Medtronic DLP Retrograde Cannula Recall Due to Sterile Barrier Breach
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Medtronic is recalling certain lots of its DLP Retrograde Cannula after identifying a potential sterile barrier breach affecting 2,620 units distributed worldwide.
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, Devices.
What Happened
Medtronic Perfusion Systems initiated a voluntary recall of specific lots of the Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR due to the potential for a sterile barrier breach.
Which Products Are Affected
The recall covers the Medtronic DLP Retrograde Cannula, Cardiopulmonary bypass vascular catheter, Model 94725. Affected units total 2,620 and include:
- GTIN 00643169454736, Lot Numbers: 0231650787, 0231758255, 0231862812, C231966207
- GTIN 00673978188713, Lot Numbers: 0231937422
- GTIN 20643169454730, Lot Numbers: 0231650787, 0231650793, 0231758250, 0231758255, 0231758279, 0231758282, 0231823523, 0231862812, 0231937422, C231965721, C231966207, C232428221, C232430086
The products were distributed nationwide in the United States and to 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, Uruguay, and Vietnam. This is FDA Recall Number Z-2218-2026, classified as Class II.
What You Should Do
Consumers and healthcare facilities should check inventory for the listed lot numbers and contact Medtronic Perfusion Systems for return or replacement instructions.
Why This Matters
A sterile barrier breach in a cardiopulmonary bypass vascular catheter could compromise product sterility during surgical procedures.
Source
FDA Enforcement Report, Recall Number Z-2218-2026
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 (1,653 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.