FDA Medical devices recall ·
Daig Livewire Steerable, Product Number 401582 recall
- Recall number
- Z-2188-2026
- Date
- (initiated April 10, 2026)
- Company / brand
- Stryker Sustainability Solutions
1810 W Drake Dr, Tempe, AZ, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 19 units
- Hazard tags
- Sterility
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Daig Livewire Steerable, Product Number 401582; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Why was it recalled?
Incomplete seals on sterile product
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
UDI 00885825006884, Lot Numbers: 3002664, 4092049, 4580888, 4627994, 4778840, 4860529, 4998452, 4026540, 4098358, 4620256, 4627999, 4813542, 4985859, 4072508, 4498128, 4620257, 4755333, 4860528, 4985861.
Distribution
US Nationwide and the countries of Israel and Canada.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-2188-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.