The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-0232-2020·Announced 2019-11-06

Stryker Neurovascular Recalls Synchro2 Guidewires Due to Labeling Error

Stryker Neurovascular is recalling 305 Synchro2 guidewires because the product labels contain a typographical error in the millimeter dimension.

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, but the source text explicitly identifies the issue as a typographical error in the labeling with no reported injuries or illnesses, fitting the criteria for a moderate severity labeling error.

Plain-English summary

Stryker Neurovascular is recalling 305 units of the Synchro2, 0.014in x 300cm STANDARD PRE-SHAPED Guidewire 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 inches dimension (0.014in) on the label is correct.

The affected product is intended for general intravascular use, including neurovascular and peripheral vasculatures. The recall covers units distributed worldwide, including the United States and numerous international countries. The specific lot numbers and UDI codes for the affected units are listed in the structured product information.

This is a Class II recall. The error is identified as a typographical mistake in the millimeter value. No specific instructions for consumers are provided in the source text, but the recall is limited to the labeling discrepancy.

The recalled product

Product
Synchro2, 0.014in x 300cm STANDARD PRE-SHAPED Guidewire with Hydrophilic Coating, UPN Product No. M00326520, REF 2652, 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
305

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 (5)

  • 0000002645/ (01)04546540688798(17)201231(10)0000002645
  • 0000002771/ (01)04546540688798(17)201231(10)0000002771
  • 0000006204/ (01)04546540688798(17)210331(10)0000006204
  • 0000006875/ (01)04546540688798(17)210401(10)0000006875
  • 0000007429/ (01)04546540688798(17)210430(10)0000007429

Distribution

Distributed nationwide across the United States.

The notice also names 51 states specifically:

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.

See all 8 products in this recall →

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