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Recall Observatory FDA recall evidence

Device product

BARD Dynamic Tip Steerable, Product Number 200131; REPROCESSED ELECTROPHYSIOLOGY CATHETER

Z-2175-2026

April 10, 2026

Class II

Product summary

Firm
Stryker Sustainability Solutions
Event
Event 98708
Status
Ongoing
Classification
Class II
Quantity
61 units
Official record key
device-enforcement:Z-2175-2026

Official wording

Reason: Incomplete seals on sterile product

Code information: UDI 00885825002930, Lot Numbers: 3966097, 4314254, 4490535, 4511367, 4517632, 4607771, 4762688, 4056491, 4401626, 4490540, 4511368, 4567842, 4628229, 4775309, 4137164, 4455383, 4490542, 4511369, 4567844, 4628232, 4875058, 4154024, 4463033, 4490544, 4511370, 4567866, 4628234, 5023284, 4165178, 4472622, 4495807, 4511372, 4567888, 4628242, 5023285, 4250497, 4490533, 4502016, 4511375, 4567898, 4665767, 5069705, 4300586, 4490534, 4511155, 4514004, 4607745, 4762686.

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