← FDA ENFORCEMENT
Z-2180-2026Class II

Stryker Sustainability Solutions

What this record is not

A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.

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
5 units
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Environmental Monitoring
Reason for recall

Incomplete seals on sterile product

Product description

BARD Dynamic XT Steerable, Product Number 201104; REPROCESSED ELECTROPHYSIOLOGY CATHETER

Code / lot info

UDI 00885825003890, Lot Numbers: 4064760, 4336810, 4381356, 4381359, 4401919.

Other recalls SPEQ maps to Environmental Monitoring
See all Environmental Monitoring recalls →

Data: U.S. FDA. 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. Open the enforcement explorer →