← FDA ENFORCEMENT
Z-2189-2026Class 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
9 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 401603, REPROCESSED ELECTROPHYSIOLOGY CATHETER

Code / lot info

UDI 00885825006969, Lot Numbers: 3978113, 4465650, 4468623, 4594989, 4622932, 4622934, 4629627, 4665006, 4720693.

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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.