Octopus Evolution AS 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 is recalling 288 units of the Octopus Evolution AS Tissue Stabilizer due to an assembly issue with incorrectly positioned tubing.

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, MedicalDevices.

What Happened

Medtronic Perfusion Systems initiated a recall after identifying an assembly issue during manufacturing where the tubing was incorrectly positioned on the Octopus Evolution AS Tissue Stabilizer. The short tube was attached to the bottom of the canister and the long tube to the top, contrary to the intended design.

Which Products Are Affected

The recall affects the Octopus Evolution AS Tissue Stabilizer, Model TS2500. A total of 288 units are involved. Affected products have UDI-DI codes 00643169668904 and 00613994764379, with serial numbers 0232670681, 0232709164, 0232709168, 0232709194, 0232709194, and 0232709199. Distribution was US Nationwide and worldwide.

What You Should Do

Consumers should refer to the recall notice from Medtronic Perfusion Systems for further instructions.

Why This Matters

This Class II recall addresses a manufacturing deviation in a medical device distributed nationwide.

Source

FDA recall Z-2576-2026

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 is recalling 288 units of the Octopus Evolution AS Tissue Stabilizer due to an assembly issue with incorrectly positioned tubing.
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.