Class 2 Device Recall Daig Livewire Steerable

• Date Initiated by Firm: April 10, 2026
• Date Posted: May 13, 2026
• Recall Status: Open, Classified
• Recall Number: Z-2193-2026
• Recall Event ID: 98708
• 510(K)Number: K012708 K030187 K052603 K100254
• Product Classification: Catheter, recording, electrode, reprocessed - Product Code NLH
• Product: Daig Livewire Steerable, Product Number 401908; REPROCESSED ELECTROPHYSIOLOGY CATHETER
• Code Information: UDI 00885825007287, Lot Numbers: 3459566, 3623281, 4191726.
• FEI Number: 3009350690
• Recalling Firm/ Manufacturer: Stryker Sustainability Solutions; 1810 W Drake Dr; Tempe AZ 85283-4327
• For Additional Information Contact: Ashley Cupples; 707-530-1457
• Manufacturer Reason for Recall: Incomplete seals on sterile product
• FDA Determined Cause: Process control
• Action: 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."
• Quantity in Commerce: 3 units
• Distribution: US Nationwide and the countries of Israel and Canada.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = NLH; 510(K)s with Product Code = NLH; 510(K)s with Product Code = NLH