Stryker recalls certain Synchro guide wires due to potential endotoxin levels exceeding safety standards, which could increase risk of fever, shock, or aseptic meningitis.
Neurovascular devices did not meet the minimum sample size required for endotoxin testing during manufacturing processes and are out of compliance with the AAMI ST72 standard, so these devices may exceed the acceptable limits of endotoxin levels; high levels of endotoxins may increase the risk of fever, shock and aseptic meningitis.
Stryker is recalling specific Synchro guide wires that may have high endotoxin levels. This could lead to fever, shock, or aseptic meningitis if used in medical procedures.
These guide wires may contain excessive endotoxins due to manufacturing process failures. Endotoxins are bacterial components that can cause fever, shock, and aseptic meningitis when introduced into the body.
Healthcare professionals using these guide wires during medical procedures are most at risk. Patients receiving these devices could experience fever, shock, or aseptic meningitis.
Check for the catalog numbers: M00313010 (35 cm tip), M00313310 (300 cm length), M00316310 (200 cm), or M00316330 (300 cm). These wires were sold with specific lot numbers listed in the recall notice.
Identify the catalog number on the product label to determine if it's affected.
High endotoxin levels may increase the risk of fever, shock, or aseptic meningitis.
Check for catalog numbers: M00313010, M00313310, M00316310, or M00316330 with specific lot numbers listed in the recall notice.
The recall does not specify a remedy, so contact Stryker directly for guidance.
We’ve drafted a message you can send Stryker to request your refund or repair — edit it as you like.
Subject: Recall Z-1909-2024 — Stryker Stryker Hello, I own a Stryker that is covered by recall Z-1909-2024 from Stryker. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
