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Recall Observatory FDA recall evidence

Device product

BARD Dynamic XT Steerable, Product Number 201103, REPROCESSED ELECTROPHYSIOLOGY CATHETER

Z-2179-2026

April 10, 2026

Class II

Product summary

Firm
Stryker Sustainability Solutions
Event
Event 98708
Status
Ongoing
Classification
Class II
Quantity
Unavailable
Official record key
device-enforcement:Z-2179-2026

Official wording

Reason: Incomplete seals on sterile product

Code information: UDI 00885825003876, Lot Numbers: xxxxx

Distribution pattern: US Nationwide and the countries of Israel and Canada.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Incomplete seals on sterile product