CLASS II Device recall · Reported 21 Jul 2021 · FDA Enforcement Report

Lingen Disposable Virus Sampling Kit recalled by Mercedes Medical

Mercedes Medical is recalling Lingen Disposable Virus Sampling Kit, distributed nationwide in the US. The recall was initiated on 10 Jun 2021 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesAll lots.

Quantity recalled6,250 boxes MTM-04 with swab and 5,461 boxes MTM-04 tube only

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2066-2021
FDA event ID: 88088
Recalling firm: Mercedes Medical, Lakewood Ranch, FL
Classification: Class II
Status: Terminated
Recall initiated: 10 Jun 2021
FDA classified: 12 Jul 2021
Reported: 21 Jul 2021
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

10 Jun 2021	Recall initiated by company
12 Jul 2021	Classified by FDA	+32 days
21 Jul 2021	Published in enforcement report	+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

No 510(k) clearance

Product as listed by the FDA

Lingen Disposable Virus Sampling Kit, Item MTM-04, 40 tubes/box.

Where it was distributed

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.

Nationwide Alabama Arizona California Colorado District of Columbia Florida Georgia Iowa Idaho Illinois Kansas Kentucky Louisiana Massachusetts Maryland Maine Michigan Missouri Montana North Carolina

Questions about this recall

Is Lingen Disposable Virus Sampling Kit recalled?

Yes. Mercedes Medical recalled Lingen Disposable Virus Sampling Kit on 10 Jun 2021. The recall is Class II and its status is Terminated. Recall number Z-2066-2021.

Why was it recalled?

No 510(k) clearance

Which lots are affected?

All lots.

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Mercedes Medical

All 2

Reported	Class	Recall	Company	Reason	Where
21 Jul 2021Device	CLASS II	Lingen Sample Disposable Virus Sampling Kit pack recalled	Mercedes Medical	Other	Nationwide

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