Home / Recalls / Tenderneeds Fertility LLC / Z-2180-2021

Z-2180-2021 Class II Ongoing

Recalled by Tenderneeds Fertility LLC — Greenville, IN

FDA device recall Z-2180-2021 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. This event is an expansion of RES 87581, Z-1355-2021 thru Z-1364-2021. The recall status is ongoing.

Recall Details

Product Type: Devices
Report Date: Aug 11, 2021
Initiation Date: Dec 23, 2020
Voluntary/Mandated: Voluntary: Firm initiated

Product Description

TenderNeeds Fertility PRO IUI Human Artificial Home Insemination Kits, SKU 133166055771

Reason for Recall

Device was distributed without a proper marketing authorization. This event is an expansion of RES 87581, Z-1355-2021 thru Z-1364-2021.

Distribution Pattern

Worldwide distribution.

Code Information

All lots sold prior to December 9, 2019.

Source

Dataset: openFDA device recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for Z-2180-2021
openFDA file date: Nov 3, 2026
Loaded by RegDataLab: Nov 4, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.

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