Medtronic GUNDRY Retrograde Cannula Recall for Sterile Barrier Breach

Source: FDA · Worldwide

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Medtronic is recalling 3,790 units of its GUNDRY Retrograde Cannula due to potential sterile barrier breach in certain lots.

What this FDA recall tells you, and what most readers miss

This notice was issued by FDA on June 11, 2026 and geographically references Worldwide. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.

Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to read it as a data point about the issuing system: how quickly FDA detected the hazard, how precise the geographic or product-identifier scope is, and whether similar notices have clustered in the same category or region in the last 90 days. Cluster patterns frequently precede a broader regulatory action, a single localized FDA recall is isolated; three of them within a quarter often indicate a supply-chain, infrastructure, or seasonal driver that will keep producing notices until something structural changes.

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What Happened

Medtronic Perfusion Systems initiated a voluntary recall of specific lots of the Medtronic GUNDRY Retrograde Cannula because certain lots have the potential for a sterile barrier breach.

Which Products Are Affected

The recall affects the Medtronic GUNDRY Retrograde Cannula Manual-Inflate Silicone Body 13FR, Model 94113T (Cardiopulmonary bypass vascular catheter). A total of 3,790 units are involved. Affected GTINs and lot numbers include GTIN 00673978188447 (Lot 0231651336) and GTIN 20643169454877 (Lots: 0231651336, 0231651345, 0231651385, 0231651389, 0231651396, 0231667029, 0231667046, 0231757975, 0231758248, 0231758259, 0231936467, 0231982226, 0232274424, C232287618, C232287619, C232287620, C232598550, C232598552). The recall covers worldwide distribution including the United States and numerous other countries.

What You Should Do

Consumers and healthcare facilities should check inventory for the listed lots and follow instructions provided in the firm's notification letter for returns or further guidance. Contact Medtronic Perfusion Systems for additional information.

Why This Matters

The recall involves a Class II medical device distributed globally, addressing a potential compromise in product sterility.

Source

FDA recall number Z-2214-2026 (event ID 98786).

Original source: FDA Official Notice ↗

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Frequently Asked Questions

Common questions about this FDA recall.

What is this FDA recall about?
Medtronic is recalling 3,790 units of its GUNDRY Retrograde Cannula due to potential sterile barrier breach in certain lots.
Which agency issued this alert?
This alert was issued by FDA. The original notice is available at the source link at the bottom of this article.
How severe is this alert?
This alert is classified as "medium" severity. Stay informed and follow agency guidance.
What area is affected?
This alert affects Worldwide. Check with FDA for the most current geographic scope.
Where can I find more FDA Recalls updates?
Browse the full FDA Recalls feed on Areazine at areazine.com/recalls/fda/ for the latest updates from FDA and other agencies.