Daig Livewire Steerable, Product Number 401603, REPROCESSED ELECTROPHYSIOLOGY CATHETER
FDA Recall Z-2189-2026 · Posted 2026-05-13
Recalling FirmStryker Sustainability Solutions
Recall StatusOpen, Classified
Product CodeNLH
Date Initiated2026-04-10
Product Quantity9 units
Reason for Recall
Incomplete seals on sterile product
Firm 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 [email protected], 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 [email protected] or
Stryker Customer Service at 800-624-4422."
Root Cause
Process control
Distribution Pattern
US Nationwide and the countries of Israel and Canada.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
K100254REPROCESSED CS BI-DIECTIONAL DIAGNOSTIC ELECTROPHYSIOLOGY CATHETERAscent Healthcare Solutions · 2010-05-28K052603REPROCESSED DAIG LIVEWIRE ELECTROPHYSIOLOGY CATHETERSAlliance Medical Corp. · 2005-11-16K030187REPROCESSED ELECTROPHYSIOLOGY CATHETERAlliance Medical, Inc. · 2003-09-24K012708ELECTROPHYSIOLOGY CATHETERAlliance Medical Corp. · 2002-08-13
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.