Medtronic Bio-Medicus Adult Cannula Kit Recall
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 one lot of its Bio-Medicus Adult Cannula Kit due to loose foreign material containing trace levels of blood.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on August 10, 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, Devices.
What Happened
Medtronic received two complaints of loose foreign material confirmed as containing trace levels of blood in the Medtronic Bio-Medicus Adult Cannula Kit.
Which Products Are Affected
The recall affects the Medtronic Bio-Medicus Adult Cannula Kit, Product Number/CFN 96530-115 (Cardiopulmonary bypass vascular cannula). The affected lot is 230257001 with code MATNR 00763000116019/UDI/DI 00643169769076. Distribution was nationwide in the United States (MD, CA, MI, WA, PA, NC, FL, AR) and worldwide.
What You Should Do
The recall was initiated voluntarily by the firm via letter. Affected units should be handled according to instructions provided by Medtronic Perfusion Systems.
Why This Matters
This Class II recall involves a medical device used in cardiopulmonary bypass procedures distributed across multiple states.
Source
FDA recall number Z-2739-2026, event ID 99199. Medtronic Perfusion Systems, Brooklyn Park, MN.
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 (955 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to August 10, 2026.
Frequently Asked Questions
Common questions about this FDA recall.