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Recall Observatory FDA recall evidence

Device evidence

device-recall:cfres:212104

Azurion 5 M20; Catalog numbers: (1) 722228, (2) 722232 (OUS ONLY), (3) 722281 (OUS ONLY).

Official recall number

Z-1156-2025

Evidence summary

Product code
OWB
Recall status
Open, Classified
Event initiated
January 13, 2025
Root cause
Under Investigation by firm
Source snapshot
5482458777762b1480c71ac49b2913b9c7984bb55aac66a4315d018da7cfed2c
Product
Z-1156-2025

Field note

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