FDA Device recall Z-2197-2026
Daig Livewire Steerable, Product Number 401932
- FDA Device
- Class II
- ongoing
- Published 2026-05-20
On 2026-05-20 the FDA classified a Class II recall of Daig Livewire Steerable, Product Number 401932 by Stryker Sustainability Solutions, citing incomplete seals on sterile product.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2197-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-04-10 |
| Published | 2026-05-20 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | Stryker Sustainability Solutions |
| Distribution | US |
Product
Daig Livewire Steerable, Product Number 401932; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Reason
Incomplete seals on sterile product
Identifiers
| code_info | UDI 00885825007355, Lot Numbers: 4248065, 4625922, 4792899, 4880229, 4947722, 4982083, 5004927, 5022043, 5031874, 5063…UDI 00885825007355, Lot Numbers: 4248065, 4625922, 4792899, 4880229, 4947722, 4982083, 5004927, 5022043, 5031874, 5063926, 4253253, 4642049, 4798611, 4880230, 4950352, 4982089, 5004930, 5022044, 5032223, 5063929, 4253255, 4643022, 4804375, 4880231, 4950943, 4982090, 5008468, 5022045, 5032225, 5063931, 4282439, 4650872, 4804411, 4880233, 4950945, 4982091, 5008470, 5022046, 5032226, 5063932, 4369559, 4651469, 4804956, 4880370, 4950946, 4982093, 5008499, 5022051, 5032227, 5063933, 4386017, 4654912, 4808755, 4880374, 4950947, 4982094, 5008537, 5022052, 5033028, 5068012, 4459470, 4666108, 4811587, 4880582, 4950948, 4982095, 5009357, 5022053, 5033804, 5068846, 4464828, 4670429, 4815453, 4880586, 4950949, 4982097, 5012821, 5022055, 5033805, 5070828, 4486895, 4674208, 4816333, 4880587, 4952904, 4983512, 5012842, 5022056, 5034675, 5070908, 4486907, 4674212, 4818581, 4880588, 4952911, 4987173, 5017443, 5022057, 5035406, 5070909, 4487361, 4674869, 4820929, 4880719, 4953421, 4987174, 5019148, 502 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2197-2026%22
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