Z-2214-2026 Class II Ongoing
FDA device recall Z-2214-2026 was initiated by Medtronic Perfusion Systems on April 21, 2026 and is designated Class II. Reason for recall: Certain lots of product have the potential for a sterile barrier breach. The recall status is ongoing. Affected quantity: 3790 units.
Recall Details
- Product Type
- Devices
- Report Date
- May 27, 2026
- Initiation Date
- April 21, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3790 units
Product Description
Medtronic GUNDRY Retrograde Cannula Manual-Inflate Silicone Body 13FR, Model 94113T; Cardiopulmonary bypass vascular catheter
Reason for Recall
Certain lots of product have the potential for a sterile barrier breach.
Distribution Pattern
Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium, Canada, China, Colombia, Costa Rica, Cyprus, Denmark, France, Germany, Hong Kong, Hungary, Italy, Japan, Latvia, Lithuania, Malaysia, Moldova, Republic Of, Morocco, Netherlands, Norway, Panama, Poland, Russia, Serbia, Singapore, South Africa, South Korea, Spain, Suriname, Sweden, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, United States, Uruguay, Vietnam.
Code Information
GTIN 00673978188447, Lot Numbers: 0231651336; GTIN 20643169454877, Lot Numbers: 0231651336, 0231651345, 0231651385, 0231651389, 0231651396, 0231667029, 0231667046, 0231757975, 0231758248, 0231758259, 0231936467, 0231982226, 0232274424, C232287618, C232287619, C232287620, C232598550, C232598552.