult
Model / REF:
524611000
Lot Numbers:
1001110297
UDI:
05707480152278
Product: Ambu SPUR II Adult Resuscitator, Pop-off open 40, w/PEEP Valve 20
Variants: Adult, PEEP Valve 20
Model / REF:
524611001
Lot Numbers:
2000015881
UDI:
05707480149698
Product: Ambu SPUR II Adult Resuscitator w/PEEP Valve 20
Variants: Adult, PEEP Valve 20
Model / REF:
524611011
Lot Numbers:
2000015882
UDI:
05707480149711
Product: Ambu SPUR II Adult Resuscitator w/Pressure Limiting Valve
Variants: Adult, Pressure Limiting Valve
Model / REF:
524611031
Lot Numbers:
2000015884
2000015968
UDI:
05707480149735
Product: Ambu SPUR II Adult Resuscitator w/Pressure Limiting Valve
Variants: Adult, Pressure Limiting Valve
Model / REF:
524611047
Lot Numbers:
2000016102
UDI:
05707480149759
Product: Ambu SPUR II Adult Resuscitator, Single Patient Use
Variants: Adult
Model / REF:
524611051
Lot Numbers:
2000015969
2000016252
UDI:
05707480154395
Product: Ambu SPUR II Pediatric Resuscitator w/10' O2 tube & Manometer
Variants: Pediatric, Manometer
Model / REF:
530200016
Lot Numbers:
2000014933
2000015857
UDI:
05707480149773
Product: Ambu SPUR II Pediatric Resuscitator, Single Patient Use
Variants: Pediatric
Model / REF:
530212000
Lot Numbers:
1001113557
UDI:
05707480152353
Product: Ambu SPUR II Pediatric Resuscitator, Single Patient Use
Variants: Pediatric
Model / REF:
530212001
Lot Numbers:
2000016408
UDI:
05707480149797
Product: Ambu SPUR II Pediatric Resuscitator, Single Patient Use
Variants: Pediatric
Model / REF:
530213000
Lot Numbers:
1001110299
1001113558
1001118767
1001106634
UDI:
05707480152377
Product: Ambu SPUR II Pediatric Resuscitator, Single Patient Use
Variants: Pediatric
Model / REF:
530213001
Lot Numbers:
1001106635
UDI:
05707480152391
Product: Ambu SPUR II Pediatric Resuscitator, Single Patient Use
Variants: Pediatric
Model / REF:
530213011
Lot Numbers:
1001118768
UDI:
05707480152438
Product: Ambu SPUR II Pediatric Resuscitator w/Manometer
Variants: Pediatric, Manometer
Model / REF:
530213030
Lot Numbers:
2000016409
UDI:
05707480149858
Product: Ambu SPUR II Pediatric Resuscitator, Single Patient Use
Variants: Pediatric
Model / REF:
530213031
Lot Numbers:
1001113560
1001118769
UDI:
05707480152452
Product: Ambu SPUR II Pediatric Resuscitator, Single Patient Use
Variants: Pediatric
Model / REF:
530213048
Lot Numbers:
2000016529
2000016410
UDI:
05707480154159
Product: Ambu SPUR II Pediatric Resuscitator, Single Patient Use
Variants: Pediatric
Model / REF:
530214000
Lot Numbers:
1001106636
1001113561
UDI:
05707480152490
Product: Ambu SPUR II Pediatric Resuscitator, Single Patient Use
Variants: Pediatric
Model / REF:
530613000
Lot Numbers:
1001110301
1001121455
1001106637
1001118771
UDI:
05707480152612
Product: Ambu SPUR II Pediatric Resuscitator w/Manometer & PEEP Valve 20
Variants: Pediatric, Manometer, PEEP Valve 20
Model / REF:
530613031
Lot Numbers:
2000015889
UDI:
05707480150212
Product: Ambu SPUR II Pediatric Resuscitator, Single Patient Use
Variants: Pediatric
Model / REF:
530613071
Lot Numbers:
2000015574
UDI:
05707480150298
Product: Ambu SPUR II Pediatric Resuscitator w/PEEP Valve 20, Manometer & CO2 Detector
