← FDA ENFORCEMENT
Z-2176-2026Class 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
28 units
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Environmental Monitoring
Reason for recall

Incomplete seals on sterile product

Product description

BARD Dynamic Tip Steerable, Product Number 200344; REPROCESSED ELECTROPHYSIOLOGY CATHETER

Code / lot info

UDI 00885825003135, Lot Numbers: 2268964, 2687510, 3173767, 3269330, 3379246, 4398753, 4876242, 2501717, 2878890, 3231930, 3336473, 3394078, 4780878, 4876243, 2533915, 3137651, 3266358, 3361335, 3454810, 4821709.

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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.