The Recall Desk
Agency classClass IIOur severity:LowFDA (Devices)·Z-0225-2020·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 classified as Low severity because it involves a minor labeling error (typographical error in millimeter dimensions) with no reported injuries or illnesses, fitting the rubric criteria for cosmetic or documentation issues.

Plain-English summary

Stryker Neurovascular is recalling 13,503 units of Synchro2, 0.014 in x 200cm, SOFT Guidewire with Hydrophilic Coating (UPN Product No. M00326010 REF 2601). The recall was initiated because the product labels on the pouch and carton contain an incorrect value in millimeters for the Guidewire Outer Diameter dimension.

The label displays the outer diameter as 0.036mm, which is a typographical error. The correct value is 0.36mm, which corresponds to the correct inches dimension of 0.014in listed on the label. The inches dimension on the label is accurate.

The affected products were distributed worldwide, including nationwide in the United States and in numerous international countries. The source text does not specify instructions for consumers or healthcare providers regarding the disposition of these units.

The recalled product

Product
Synchro2, 0.014 in x 200cm, SOFT Guidewire with Hydrophilic Coating, UPN Product No. M00326010 REF 2601, 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
13,503

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)

  • 0000000560/ (01)04546540688729(17)201031(10)0000000560
  • 0000000671/ (01)04546540688729(17)201031(10)0000000671
  • 0000000672/ (01)04546540688729(17)201031(10)0000000672
  • 0000000980/ (01)04546540688729(17)201031(10)0000000980
  • 0000000987/ (01)04546540688729(17)201031(10)0000000987
  • 0000001013/ (01)04546540688729(17)201031(10)0000001013
  • 0000001014/ (01)04546540688729(17)201031(10)0000001014
  • 0000001275/ (01)04546540688729(17)201031(10)0000001275
  • 0000001274/ (01)04546540688729(17)201031(10)0000001274
  • 0000001276/ (01)04546540688729(17)201031(10)0000001276
  • 0000001287/ (01)04546540688729(17)201031(10)0000001287
  • 0000001285/ (01)04546540688729(17)201031(10)0000001285
  • 0000001492/ (01)04546540688729(17)201031(10)0000001492
  • 0000001286/ (01)04546540688729(17)201031(10)0000001286
  • 0000001493/ (01)04546540688729(17)201031(10)0000001493
  • 0000001909/ (01)04546540688729(17)201130(10)0000001909
  • 0000001910/ (01)04546540688729(17)201130(10)0000001910
  • 0000002053/ (01)04546540688729(17)201130(10)0000002053
  • 0000002054/ (01)04546540688729(17)201130(10)0000002054
  • 0000002425/ (01)04546540688729(17)201231(10)0000002425

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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