The Recall Desk
Agency classClass IIOur severity:LowFDA (Devices)·Z-0231-2020·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 cosmetic labeling defect (typographical error) with no reported injuries or adverse health consequences.

Plain-English summary

Stryker Neurovascular is recalling 2,421 units of Synchro2, 0.014in x 300cm STANDARD Guidewire with Hydrophilic Coating (UPN M00326510, REF 2651). 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. The correct value is 0.36mm, which corresponds to the correct inches dimension of 0.014in listed on the label. 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 countries across Europe, Asia, the Americas, and the Middle East. The source text does not specify instructions for consumers or healthcare providers regarding the disposition of these units.

The recalled product

Product
Synchro2, 0.014in x 300cm STANDARD Guidewire with Hydrophilic Coating UPN Product No. M00326510, REF 2651, STERILE:EO - Product Usage: product is intended for general intravascular use, including neurovascular and peripheral vasculatures.
Manufacturer
Stryker Neurovascular
Category
Medical Device — Interventional Cardiology / Neurovascular
Hazard
Affected units
2,421

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)

  • 0000001020/ (01)04546540688781(17)201031(10)0000001020
  • 0000001499/ (01)04546540688781(17)201031(10)0000001499
  • 0000001916/ (01)04546540688781(17)201130(10)0000001916
  • 0000001645/ (01)04546540688781(17)201130(10)0000001645
  • 0000002060/ (01)04546540688781(17)201130(10)0000002060
  • 0000002061/ (01)04546540688781(17)201130(10)0000002061
  • 0000002979/ (01)04546540688781(17)201231(10)0000002979
  • 0000003123/ (01)04546540688781(17)201231(10)0000003123
  • 0000003771/ (01)04546540688781(17)210131(10)0000003771
  • 0000003772/ (01)04546540688781(17)210131(10)0000003772
  • 0000003953/ (01)04546540688781(17)210131(10)0000003953
  • 0000004128/ (01)04546540688781(17)210131(10)0000004128
  • 0000004362/ (01)04546540688781(17)210131(10)0000004362
  • 0000005992/ (01)04546540688781(17)210331(10)0000005992
  • 0000006203/ (01)04546540688781(17)210331(10)0000006203
  • 0000006318/ (01)04546540688781(17)210331(10)0000006318
  • 0000006483/ (01)04546540688781(17)210331(10)0000006483
  • 0000006621/ (01)04546540688781(17)210331(10)0000006621
  • 0000006828/ (01)04546540688781(17)210401(10)0000006828
  • 0000006622/ (01)04546540688781(17)210331(10)0000006622

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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