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.
What this means for you
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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