Stryker recalls certain Trevo NXT ProVue 3x32 kits that may have high endotoxin levels, increasing risk of fever, shock, or aseptic meningitis. Affected kits include specific catalog numbers and lot codes.
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 Trevo NXT ProVue 3x32 kits that may contain high levels of endotoxins. This could lead to fever, shock, or aseptic meningitis if used improperly.
These kits failed endotoxin testing during manufacturing, potentially containing endotoxins above safe levels. High endotoxin levels can cause fever, shock, or aseptic meningitis in patients.
Medical professionals using these kits for neurovascular procedures are most at risk. Patients receiving these kits during surgery may also be affected.
Check for catalog numbers 90312, 91412-91417, and 914190. Look for specific lot codes listed in the recall notice.
Verify if your kit has catalog numbers 90312, 91412-91417, or 914190.
High endotoxin levels may cause fever, shock, or aseptic meningitis in patients.
Check for catalog numbers 90312, 91412-91417, or 914190 and the specific lot codes listed in the recall notice.
The recall record does not specify a return or remedy action.
We’ve drafted a message you can send Stryker to request your refund or repair — edit it as you like.
Subject: Recall Z-1905-2024 — Stryker Stryker Hello, I own a Stryker that is covered by recall Z-1905-2024 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.
