FDAClass IINovember 27, 2019

Starburst Talon Semi-Flex Electrosurgical Device recall

Starburst Talon Semi-Flex Electrosurgical Device, Part Number H7877001028451 incorrectly labelled as Starburst MRI Semi-Flex Electrosurgical Device…

Why was Starburst Talon Semi-Flex Electrosurgical Device recalled?

The devices are not labelled correctly. End users impacted by this issue may experience a procedural delay.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot 5476032

Product
Starburst Talon Semi-Flex Electrosurgical Device, Part Number H7877001028451 incorrectly labelled as Starburst MRI Semi-Flex Electrosurgical Device…
Recalling firm
Angiodynamics Inc. (Navilyst Medical Inc.)
Quantity
30
Distribution
The products were distributed to the following US states: LA, MA, OR, VA, and WA.
Recall date
November 27, 2019
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls