Official recall notice

FDA DeviceClass IINotable

FDA Recall: Medtronic GUNDRY Retrograde Cannula Manual-Inflate Silicone Body 13FR, Model 94113T; Cardiopulmo

Recall date
2026-05-27
FDA class
Class II

Why it was recalled

Hazard

Certain lots of product have the potential for a sterile barrier breach.

Recommended action

What to do

3790 units

Product description

Certain lots of product have the potential for a sterile barrier breach.

Verify with the official notice →
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