Z-2198-2026 Class II Ongoing
FDA device recall Z-2198-2026 was initiated by Stryker Sustainability Solutions on April 10, 2026 and is designated Class II. Reason for recall: Incomplete seals on sterile product The recall status is ongoing. Affected quantity: 2 units.
Recall Details
- Product Type
- Devices
- Report Date
- May 20, 2026
- Initiation Date
- April 10, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2 units
Product Description
Daig Livewire Steerable BDB, Product Number 401918, REPROCESSED ELECTROPHYSIOLOGY CATHETER
Reason for Recall
Incomplete seals on sterile product
Distribution Pattern
US Nationwide and the countries of Israel and Canada.
Code Information
UDI 00885825007324, Lot Numbers: 4101996, 4175347.