SurgiSmoke recalls Flaming: Flamingo Funnel Large (Model SQ20012-03) due to non-gamma sterilization compatible drape. Affected units sold with UDI-DI 408882777851966 and Lot 8264501.
Certain lots of product were associated with a manufacturing nonconformance involving use of a non-gamma sterilization compatible drape.
SurgiSmoke is recalling Flamingo Funnel Large models (SQ20012-03) because they used a drape that isn't safe for gamma sterilization. This could lead to unsafe use in medical settings where sterilization is critical.
The drape used in these flasks isn't compatible with gamma sterilization, a common method for medical devices. This means the device might not be properly sterilized, increasing infection risks during medical procedures.
Healthcare facilities using the Flamingo Funnel Large model with UDI-DI 408882777851966 and Lot 8264501 are most at risk. Patients and staff in these settings may be affected if the drape isn't properly sterilized.
Check for the model number SQ20012-03 on the Flamingo Funnel Large. Affected units have UDI-DI 408882777851966 and Lot 8264501.
Look for model number SQ20012-03, UDI-DI 408882777851966, and Lot 8264501 on the device.
The product uses a drape that isn't safe for gamma sterilization, which could lead to improper sterilization in medical settings.
The recall record doesn't specify a remedy, so contact SurgiSmoke Solutions for guidance.
The hazard involves potential infection risks from improper sterilization, but no specific injury mechanism is described.
We’ve drafted a message you can send SurgiSmoke to request your refund or repair — edit it as you like.
Subject: Recall Z-1926-2026 — SurgiSmoke SurgiSmoke Hello, I own a SurgiSmoke that is covered by recall Z-1926-2026 from SurgiSmoke. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
