Recall Z-2187-2026 ยท NLH Catheter, Recording, Electrode, Reprocessed
Stryker Sustainability Solutions
Daig Livewire Steerable, Product Number 401581; REPROCESSED ELECTROPHYSIOLOGY CATHETER
| Date | May 13, 2026 (initiated Apr 10, 2026) |
| Status | Open, Classified |
| Reason | Incomplete seals on sterile product |
| Root 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 |
| Quantity | 108 units |
| Distribution | US Nationwide and the countries of Israel and Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K012708 | ELECTROPHYSIOLOGY CATHETER Alliance Medical Corp., Aug 13, 2002 |
| K030187 | REPROCESSED ELECTROPHYSIOLOGY CATHETER Alliance Medical, Inc., Sep 24, 2003 |
| K052603 | REPROCESSED DAIG LIVEWIRE ELECTROPHYSIOLOGY CATHETERS Alliance Medical Corp., Nov 16, 2005 |
| K100254 | REPROCESSED CS BI-DIECTIONAL DIAGNOSTIC ELECTROPHYSIOLOGY CATHETER Ascent Healthcare Solutions, May 28, 2010 |