# FDA recall Z-2067-2021

> **Mercedes Medical, Inc.** · Class II · device recall initiated 2021-06-10.

## Product

Lingen SAMPLE Disposable Virus Sampling Kit pack, Item SAM ENI MTM-04, containing 2 tubes and 2 swabs/pack; and SAM ENI MTM04TUBE, containing 1 tube/pack.

## Reason for recall

No 510(k) clearance

## Distribution

Worldwide distribution - US Nationwide distribution including in the states of Alabama, Arizona, California, Colorado, District of Columbia, Florida, Georgia, Iowa, Idaho, Illinois, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Missouri, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Pennsylvania, Texas, Virginia, Washington, Wisconsin, and Puerto Rico. The country of Bahamas.  Government distribution was made but no military distribution.

## Key facts

- **Recall number:** Z-2067-2021
- **Recalling firm:** Mercedes Medical, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-06-10
- **Report date:** 2021-07-21
- **Termination date:** 2023-08-14

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Lakewood Ranch, FL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2067-2021

## Citation

> AI Analytics. FDA recall Z-2067-2021. Retrieved 2026-07-18 from https://api.ai-analytics.org/recall/Z-2067-2021. Source: US FDA. Licensed CC0.

---

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