# FDA recall Z-2176-2021

> **Tenderneeds Fertility LLC** · Class II · device recall initiated 2020-12-23.

## Product

Home Artificial Insemination Kit Human IUI ICI Pregnancy & Ovulation Tests, SKU midiuikt

## 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

Worldwide distribution.

## Key facts

- **Recall number:** Z-2176-2021
- **Recalling firm:** Tenderneeds Fertility LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2020-12-23
- **Report date:** 2021-08-11

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Greenville, IN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2176-2021

## Citation

> AI Analytics. FDA recall Z-2176-2021. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-2176-2021. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*