FDA-Device2019-11-27Class II
Starburst Talon Semi-Flex Electrosurgical Device, Part Number H7877001028451 incorrectly labelled as Starburst MRI Semi-Flex Electrosurgical Device, Part Number H7877001026151
Angiodynamics Inc. (Navilyst Medical Inc.)
Hazard
The devices are not labelled correctly. End users impacted by this issue may experience a procedural delay.
Sold states
The products were distributed to the following US states: LA, MA, OR, VA, and WA.
Affected count
30
Manufactured in
10 Glens Falls Tech Park, N/A, Glens Falls, NY, United States
Products
Starburst Talon Semi-Flex Electrosurgical Device, Part Number H7877001028451 incorrectly labelled as Starburst MRI Semi-Flex Electrosurgical Device, Part Number H7877001026151
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0411-2020Don't want to check this manually?
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