Medical DeviceAug 20, 2025
Ambu SPUR II Labeled as the following: 1 SPUR II Adult Resuscitator, Adult recall — FDA Z-2181-2025
Potential for the manometer port being blocked rendering the manometer non-functional.
Class IFDA: OngoingAmbu Inc.
Recall history in this database
Classification mix: Class II: 1, Class I: 1.
Medical DeviceMay 14, 2025
Ambu aScope" 5 Broncho HD 5.6/2.8 Sampler Set recall — FDA Z-1723-2025
Incorrect labeling in which the front red pouch label did not match the actual size of the medical device. The label on the front of the scope incorrectly states 5.0/2.2 while the back…
Class IIFDA: OngoingAmbu Inc.
Understanding this recall history
This page summarizes recall records in which the official source identifies Ambu Inc. as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.