Stryker recalls Daig Livewire Steerable catheters with incomplete sterile seals. These reprocessed electrophysiology catheters may not be sterile, risking infection during procedures.
Incomplete seals on sterile product
Stryker is recalling Daig Livewire Steerable catheters that were reprocessed. Incomplete sterile seals could mean the catheters aren't properly sterile, increasing infection risk during medical procedures.
Incomplete seals on the catheters during reprocessing could allow contamination. This means the catheters might not be sterile when used in medical procedures, potentially causing infections.
Healthcare professionals using the Daig Livewire Steerable catheters for electrophysiology procedures. Patients undergoing these procedures are at risk if the catheters are not sterile.
Check for Product Number 401914, Lot Numbers 3293805, 4060170, 4533158, 4613654, 4678077, 4846998, 4973532, 4976226, or 5005455. The catheters are reprocessed electrophysiology catheters from Stryker.
Identify the Product Number 401914 and Lot Numbers listed in the recall notice.
The catheters have incomplete seals during reprocessing, which could mean they are not sterile when used in medical procedures.
The recall notice does not specify a remedy, so contact Stryker for guidance.
The recall indicates a potential infection risk if the catheters are not sterile during procedures.
We’ve drafted a message you can send Stryker to request your refund or repair — edit it as you like.
Subject: Recall Z-2194-2026 — Stryker Stryker Hello, I own a Stryker that is covered by recall Z-2194-2026 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.
