The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-0226-2020·Announced 2019-11-06

Stryker Neurovascular Recalls Synchro2 Guidewires Due to Labeling Error

Stryker Neurovascular is recalling 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 and involves a minor labeling error (typographical error in dimensions) with no reported injuries or illnesses, fitting the Moderate severity criteria.

Plain-English summary

Stryker Neurovascular is recalling 3,720 units of Synchro2, 0.014in x 200cm, SOFT PRE-SHAPED Guidewires with Hydrophilic Coating. The recall is due to a labeling error on the product pouch and carton. The labels display an incorrect value of 0.036mm for the Guidewire Outer Diameter dimension, whereas the correct value is 0.36mm. The inch dimension (0.014in) on the label is correct.

The affected products were distributed worldwide, including nationwide in the United States and in numerous international countries. The source text identifies this as a Class II recall. The incorrect millimeter value is described as a typographical error.

The recalled product

Product
Synchro2, 0.014in x 200cm, SOFT PRE-SHAPED Guidewire with Hydrophilic Coating, UPN Product No. M00326110, REF 2611, STERILE: EO - Product Usage: product is intended for general intravascular use, including neurovascular and peripheral vasculatures.
Manufacturer
Stryker Neurovascular
Category
Medical Device — Guidewires
Hazard
Affected units
3,720

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 (20)

  • 0000001015/ (01)04546540688736(17)201031(10)0000001015
  • 0000001277/ (01)04546540688736(17)201031(10)0000001277
  • 0000001288/ (01)04546540688736(17)201031(10)0000001288
  • 0000001494/ (01)04546540688736(17)201031(10)0000001494
  • 0000000981/ (01)04546540688736(17)201031(10)0000000981
  • 0000002055/ (01)04546540688736(17)201130(10)0000002055
  • 0000002239/ (01)04546540688736(17)201130(10)0000002239
  • 0000002973/ (01)04546540688736(17)201231(10)0000002973
  • 0000003130/ (01)04546540688736(17)201231(10)0000003130
  • 0000003131/ (01)04546540688736(17)201231(10)0000003131
  • 0000003464/ (01)04546540688736(17)210131(10)0000003464
  • 0000003949/ (01)04546540688736(17)210131(10)0000003949
  • 0000003680/ (01)04546540688736(17)200112(10)0000003680
  • 0000004124/ (01)04546540688736(17)210131(10)0000004124
  • 0000005456/ (01)04546540688736(17)200227(10)0000005456
  • 0000005986/ (01)04546540688736(17)210331(10)0000005986
  • 0000006197/ (01)04546540688736(17)210331(10)0000006197
  • 0000006198/ (01)04546540688736(17)210331(10)0000006198
  • 0000006313/ (01)04546540688736(17)210331(10)0000006313
  • 0000006479/ (01)04546540688736(17)210331(10)0000006479

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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