Tenderneeds recalls all Pro Series Fertility Devices (SKU 644:4042788139) due to distribution without proper marketing authorization. No specific action steps are provided in the recall notice.
Device was distributed without a proper marketing authorization.
Tenderneeds is recalling all Pro Series Fertility Devices (SKU 644042788139) because they were distributed without proper marketing authorization. This issue does not pose a direct safety risk to users but requires attention to ensure compliance with regulatory standards.
The device was distributed without a proper marketing authorization, which means it may not meet regulatory standards for safety and effectiveness. This issue does not involve physical hazards like fire or injury but relates to regulatory compliance.
All owners of the Pro Series Fertility Device (SKU 644042788139) are affected. Users who have this device should check if it was distributed without proper marketing authorization.
Check for the SKU 644042788139 on the device. All lots of this product are included in the recall.
Look for the SKU 644042788139 on the device to confirm if it is recalled.
The device was distributed without proper marketing authorization, which means it may not meet regulatory standards.
The recall does not specify a need to stop using the device; it focuses on regulatory compliance.
The recall does not provide specific action steps; check the device for the SKU 644042788139 to confirm if it is recalled.
We’ve drafted a message you can send Tenderneeds to request your refund or repair — edit it as you like.
Subject: Recall Z-1363-2021 — Tenderneeds Tenderneeds Hello, I own a Tenderneeds that is covered by recall Z-1363-2021 from Tenderneeds. 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.
