Medtronic DLP Retrograde Cannula Recall Issued

Source: FDA · United States

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Medtronic Perfusion Systems is recalling 260 units of its DLP 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 United States. 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 due to certain lots having the potential for a sterile barrier breach.

Which Products Are Affected

The recall affects Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94965 (cardiopulmonary bypass vascular catheter). Affected units total 260 and are identified by GTIN 20643169454815 and lot numbers 0231665658 and C231786900. Distribution was worldwide, including 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, and Vietnam. The recall number is Z-2222-2026 and it is classified as Class II.

What You Should Do

Healthcare providers and facilities should identify and quarantine affected products according to the firm's instructions.

Why This Matters

The recall involves a medical device used in cardiopulmonary bypass procedures distributed across the United States and numerous international markets.

Source

FDA Recall Z-2222-2026

Original source: FDA Official Notice ↗

All FDA Recalls →

Frequently Asked Questions

Common questions about this FDA recall.

What is this FDA recall about?
Medtronic Perfusion Systems is recalling 260 units of its DLP 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 United States. 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.