The Recall Desk
Agency classClass IIOur severity:LowFDA (Devices)·Z-0230-2020·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 for the outer diameter.

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 1/5 (Low).

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: The recall is for a minor labeling error (typographical error in millimeter dimension) with no reported injuries or illnesses, fitting the criteria for a Low severity score.

Plain-English summary

Stryker Neurovascular is recalling 6,269 units of Synchro2, 0.014in. x 200cm STANDARD 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. The correct value is 0.36mm, which corresponds to the correct inches dimension of 0.014in. The source text identifies 0.036mm as a typographical error.

The affected products were distributed worldwide, including nationwide in the United States and in numerous international countries. The source text does not report any illnesses or injuries associated with this labeling error.

The recalled product

Product
Synchro2, 0.014in. x 200cm STANDARD PRE-SHAPED Guidewire with Hydrophilic Coating UPN Product No. M00326420, REF 2642, 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
6,269

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)

  • 0000000984/ (01)04546540688774(17)201031(10)0000000984
  • 0000001019/ (01)04546540688774(17)201031(10)0000001019
  • 0000001281/ (01)04546540688774(17)201031(10)0000001281
  • 0000001292/ (01)04546540688774(17)201031(10)0000001292
  • 0000001498/ (01)04546540688774(17)201031(10)0000001498
  • 0000001644/ (01)04546540688774(17)201130(10)0000001644
  • 0000001915/ (01)04546540688774(17)201130(10)0000001915
  • 0000002059/ (01)04546540688774(17)201130(10)0000002059
  • 0000002232/ (01)04546540688774(17)201130(10)0000002232
  • 0000002769/ (01)04546540688774(17)201231(10)0000002769
  • 0000002977/ (01)04546540688774(17)201231(10)0000002977
  • 0000002978/ (01)04546540688774(17)201231(10)0000002978
  • 0000003121/ (01)04546540688774(17)201231(10)0000003121
  • 0000003122/ (01)04546540688774(17)201231(10)0000003122
  • 0000003466/ (01)04546540688774(17)210131(10)0000003466
  • 0000003773/ (01)04546540688774(17)210131(10)0000003773
  • 0000003952/ (01)04546540688774(17)210131(10)0000003952
  • 0000004127/ (01)04546540688774(17)210131(10)0000004127
  • 0000004361/ (01)04546540688774(17)210131(10)0000004361
  • 0000004644/ (01)04546540688774(17)210228(10)0000004644

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 →

Related recalls

Same manufacturer · Stryker Neurovascular

See all →

Same hazard · mis labeling

See all →

Similar recalls