Medtronic Octopus Evolution Tissue Stabilizer Recall

Source: FDA · United States

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 134 units of the Octopus Evolution Tissue Stabilizer (Model TS2000) due to incorrect tubing assembly during manufacturing.

What this FDA recall tells you, and what most readers miss

This notice was issued by FDA on August 5, 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-devices.

What Happened

Medtronic Perfusion Systems initiated a voluntary recall after identifying an assembly issue during manufacturing where the short tube was attached to the bottom of the canister and the long tube was attached to the top, contrary to the intended design.

Which Products Are Affected

The recall involves the Octopus Evolution Tissue Stabilizer, Model TS2000. A total of 134 units are affected. The products have UDI-DI 00643169668911 and serial numbers 0232992409, 0233010063, and 0233010115. Distribution was US Nationwide.

What You Should Do

Consumers with affected products should contact Medtronic Perfusion Systems regarding the recall.

Why This Matters

The Class II recall addresses a manufacturing deviation that could affect device performance in surgical settings.

Source

FDA recall number Z-2575-2026

Original source: FDA Official Notice ↗

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.

Frequently Asked Questions

Common questions about this FDA recall.

What is this FDA recall about?
Medtronic Perfusion Systems is recalling 134 units of the Octopus Evolution Tissue Stabilizer (Model TS2000) due to incorrect tubing assembly during manufacturing.
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.