Variants: Pediatric, PEEP Valve 20, Manometer, CO2 Detector
Model / REF:
530613831
Lot Numbers:
2000015179
2000015726
2000015891
UDI:
05707480150373
Product: Ambu SPUR II Pediatric Resuscitator, Single Patient Use
Variants: Pediatric
Model / REF:
530614017
Lot Numbers:
2000015440
UDI:
05707480150397
Product: Ambu SPUR II Pediatric Resuscitator w/Manometer
Variants: Pediatric, Manometer
Model / REF:
530614030
Lot Numbers:
2000014938
2000015299
UDI:
05707480150410
Product: Ambu SPUR II Pediatric Resuscitator w/CO2 Detector
Variants: Pediatric, CO2 Detector
Model / REF:
530614800
Lot Numbers:
2000015098
UDI:
05707480150434
Product: Ambu SPUR II Pediatric Resuscitator, INF& TOD W/Manometer
Variants: Infant/Toddler, Manometer
Model / REF:
530615030
Lot Numbers:
2000015893
UDI:
05707480150472
Product: Ambu SPUR II Pediatric Resuscitator, Single Patient Use
Variants: Pediatric
Model / REF:
530619031
Lot Numbers:
2000016761
UDI:
05707480150595
Product: Ambu SPUR II Pediatric Resuscitator w/Expiratory Filter, Manometer PEEP Valve
Variants: Pediatric, Expiratory Filter, Manometer, PEEP Valve
Model / REF:
531600051
Lot Numbers:
2000015181
2000015577
UDI:
05707480163441
Product: Ambu SPUR II Pediatric Resuscitator, Single Patient Use
Variants: Pediatric
Model / REF:
531613000
Lot Numbers:
1001118773
1001121460
1001106640
UDI:
05707480152773
Product: Ambu SPUR II Pediatric Resuscitator, Single Patient Use
Variants: Pediatric
Model / REF:
531613001
Lot Numbers:
1001106641
1001110305
1001113567
1001118774
UDI:
05707480152797
Product: Ambu SPUR II Pediatric Resuscitator, Single Patient Use
Variants: Pediatric
Model / REF:
531613010
Lot Numbers:
1001113568
UDI:
05707480152810
Product: Ambu SPUR II Pediatric Resuscitator, Single Patient Use
Variants: Pediatric
Model / REF:
531613031
Lot Numbers:
2000015182
2000015731
2000015896
2000016112
2000016263
UDI:
05707480150717
Product: Ambu SPUR II Pediatric Resuscitator, Single Patient Use
Variants: Pediatric
Model / REF:
531613047
Lot Numbers:
2000015444
2000015580
2000015897
2000015982
UDI:
05707480150755
Product: Ambu SPUR II Pediatric Resuscitator, Single Patient Use
Variants: Pediatric
Model / REF:
531613051
Lot Numbers:
2000016825
UDI:
05707480154470
Product: Ambu SPUR II Pediatric Resuscitator, Single Patient Use
Variants: Pediatric
Model / REF:
531614026
Lot Numbers:
2000016265
2000016612
UDI:
05707480150854
Product: Ambu SPUR II Pediatric Resuscitator, Single Patient Use
Variants: Pediatric
Model / REF:
531638000
Lot Numbers:
2000015184
2000015583
UDI:
05707480150878
Product: Ambu SPUR II Adult Resuscitator, Single Patient Use
Variants: Adult
Model / REF:
523611051E
Lot Numbers:
2000015292
2000015559
2000016401
UDI:
05707480154135
Product: Ambu SPUR II Pediatric Resuscitator, Single Patient Use
Variants: Pediatric
Model / REF:
530213000B
Lot Numbers:
1001113559
UDI:
05707480153534

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 97166
Status: Active
Manufacturer: Ambu Inc.
Sold By: medical supply distributors; hospitals; emergency medical services
Manufactured In: United States
Units Affected: 87,156 units
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.