Stryker Neurovascular: Medical Device Recall in 2019 - (Recall #: Z-0227-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

Product Description:

Synchro2, 0.014in x 300cm SOFT Guidewire with Hydrophilic Coating , UPN Product No. M00326310, REF 2631, STERILE:EO - Product Usage: product is intended for general intravascular use, including neurovascular and peripheral vasculatures.

Product Classification:

Class II

Date Initiated: June 8, 2018

Date Posted: November 6, 2019

Recall Number: Z-0227-2020

Event ID: 81108

Reason for Recall:

Status: Terminated

Product Quantity: 831

Code Information:

UPN: M00326310 Lot Numbers/UDI: 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; 0000007637/ (01)04546540688743(17)210421(10)0000007637;

Distribution Pattern:

Worldwide distributions- U.S. Nationwide including the states of AL, AZ, AR, CA, CO, CT, DC, DE, FL, GA, GU, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VT, VA, WA, WV, WI, WY. Countries of Austria, Argentina, Australia, Belgium, Brazil, Bulgaria, Canada, Canary Islands, Chile, China, Colombia, Croatia, Czech Republic, Denmark, Egypt, Finland, France, Germany, Hong Kong, Hungary, India, Indonesia, Iran, Israel, Italy, Japan, Jordan, Lithuania, Mexico, Netherlands, Norway, Philippines, Poland, Portugal, Romania, Russia, Saudi Arabia, Singapore, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, Thailand, Turkey, UAE, and UK.

Voluntary or Mandated:

Voluntary: Firm initiated