Stryker Neurovascular: Medical Device Recall in 2019 - (Recall #: Z-0225-2020)

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, 0.014 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.

Product Classification:

Class II

Date Initiated: June 8, 2018

Date Posted: November 6, 2019

Recall Number: Z-0225-2020

Event ID: 81108

Reason for Recall:

The product labels (pouch and carton) for products contain an incorrect value in millimeters (0.036mm) for the Guidewire Outer Diameter dimension. The inches dimension (0.014in) on the label is correct. The correct values are 0.014in (0.36mm). 0.036mm represents a typographical error.

Status: Terminated

Product Quantity: 13503

Code Information:

UPN: M00326010 Lot Numbers/UDI:0000000558 /(01)04546540688729(17)201031(10)0000000558; 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; 0000002639/ (01)04546540688729(17)201231(10)0000002639; 0000002638/ (01)04546540688729(17)201231(10)0000002638; B47912/ (01)04546540688729(17)200930(10)B47912; 0000002764/ (01)04546540688729(17)201231(10)0000002764; 0000002765/ (01)04546540688729(17)201231(10)0000002765; 0000003120/ (01)04546540688729(17)201231(10)0000003120; 0000003463/ (01)04546540688729(17)210131(10)0000003463; 0000003458/ (01)04546540688729(17)210131(10)0000003458; 0000003462/ (01)04546540688729(17)210131(10)0000003462; 0000003593/ (01)04546540688729(17)210109(10)0000003593; 0000003946/ (01)04546540688729(17)210131(10)0000003946; 0000003461/ (01)04546540688729(17)210131(10)0000003461; 0000003460/ (01)04546540688729(17)210131(10)0000003460; 0000003947/ (01)04546540688729(17)210131(10)0000003947; 0000003948/ (01)04546540688729(17)210131(10)0000003948; 0000003679/ (01)04546540688729(17)210111(10)0000003679; 0000004122/ (01)04546540688729(17)210131(10)0000004122; 0000004123/ (01)04546540688729(17)210131(10)0000004123; 0000004356/ (01)04546540688729(17)210131(10)0000004356; 0000004357/ (01)04546540688729(17)210131(10)0000004357; 0000004359/ (01)04546540688729(17)210131(10)0000004359; 0000004360/ (01)04546540688729(17)210131(10)0000004360; 0000004358/ (01)04546540688729(17)210131(10)0000004358; 0000004639/ (01)04546540688729(17)210228(10)0000004639; 0000004642/ (01)04546540688729(17)210228(10)0000004642; 0000004640/ (01)04546540688729(17)210228(10)0000004640; 0000004905/ (01)04546540688729(17)210228(10)0000004905; 0000004998/ (01)04546540688729(17)210214(10)0000004998; 0000005342/ (01)04546540688729(17)210228(10)0000005342; 0000005270/ (01)04546540688729(17)210222(10)0000005270; 0000005534/ (01)04546540688729(17)210331(10)0000005534; 0000005536/ (01)04546540688729(17)210331(10)0000005536; 0000005535/ (01)04546540688729(17)210331(10)0000005535; 0000005537/ (01)04546540688729(17)210331(10)0000005537; 0000005850/ (01)04546540688729(17)210331(10)0000005850; 0000005851/ (01)04546540688729(17)210331(10)0000005851; 0000006312/ (01)04546540688729(17)210331(10)0000006312; 0000006431/ (01)04546540688729(17)210321(10)0000006431; 0000006465/ (01)04546540688729(17)210322(10)0000006465; 0000006477/ (01)04546540688729(17)210331(10)0000006477; 0000006478/ (01)04546540688729(17)210331(10)0000006478; 0000006925/ (01)04546540688729(17)210402(10)0000006925; 0000006616/ (01)04546540688729(17)210331(10)0000006616; 0000006950/ (01)04546540688729(17)210404(10)0000006950; 0000006997/ (01)04546540688729(17)210430(10)0000006997; 0000007313/ (01)04546540688729(17)210430(10)0000007313; 0000007314/ (01)04546540688729(17)210430(10)0000007314; 0000007417/ (01)04546540688729(17)210430(10)0000007417; 0000007422/ (01)04546540688729(17)210430(10)0000007422;

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