SurgiSmoke Solutions recalls Flaming: Small model SQ20012-01 due to non-gamma sterilization compatible drape. Affected units sold with UDI-DI 0860012888801, Lot 8264701.
Certain lots of product were associated with a manufacturing nonconformance involving use of a non-gamma sterilization compatible drape.
SurgiSmoke Solutions is recalling their Flamingo Funnel Small (model SQ20012-01) because some units used a drape that isn't safe for gamma sterilization. This could lead to improper sterilization of medical equipment, risking infections during surgery.
The drape used in certain lots isn't compatible with gamma sterilization. This means the medical equipment might not be properly sterilized, increasing infection risks during surgical procedures.
Healthcare professionals using the Flamingo Funnel Small in surgical settings are most at risk. Patients undergoing surgery with improperly sterilized equipment could face infection risks.
Check for the model number SQ20012-01 on the product. Affected units have UDI-DI 0860012888801 and Lot 8264701.
Look for model number SQ20012-01, UDI-DI 0860012888801, and Lot 8264701 on the product.
The recall indicates some units have a drape that isn't safe for gamma sterilization, so affected units should not be used for surgical purposes.
Check for model number SQ20012-01, UDI-DI 0860012888801, and Lot 8264701 on the product.
The recall doesn't specify a remedy, so contact SurgiSmoke Solutions for guidance on safe handling.
We’ve drafted a message you can send SurgiSmoke Solutions to request your refund or repair — edit it as you like.
Subject: Recall Z-1924-2026 — SurgiSmoke Solutions SurgiSmoke Solutions Hello, I own a SurgiSmoke Solutions that is covered by recall Z-1924-2026 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.
