Stryker recalls Trevo Trak 21 Microcatheter (Catalog 90338) due to potential endotoxin levels exceeding safety standards, which may cause fever, shock, or meningitis. Affected units include specific lots and serial 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 Trevo Trak 21 Microcatheter devices (Catalog 90338) because they may have unsafe endotoxin levels that could cause fever, shock, or meningitis. This recall affects medical devices used in procedures requiring precise catheter placement.
The microcatheter devices may contain higher-than-safe endotoxin levels due to manufacturing process failures. Endotoxins are bacterial components that can trigger fever, shock, or aseptic meningitis if introduced into the body.
Healthcare professionals using the Trevo Trak 21 Microcatheter for medical procedures are most at risk. Patients receiving these devices during surgery or procedures may also be affected.
Check for the catalog number 90338 on the device. Affected units include specific lot numbers: 119461, 119473, 119598, 120070, 120201, 120970, 140512, 136912, 136913, 136914, 136915.
Look for the catalog number 90338 and affected lot numbers on the device.
High endotoxin levels may cause fever, shock, or aseptic meningitis, but the risk is low for most users.
Check for catalog number 90338 and specific lot numbers: 119461, 119473, 119598, 120070, 120201, 120970, 140512, 136912, 136913, 136914, 136915.
The recall does not require immediate discontinuation; check device details to confirm if affected.
We’ve drafted a message you can send Stryker to request your refund or repair — edit it as you like.
Subject: Recall Z-1906-2024 — Stryker Stryker Hello, I own a Stryker that is covered by recall Z-1906-2024 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.
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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.