Fresh Recalls

FDAClass II · Medical device · Recall Z-1925-2026 · Recalled April 29, 2026

Flamingo Funnel Medium recall — SurgiSmoke Solutions

Agency report date: April 29, 2026.

1. Compare your item

This notice names a product; your particular item is not yet verified. Compare every applicable model, serial, lot, production-date or model-year boundary below.

Product named
Flamingo Funnel Medium
Company / brand
SurgiSmoke Solutions
Lot / serial / date codes
UDI-DI: 0860012888818; Lot 8264601
Distribution
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.
Agency product description and boundaries

Flamingo Funnel Medium, Model Number SQ20012-02

Still to verify: match the label on your item with the full official notice, including any exclusions, tables and photos. Some identifiers appear only on the agency website and are absent from this data feed. A missing field does not mean all versions are affected.

If your lot or date falls outside a stated range, this notice has not established that your item is affected. This is not a finding about other recalls or product safety.

2. Agency hazard and consumer action

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

No consumer remedy instructions are supplied in this record. Check the official notice and listed company contact for the agency’s current instructions.

Class II: may cause temporary or medically reversible health consequences.

Affected product: Flamingo Funnel Medium recall status

3. Open the official notice or contact

Official recall ID
Z-1925-2026
Brand
All SurgiSmoke Solutions recalls
Classification
Class II
Units affected
2505 units total
Recall status
Ongoing
Initiated
Voluntary: Firm initiated

Affected products

Companies & origin

Recalling firm location
Saint Paul, MN, United States
Firm address
2300 Myrtle Ave Ste 200, N/A, 55114-1948

Identifying details (verbatim from the notice)

Product codes / lots
UDI-DI: 0860012888818; Lot 8264601
Distribution
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.
Firm notified the public via
Letter
FDA event ID
98574
Recall initiated
March 16, 2026
FDA classified
April 22, 2026
FDA report date
April 29, 2026

Other medical device recalls from around the same time

Verify with the official sources:

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Source: U.S. Food & Drug Administration. Agency excerpts come from the public data feed and may omit tables or later changes; the linked government source is authoritative. Source last checked October 22, 2026 at 6:00 PM UTC. Record retrieved July 28, 2026 at 11:00 PM UTC.

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