Stryker Neurovascular Recalls Synchro2 Guidewires Due to Labeling Error
Stryker Neurovascular is recalling 107 Synchro2 guidewires because the product labels contain a typographical error in the millimeter dimension for the outer diameter.
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 and involves a minor labeling error (typographical error in dimensions) without reported injuries or illnesses, fitting the criteria for a moderate severity score.
Plain-English summary
Stryker Neurovascular is recalling 107 units of Synchro2, 0.014in. x 300cm, SOFT PRE-SHAPED Guidewires with Hydrophilic Coating. The recall is due to a labeling error on the product pouch and carton. The labels incorrectly list the Guidewire Outer Diameter as 0.036mm, whereas the correct value is 0.36mm. The inch dimension (0.014in) on the label is correct, and the 0.036mm value is identified as a typographical error.
The affected products are intended for general intravascular use, including neurovascular and peripheral vasculatures. The recall covers units distributed worldwide, including nationwide in the United States and in numerous international countries. The specific lot numbers affected are 0000001911 and 0000002062.
Healthcare providers and consumers should check their inventory for these specific lot numbers and stop using the affected guidewires. The recall is classified as Class II by the FDA, indicating a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Synchro2, 0.014in. x 300cm, SOFT PRE-SHAPED Guidewire with Hydrophilic Coating, UPN Product No. M00326320, REF 2632, STERILE:EO - Product Usage: product is intended for general intravascular use, including neurovascular and peripheral vasculatures.
- Manufacturer
- Stryker Neurovascular
- Category
- Medical Device — Guidewire
- Hazard
- Affected units
- 107
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)
- 0000002062/ (01)04546540688750(17)201130(10)0000002062.
Distribution
Part of a larger recall action
This product is one of 8 recalled by Stryker Neurovascular under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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