Mercedes Medical, Inc.: Medical Device Recall in 2021 - (Recall #: Z-2067-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: June 10, 2021

Date Posted: July 21, 2021

Recall Number: Z-2067-2021

Event ID: 88088

Reason for Recall:

No 510(k) clearance

Status: Terminated

Product Quantity: SAM ENI MTM04 - 58 packs; and SAM ENI MTM04TUBE - 49 packs

Code Information:

All lots.

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated