FDA Recall of Flamingo Funnel Medium by SurgiSmoke Solutions
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 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
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 ↗
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 (921 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to May 8, 2026.
Frequently Asked Questions
Common questions about this FDA recall.