No image published for this recall

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Ambu® spur®ii adult and pediatric resuscitator

Official notice

23 Jul 2025

Last checked

23 Jul 2025

Critical riskHealth Canada

An official Health Canada notice concerns Ambu® spur®ii adult and pediatric resuscitator. A total of five complaints have been reported for the SPUR II device regarding a blocked manometer port, rendering the attached manometer non-functional. No patient involvement has been reported. In the affected devices, pressure monitoring is not possible via the manometer port or the attached manometer. While the SPUR II's ability to deliver oxygen remains intact, this defect increases the risk of barotrauma if the pressure-limiting valve is overridden. It may also lead to procedural delays and temporary hypoxia due to user uncertainty when operating a device without a functional manometer. Recall start date: July 14, 2025 Published 2025-07-23.

What to do now

Discard the affected products and contact the manufacturer for a refund or replacement.

Recall number

77746

Official notice

2025-07-23

The hazard

A total of five complaints have been reported for the SPUR II device regarding a blocked manometer port, rendering the attached manometer non-functional. No patient involvement has been reported. In the affected devices, pressure monitoring is not possible via the manometer port or the attached manometer. While the SPUR II's ability to deliver oxygen remains intact, this defect increases the risk of barotrauma if the pressure-limiting valve is overridden. It may also lead to procedural delays and temporary hypoxia due to user uncertainty when operating a device without a functional manometer. Recall start date: July 14, 2025

How to check if you're affected

Compare the product name and identifiers below with the item you own. Follow the official notice if they match.

Recall Numbers

77746

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Affected products

Product 1

Affected products - Ambu® SPUR®II Adult Resuscitator, Lot or serial number - 1001113554, Model or catalog number - 523211000

Product 2

Affected products - Ambu® SPUR®II Adult Resuscitator, Lot or serial number - 1001118764, Model or catalog number - 523211000

Product 3

Affected products - Ambu® SPUR®II Adult Resuscitator, Lot or serial number - 1001110297, Model or catalog number - 524611000

Product 4

Affected products - Ambu® SPUR®II Pediatric Resuscitator, Lot or serial number - 1001110299, Model or catalog number - 530213000

Product 5

Affected products - Ambu® SPUR®II Pediatric Resuscitator, Lot or serial number - 1001106636, Model or catalog number - 530214000

Product 6

Affected products - Ambu® SPUR®II Pediatric Resuscitator, Lot or serial number - 1001113558, Model or catalog number - 530213000

Product 7

Affected products - Ambu® SPUR®II Pediatric Resuscitator, Lot or serial number - 1001106635, Model or catalog number - 530213001

Product 8

Affected products - Ambu® SPUR®II Pediatric Resuscitator, Lot or serial number - 1001106637, Model or catalog number - 530613000

Product 9

Affected products - Ambu® SPUR®II Pediatric Resuscitator, Lot or serial number - 1001118767, Model or catalog number - 530213000

Product 10

Affected products - Ambu® SPUR®II Pediatric Resuscitator, Lot or serial number - 2000015889, Model or catalog number - 530613031

Product 11

Affected products - Ambu® SPUR®II Pediatric Resuscitator, Lot or serial number - 1001113560, Model or catalog number - 530213031

Product 12

Affected products - Ambu® SPUR®II Pediatric Resuscitator, Lot or serial number - 1001106634, Model or catalog number - 530213000

Product 13

Affected products - Ambu® SPUR®II Pediatric Resuscitator, Lot or serial number - 1001118769, Model or catalog number - 530213031

Risk / hazard

A total of five complaints have been reported for the SPUR II device regarding a blocked manometer port, rendering the attached manometer non-functional. No patient involvement has been reported. In the affected devices, pressure monitoring is not possible via the manometer port or the attached manometer. While the SPUR II's ability to deliver oxygen remains intact, this defect increases the risk of barotrauma if the pressure-limiting valve is overridden. It may also lead to procedural delays and temporary hypoxia due to user uncertainty when operating a device without a functional manometer. Recall start date: July 14, 2025

Where it was sold

The source does not list specific retailers. See the official notice for where affected products were sold.

Location 1

CA · Canada

Affected area 1

CA · Canada

Company & contacts

Manufacturer

Not provided

Phone

Not provided

Brand: Ambu A S, Ambu® Spur®ii Adult And Pediatric Resuscitator.

Source & status

Source

Health Canada

Tier

official

Category

HEALTH

Classification

Type II

App estimate

critical

Recall details

Recall number

77746

Classification

Type II

Source tier

official

Documents, notices & source

See the official notice and source documents for full details.

View full official notice
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