← FDA ENFORCEMENT
Z-2190-2026Class II

Stryker Sustainability Solutions

Recalling firm
Stryker Sustainability Solutions
Product type
Device
Status
Ongoing
Report date
2026-05-20
Distribution
US Nationwide and the countries of Israel and Canada.
Firm state
AZ
Product quantity
24 units
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Environmental Monitoring
Reason for recall

Incomplete seals on sterile product

Product description

Daig Livewire Steerable, Product Number 401652; REPROCESSED ELECTROPHYSIOLOGY CATHETER

Code / lot info

UDI 00885825006983, Lot Numbers: 3430230, 4648604, 4945422, 4999751, 5044134, 5059493, 4454505, 4882788, 4950218, 4999755, 5044135, 5086419, 4454517, 4945388, 4993562, 5044132, 5044136, 5086420, 4648603, 4945405, 4993565, 5044133, 5044137.

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Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.