Medtronic GUNDRY 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 6,572 units of 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 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 of specific lots of the Medtronic GUNDRY Retrograde Cannula Manual-Inflate Silicone Body 15FR after determining that certain lots have the potential for a sterile barrier breach.
Which Products Are Affected The recall covers the Medtronic GUNDRY Retrograde Cannula, Model 94115T (Cardiopulmonary bypass vascular catheter). Affected units total 6,572 and include GTIN 00643169454521 (Lot Numbers: 0231545565, C231958117) and GTIN 20643169454525 (Lot Numbers: 0231545557, 0231545560, 0231545565, 0231545567, 0231545569, 0231592142, 0231592228, 0231592241, 0231665664, 0231665707, 0231665708, 0231665711, 0231665712, 0231665713, 0231665714, 0231665715, 0231665716, 0231667178, 0231823613, 0231823689, 0231823700, 0231846134, 0231862819, 0231912810, C231958117, C231958118, C231958119, C231958120, C232287623). Distribution was worldwide, including US nationwide.
What You Should Do Consumers and facilities should check inventory for the listed lot numbers and contact Medtronic Perfusion Systems for return or further instructions.
Why This Matters The Class II recall addresses a potential compromise in product sterility for a device used in cardiopulmonary bypass procedures.
Source FDA recall number Z-2215-2026, event ID 98786.
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 (1,325 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.