Class II — Mercedes Medical, Inc.
| Recalling firm | MERCEDES MEDICAL LLC |
|---|---|
| Registered facility | MERCEDES MEDICAL LLC (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | No 510(k) clearance |
| 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. |
| Quantity | SAM ENI MTM04 - 58 packs; and SAM ENI MTM04TUBE - 49 packs |
| 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… |
| Initiated | 2021-06-10 |
| Classified | 2021-07-12 |
| Terminated | 2023-08-14 |
| Recall number | Z-2067-2021 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Mercedes Medical, Inc. (Z-2067-2021).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/88088/
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