HIGH

CS Uni-Directional w Auto ID, Product Number D135303; REPROCESSED ELECTROPHYSIOLOGY CATHETER

Incomplete seals on sterile product

Quick Facts at a Glance

Recall Date
April 10, 2026
Hazard Level
HIGH
Brand
Stryker Sustainability Solutions
Geographic Scope
1 states

Hazard Information

Incomplete seals on sterile product

What You Should Do

Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Stryker Sustainability Solutions or your healthcare provider for instructions

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Full Description

CS Uni-Directional w Auto ID, Product Number D135303; REPROCESSED ELECTROPHYSIOLOGY CATHETER. Reason: Incomplete seals on sterile product. Classification: Class II. Quantity: 449 units. Distribution: US Nationwide and the countries of Israel and Canada.

View Original Recall on FDA - Medical Devices

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Product Classification

Product Details

Model Numbers
UDI 07613327357301
Lot Numbers: 2934107
3695884
3813841
3963557
+15 more
Affected States
ALL
Report Date
May 20, 2026
Recall Status
ACTIVE

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