Stryker recalls FlowGate2 8F catheters (catalogs 90485/90495) due to potential endotoxin levels exceeding safety limits, which may cause fever, shock, or meningitis. Affected units include specific lot numbers.
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 certain FlowGate2 8F neurovascular catheters because they may have unsafe levels of endotoxins from manufacturing. High endotoxin levels could lead to fever, shock, or aseptic meningitis in patients using these devices.
These catheters may contain higher-than-acceptable endotoxin levels due to manufacturing process failures. Endotoxins are bacterial components that can cause fever, shock, or aseptic meningitis if introduced into the bloodstream during medical procedures.
Patients using the recalled FlowGate2 catheters for neurovascular procedures are at risk. Healthcare providers who use these devices for medical treatments may also be affected.
Check for the catalog numbers 90485 (85cm) or 90495 (95cm) on the device. Affected units include specific lot numbers listed in the recall notice.
Identify the catalog number (90485 or 90495) and lot numbers from the recall list to confirm if your device is affected.
High endotoxin levels may cause fever, shock, or aseptic meningitis in patients during medical procedures.
Look for catalog numbers 90485 (85cm) or 90495 (95cm) and specific lot numbers listed in the recall notice.
The recall does not require immediate discontinuation; affected devices should be checked against the provided lot numbers.
We’ve drafted a message you can send Stryker to request your refund or repair — edit it as you like.
Subject: Recall Z-1907-2024 — Stryker Stryker Hello, I own a Stryker that is covered by recall Z-1907-2024 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.
