Medical Device Recall: Unauthorized Fertility Insemination Kit
All lots of the Ultimate Fertility At Home Insemination Kit sold before December 9, 2019 are recalled. The device was distributed without FDA marketing authorization.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II device distributed without proper marketing authorization represents a risk of harm, as the device's safety and effectiveness were not verified by the FDA. No illnesses or injuries have been reported.
Plain-English summary
Tenderneeds Fertility LLC is recalling the Ultimate Fertility At Home Insemination Kit with Sperm Wash Medium (SKU ULTFKSW). The recall affects all lots sold prior to December 9, 2019. The product was distributed worldwide.
The device was recalled because it was distributed without proper FDA marketing authorization. Devices require FDA approval before they can be marketed and sold to ensure their safety and effectiveness.
The recalled product
- Product
- Ultimate Fertility At Home Insemination Kit with Sperm Wash Medium, SKU ULTFKSW
- Manufacturer
- Tenderneeds Fertility LLC
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- All lots sold prior to December 9
- 2019.
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 9 recalled by Tenderneeds Fertility LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 9 products in this recall →Related recalls
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