The Recall Desk

FDA (Devices) recall action 88088

Mercedes Medical, Inc. recalled 2 products on 2021-07-21

The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2021-07-21
Critical
0
Units
—

Why these products were recalled

No 510(k) clearance

The agency’s own wording, quoted from the enforcement report.

States named across these recalls

1–2 of 2

  • ModerateFDA (Devices)··2021-07-21

    Medical device recall: Lingen SAMPLE Virus Sampling Kit lacks FDA clearance

    Mercedes Medical voluntarily recalled Lingen SAMPLE Virus Sampling Kits due to lack of FDA 510(k) clearance. The recall affects units distributed nationwide and internationally.

    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.
    Category
    Distribution
    35 states
  • ModerateFDA (Devices)··2021-07-21

    Medical Device Recall: Lingen Disposable Virus Sampling Kit, No 510(k) Clearance

    The Lingen Disposable Virus Sampling Kit by Mercedes Medical was voluntarily recalled due to lacking FDA 510(k) clearance. The recall affected approximately 11,711 boxes distributed nationwide and internationally.

    Product
    Lingen Disposable Virus Sampling Kit, Item MTM-04, 40 tubes/box.
    Category
    Distribution
    35 states