SurgiSmoke Solutions recalls Flaming: Medium Funnel Model SQ20012-02 due to non-gamma sterilization compatible drape. Affected units sold with UDI-DI 0860012888818 and Lot 8264601.
Certain lots of product were associated with a manufacturing nonconformance involving use of a non-gamma sterilization compatible drape.
SurgiSmoke Solutions is recalling Flamingo Funnel Medium models (SQ20012-02) because they used a drape that isn't safe for gamma sterilization. This could mean the product isn't properly sterilized and might cause infection risks if used in medical settings.
The drape used in these flasks isn't compatible with gamma sterilization, a common method for sterilizing medical equipment. This means the product might not be properly sterilized, increasing infection risks during medical procedures.
Healthcare workers using the Flamingo Funnel Medium in medical procedures are most at risk. Patients receiving care with this specific model could be affected if the drape isn't properly sterilized.
Check for the model number SQ20012-02 on the product. Affected units have UDI-DI 0860012888818 and Lot 8264601.
Look for model number SQ20012-02, UDI-DI 0860012888818, and Lot 8264601 on the product.
The product may not be properly sterilized due to the drape issue, so it's not safe for medical use without a recall fix.
Check for model number SQ20012-02, UDI-DI 0860012888818, and Lot 8264601 on the product.
The recall doesn't specify a remedy, so contact SurgiSmoke Solutions directly for guidance.
We’ve drafted a message you can send SurgiSmoke Solutions to request your refund or repair — edit it as you like.
Subject: Recall Z-1925-2026 — SurgiSmoke Solutions SurgiSmoke Solutions Hello, I own a SurgiSmoke Solutions that is covered by recall Z-1925-2026 from SurgiSmoke Solutions. 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.
