CLASS II ONGOING Device recall · Reported 29 Apr 2026 · FDA Enforcement Report

Flamingo Funnel Small recalled by SurgiSmoke Solutions

SurgiSmoke Solutions is recalling Flamingo Funnel Small, distributed nationwide in the US. The recall was initiated on 16 Mar 2026 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUDI-DI: 0860012888801; Lot 8264701

Quantity recalled2505 units total

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1924-2026
FDA event ID: 98574
Recalling firm: SurgiSmoke Solutions, Saint Paul, MN
Classification: Class II
Status: Ongoing
Recall initiated: 16 Mar 2026
FDA classified: 22 Apr 2026
Reported: 29 Apr 2026
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Sterility
Device type: Other Medical Devices

Timeline

16 Mar 2026	Recall initiated by company
22 Apr 2026	Classified by FDA	+37 days
29 Apr 2026	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Certain lots of product were associated with a manufacturing nonconformance involving use of a non-gamma sterilization compatible drape.

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

Flamingo Funnel Small, Model Number SQ20012-01

Where it was distributed

Worldwide - US Nationwide distribution in the states of CA, CO, GA, MA, MD, ME, MN, NH, NY, OH, TN, TX, and UT. The country of Canada.

Nationwide California Colorado Georgia Massachusetts Maryland Maine Minnesota New Hampshire New York Ohio Tennessee Texas Utah

Questions about this recall

Why was it recalled?

Certain lots of product were associated with a manufacturing nonconformance involving use of a non-gamma sterilization compatible drape.

Which lots are affected?

UDI-DI: 0860012888801; Lot 8264701

Where was it sold?

Worldwide - US Nationwide distribution in the states of CA, CO, GA, MA, MD, ME, MN, NH, NY, OH, TN, TX, and UT. The country of Canada.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

2 other products · FDA event 98574

Reported	Class	Recall	Company	Reason	Where
29 Apr 2026	CLASS II	Flamingo Funnel Medium recalled by SurgiSmoke Solutions	SurgiSmoke Solutions	Sterility	Nationwide
29 Apr 2026	CLASS II	Flamingo Funnel Large recalled by SurgiSmoke Solutions	SurgiSmoke Solutions	Sterility	Nationwide

Reported	Class	Recall	Company	Reason	Where
29 Apr 2026Device	CLASS II	Flamingo Funnel Large recalled by SurgiSmoke Solutions	SurgiSmoke Solutions	Sterility	Nationwide
29 Apr 2026Device	CLASS II	Flamingo Funnel Medium recalled by SurgiSmoke Solutions	SurgiSmoke Solutions	Sterility	Nationwide

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