Z-1358-2021 Class II Ongoing
FDA device recall Z-1358-2021 was initiated by Tenderneeds Fertility LLC on Dec 23, 2020 and is designated Class II. Reason for recall: Device was distributed without a proper marketing authorization. The recall status is ongoing.
Recall Details
- Product Type
- Devices
- Report Date
- Apr 14, 2021
- Initiation Date
- Dec 23, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
Product Description
Deluxe At Home Pro Series Insemination Kit (SKU 644042787958)
Reason for Recall
Device was distributed without a proper marketing authorization.
Distribution Pattern
World-wide distribution.
Code Information
All lots
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1358-2021
- openFDA file date
- Nov 3, 2026
- Loaded by RegDataLab
- Nov 4, 2026