Ambu Inc.

Devices and FDA recall records listed on MedWatcher for Ambu Inc..

What MedWatcher tracks

This page covers the devices and recall records listed below, not the complete product catalogue or recall history. A recall may apply only to specific models, lots, or serial numbers.

Tracked devices: 0
Recall records: 1
Source records last checked: Oct 27, 2026

Manufacturer names

Device and manufacturer names are linked using official product, UDI, or FDA records. The source links below show the supporting information.

Official records may use a legal name, brand, division, or shortened name. Similar names do not necessarily refer to the same manufacturer.

Ambu Inc.Source-name variantOfficial source (opens in a new tab)

Sources used for this page

U.S. Food and Drug AdministrationFDA medical device recall event 97166Last checked Aug 16, 2026

Recent recall records

Class I recallOngoing

Ambu SPUR II Labeled as the following: 1 SPUR II Adult Resuscitator, recall — FDA event 97166

Potential for the manometer port being blocked rendering the manometer non-functional.

FDA · FDA event 97166Posted Aug 13, 2025

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Ambu Inc.

Devices and FDA recall records listed on MedWatcher for Ambu Inc..

What MedWatcher tracks

This page covers the devices and recall records listed below, not the complete product catalogue or recall history. A recall may apply only to specific models, lots, or serial numbers.

Tracked devices: 0
Recall records: 1
Source records last checked: Oct 27, 2026

Manufacturer names

Device and manufacturer names are linked using official product, UDI, or FDA records. The source links below show the supporting information.

Official records may use a legal name, brand, division, or shortened name. Similar names do not necessarily refer to the same manufacturer.

Ambu Inc.Source-name variantOfficial source (opens in a new tab)

Sources used for this page

U.S. Food and Drug AdministrationFDA medical device recall event 97166Last checked Aug 16, 2026

Recent recall records

Class I recallOngoing

Ambu SPUR II Labeled as the following: 1 SPUR II Adult Resuscitator, recall — FDA event 97166

Potential for the manometer port being blocked rendering the manometer non-functional.

FDA · FDA event 97166Posted Aug 13, 2025

Ambu Inc.

Follow Ambu Inc.

What MedWatcher tracks

Manufacturer names

Sources used for this page

Recent recall records

Ambu SPUR II Labeled as the following: 1 SPUR II Adult Resuscitator, recall — FDA event 97166

Ambu Inc.

Follow Ambu Inc.

What MedWatcher tracks

Manufacturer names

Sources used for this page

Recent recall records

Ambu SPUR II Labeled as the following: 1 SPUR II Adult Resuscitator, recall — FDA event 97166