Daig Livewire Steerable recall (Stryker Sustainability Solutions)
Medical deviceClass IIOngoing
Summary: Stryker Sustainability Solutions is recalling Daig Livewire Steerable, Product Number 401914; REPROCESSED ELECTROPHYSIOLOGY CATHETER. Reason: Incomplete seals on sterile product.
What is being recalled
Daig Livewire Steerable, Product Number 401914; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Why
Incomplete seals on sterile product
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
US Nationwide and the countries of Israel and Canada.
How to tell if yours is affected
UDI 00885825007294, Lot Numbers: 3293805, 4060170, 4533158, 4613654, 4678077, 4846998, 4973532, 4976226, 5005455, 5056648.
What to do
Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.
Recall facts
| Recall number | Z-2194-2026 |
| Category | Medical device |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | April 10, 2026 |
| Reported | May 20, 2026 |
| Company | Stryker Sustainability Solutions |
| Company location | Tempe, AZ, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 10 units |
More recalls from Stryker Sustainability Solutions · all medical device recalls · recalls from April 2026