Codman Galaxy G3 Mini Microcoil Delivery System Recalled for Labeling Error
Codman & Shurtleff Inc is recalling 28 units of the Galaxy G3 Mini Microcoil Delivery System because the label displays the incorrect coil length.
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 and involves a minor labeling error (incorrect coil length) with no reported injuries or illnesses, fitting the criteria for a moderate severity score.
Plain-English summary
Codman & Shurtleff Inc is recalling 28 units of the Galaxy G3 Mini Microcoil Delivery System, Product No. GLM915030 (3 cm). The recall was initiated because the product label contains an incorrect coil length.
The affected units are identified by Lot/Serial No. L14364 and UDI 10886704080138. The distribution pattern for these units is listed as Japan.
This is a Class II recall. The source text does not report any illnesses or injuries associated with this labeling error.
The recalled product
- Product
- GALAXY G3 Mini Microcoil Delivery System Product No: GLM915030 (3 cm).
- Manufacturer
- Codman & Shurtleff Inc
- Hazard
- Affected units
- 28
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/Serial No: L14364 UDI:10886704080138
Distribution
Distribution scope not specified by the agency.
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