BARD Dynamic XT Steerable, Product Number 201103, REPROCESSED ELECTROPHYSIOLOGY CATHETER
Summary
The FDA issued a Class II for BARD Dynamic XT Steerable, Product Number 201103, REPROCESSED ELECTROPHYSIOLOGY by Stryker Sustainability Solutions. Reason: Incomplete seals on sterile product.
Details
Source
Device Recall
External ID
Z-2179-2026
Action Date
2026-05-20
Status
Ongoing
Category
device
Product Description
BARD Dynamic XT Steerable, Product Number 201103, REPROCESSED ELECTROPHYSIOLOGY CATHETER
Lot/Code Info: UDI 00885825003876, Lot Numbers: xxxxx
Reason for Recall
Incomplete seals on sterile product
Distribution
US Nationwide and the countries of Israel and Canada.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-04-10
Company
Tempe, AZ
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 243 device recalls issued in the same week, part of 413 device-related FDA actions this month.
Stryker Sustainability Solutions has 46 FDA actions in our database, including 35 recalls and 11 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Stryker Sustainability Solutions) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Stryker Sustainability Solutions have FDA actions?
Stryker Sustainability Solutions has 46 FDA actions in our database, including 35 recalls and 11 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2179-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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