Mercedes Medical Lingen SAMPLE Virus Sampling Kit Recalled Due to No FDA Clearance
Mercedes Medical recalls Lingen SAMPLE Disposable Virus Sampling Kits with no FDA 510(k) clearance. Affected kits may not be safe for medical use. Consumers should contact the company for details.
Recall notice
No 510(k) clearance
Contact the company
What happened, in plain English
Mercedes Medical is recalling Lingen SAMPLE Disposable Virus Sampling Kits that lack FDA 510(k) clearance. This means the kits may not be safe for medical use, potentially leading to health risks if used improperly. Read more at govinfonow.com/recall/62356-mercedes-medical-lingen-sample-virus-sampling-kit-recalled-due-to.
Source Summary by GovInfoNow · govinfonow.com/recall/62356-mercedes-medical-lingen-sample-virus-sampling-kit-recalled-due-to · Updated August 19, 2026 · FDA enforcement record: FDA #Z-2067-2021
Cite this page
“Mercedes Medical Lingen SAMPLE Virus Sampling Kit Recalled Due to No FDA Clearance.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/62356-mercedes-medical-lingen-sample-virus-sampling-kit-recalled-due-to. Based on FDA recall #Z-2067-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2067-2021%22&limit=1).
Why it’s dangerous
The kits lack FDA 510(k) clearance, meaning they have not been approved for medical use. This could lead to improper testing results or health risks if used without proper safety standards.
Who’s affected
Healthcare workers and individuals using these kits for virus testing may be affected. Those with the specific model numbers and lots are most at risk.
How to tell if you have this one
Check for the model numbers SAM ENI MTM-04 or SAM ENI MTM04TUBE on the packaging. The kits contain 2 tubes and 2 swabs or 1 tube per pack.
- Brand
Mercedes Medical- Category
Medical device
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Terminated- 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.
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| Z-2066-2021 | Lingen Disposable Virus Sampling Kit, Item MTM-04, 40 tubes/box.; All lots. | 6,250 boxes MTM-04 with swab and 5,461 boxes MTM-04 tube only |
| Z-2067-2021 | 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.; All lots. | SAM ENI MTM04 - 58 packs; and SAM ENI MTM04TUBE - 49 packs |
What to do — step by step
Contact Manufacturer
Reach out to Mercedes Medical for specific instructions on how to handle the recalled kits.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 32 states.
FDA 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,…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alabama, Arizona, California, Colorado, District of Columbia, Florida, Georgia, Idaho, Illinois, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, Ohio, Oklahoma, Pennsylvania, Puerto Rico, Texas, Virginia, Washington, Wisconsin.
Recall timeline
FDA terminated this recall 2.2 years after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-2067-2021 (June 10, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2067-2021 to see it in context.
- Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.