Reported Nov 6, 2019 · Terminated

Synchro2, 0.014in x 300cm SOFT Guidewire with Hydrophilic Coating , UPN Product No. M00326310, REF 2631, STERILE:EO -…

Stryker Neurovascular

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Stryker Neurovascular · 47900 Bayside Pkwy · Fremont, CA · 94538-6515

Is this the product you have?

  • Synchro2, 0.014in x 300cm SOFT Guidewire with Hydrophilic Coating , UPN Product No. M00326310, REF 2631
  • STERILEEO -
  • Product Usageproduct is intended for general intravascular use, including neurovascular and peripheral vasculatures
Lot codes and dates

11 of 11 products · 11 lot codes

Recalled lot codes, grouped by product number
Lot NumbersUDI
0000000563
  • (01)04546540688743(17)201031(10)0000000563
0000000986
  • (01)04546540688743(17)201031(10)0000000986
0000001646
  • (01)04546540688743(17)201130(10)0000001646
0000002238
  • (01)04546540688743(17)201130(10)0000002238
0000002426
  • (01)04546540688743(17)201231(10)0000002426
0000002640
  • (01)04546540688743(17)201231(10)0000002640
0000003465
  • (01)04546540688743(17)210131(10)0000003465
0000004906
  • (01)04546540688743(17)210228(10)0000004906
0000005147
  • (01)04546540688743(17)210228(10)0000005147
0000005343
  • (01)04546540688743(17)210228(10)0000005343
Amount recalled
831

This recall covers 8 products

The agency filed one notice per product. You are reading one of them; the other 7 are below.

Where it was sold

Why it was recalled

The notice does not describe the hazard.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Apr 28, 2021 · Data as of Sep 19, 4:50 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.