Medtronic DLP Retrograde Cannula Recall Issued
Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.
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 verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, medical-device.
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
Original source: FDA Official Notice ↗
Related FDA Recalls
All FDA Recalls →Nationwide notices with similar length or severity timing 8
Two Areazine-derived peer sets for this FDA recall: nearest notices by body length and by same severity near the same agency date. Peers come from other categories so they are not the same-feed Related list above.
Similar body length
Nearest notices by article body length (1,356 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to June 11, 2026.
Frequently Asked Questions
Common questions about this FDA recall.