# FDA recall Z-0130-2022

> **Stradis Medical, LLC dba Stradis Healthcare** · Class II · device recall initiated 2021-09-10.

## Product

Foundation Kit

## Reason for recall

Firm unable to confirm that the tenaculum devices were produced in accordance with required design and manufacturing standards.

## Distribution

Distributed nationwide to VA, SC, CA, PA, MA, FL, TN, NJ, GA, AZ, IL, OH, OK, WA, NY, NV, MO, MD, IN, TX, CO, RI, NC, KY, MT, VI, GA, KS, MI, AK, ID, SD, UT and internationally to Canada.

## Key facts

- **Recall number:** Z-0130-2022
- **Recalling firm:** Stradis Medical, LLC dba Stradis Healthcare
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2021-09-10
- **Report date:** 2021-10-27

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Peachtree Corners, GA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0130-2022

## Citation

> AI Analytics. FDA recall Z-0130-2022. Retrieved 2026-06-03 from https://api.ai-analytics.org/recall/Z-0130-2022. Source: US FDA. Licensed CC0.

---

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