Stryker Sustainability Solutions recalls Daig Livewire Steerable

Incomplete seals on sterile product

Daig Livewire Steerable, Product Number 401914; REPROCESSED ELECTROPHYSIOLOGY CATHETER

Stryker issued a Medical Device Recall notice to its consignees on 4/10/2026 via USPS certified mail. The notice explained the product issue, potential risk, and requested the following: "Customer Actions Requested: Our records indicate that you may have distributed, received and/or used the above affected products. 1. Inform individuals within your organization who need to be aware of this action. 2. Check your internal inventory to locate the affected product. Segregate the affected products, quarantine and discontinue use. 3. Please complete the Business Reply Form and return the completed via email to SSSPFA@stryker.com, or use the QR Code on Attachment B. Response is required. a. If you have indicated that product remains in your inventory, a prepaid shipping label will be issued for the return of the product. Credit will be issued to your facility for products returned upon receipt. 4. Maintain awareness of this communication internally until all required actions have been completed within your facility." "For any additional information or questions please reach out to SSSPFA@stryker.com or Stryker Customer Service at 800-624-4422."

• FDA enforcement recordOfficial FDA database entry for Z-2194-2026
• FDA 510(k) clearance · K012708The device's official FDA premarket clearance record
• FDA 510(k) clearance · K030187The device's official FDA premarket clearance record
• FDA 510(k) clearance · K052603The device's official FDA premarket clearance record
• FDA 510(k) clearance · K100254The device's official FDA premarket clearance record
• FDA device classification · NLHOfficial FDA classification for this device type
• CFR regulation · 21 CFR 870.1220The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Stryker Sustainability SolutionsSearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.