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Recall Observatory FDA recall evidence

Device evidence

device-recall:cfres:213917

Brand Name: Tecfen Medical Product Name: 3.2mm Slit Knife, Angled Model/Catalog Number: QKN3261 Software Version: No software Product Description: This is an ophthalmic knife (manual) that is to be sterile and packaged individually in Tyvek 1059B. Slit knives are used to create precise incisions for controlled entry into the eye. Component: No

Official recall number

Z-1955-2025

Evidence summary

Product code
HNN
Recall status
Open, Classified
Event initiated
April 25, 2025
Root cause
Under Investigation by firm
Source snapshot
5482458777762b1480c71ac49b2913b9c7984bb55aac66a4315d018da7cfed2c
Product
Z-1955-2025

Field note

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