FDA Recall of Flamingo Funnel Medium by SurgiSmoke Solutions

Source: FDA · United States and Canada

Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.

SurgiSmoke Solutions is recalling 2505 units of Flamingo Funnel Medium due to a manufacturing nonconformance involving sterilization compatibility.

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

This notice was issued by FDA on May 8, 2026 and geographically references United States and Canada. 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 read it as a data point about the issuing system: how quickly FDA detected the hazard, how precise the geographic or product-identifier scope is, and whether similar notices have clustered in the same category or region in the last 90 days. Cluster patterns frequently precede a broader regulatory action, a single localized FDA recall is isolated; three of them within a quarter often indicate a supply-chain, infrastructure, or seasonal driver that will keep producing notices until something structural changes.

For decision-making, Areazine pairs each alert with the original agency URL, the full agency name, and a timestamp so you can verify the notice against the primary source before acting on it. Tags on this item (recall, product-safety, fda, Devices) map to related alerts in the same area of risk - browsing them together gives a clearer picture than any single notice alone, because the shape of an ongoing issue only becomes visible across multiple sequential alerts.

What Happened

Certain lots of the Flamingo Funnel Medium were recalled due to a manufacturing nonconformance involving the use of a non-gamma sterilization compatible drape.

Which Products Are Affected

The affected product is Flamingo Funnel Medium, Model Number SQ20012-02. A total of 2505 units are involved, with UDI-DI: 0860012888818 and Lot: 8264601. These were distributed in the US states of CA, CO, GA, MA, MD, ME, MN, NH, NY, OH, TN, TX, and UT, as well as in Canada.

What You Should Do

Consumers should follow the initial firm notification via letter and contact SurgiSmoke Solutions for recall instructions.

Why This Matters

This recall highlights potential risks from manufacturing defects in medical devices, emphasizing the importance of proper sterilization to ensure product safety.

Source

Recalled by FDA under recall number Z-1925-2026. For more information, refer to the FDA website.

Original source: FDA Official Notice ↗

All FDA Recalls →

Frequently Asked Questions

Common questions about this FDA recall.

What is this FDA recall about?
SurgiSmoke Solutions is recalling 2505 units of Flamingo Funnel Medium due to a manufacturing nonconformance involving sterilization compatibility.
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 and Canada. 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.