Angiodynamics Recalls Mislabelled Starburst Electrosurgical Devices
Angiodynamics Inc. is recalling 30 Starburst Talon Semi-Flex Electrosurgical Devices that were incorrectly labelled as Starburst MRI Semi-Flex devices, potentially causing procedural delays.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The source text explicitly states that the impact is a 'procedural delay' with no mention of injury, illness, or serious harm, fitting the criteria for a moderate severity recall involving labeling errors without reported adverse health consequences.
Plain-English summary
Angiodynamics Inc. (Navilyst Medical Inc.) is recalling 30 units of the Starburst Talon Semi-Flex Electrosurgical Device, Part Number H7877001028451. These devices were incorrectly labelled as Starburst MRI Semi-Flex Electrosurgical Devices, Part Number H7877001026151.
The recall is due to incorrect labelling. End users impacted by this issue may experience a procedural delay. The affected devices were distributed to the following US states: Louisiana, Massachusetts, Oregon, Virginia, and Washington.
Healthcare providers should stop using the affected devices and contact the manufacturer for further instructions. The recall is classified as Class II by the FDA.
The recalled product
- Product
- Starburst Talon Semi-Flex Electrosurgical Device, Part Number H7877001028451 incorrectly labelled as Starburst MRI Semi-Flex Electrosurgical Device, Part Number H7877001026151
- Manufacturer
- Angiodynamics Inc. (Navilyst Medical Inc.)
- Category
- Medical Device — Electrosurgical
- Hazard
- Affected units
- 30
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot 5476032
Distribution
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