The Recall Desk

FDA (Devices) recall action 75274

Banyan Medical, LLC recalled 2 products on 2016-10-19

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
2016-10-19
Critical
0
Units
—

Why these products were recalled

Potential lack of assurance of sterility

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

States named across these recalls

1–2 of 2

  • HighFDA (Devices)··2016-10-19

    Banyan Medical Pyramidal Trocar Recalled for Potential Sterility Issues

    Banyan Medical is recalling 5 x 55mm Pyramidal Trocars due to a potential lack of assurance of sterility. The affected units were distributed in Indiana and Tennessee.

    Product
    Banyan Medical 5 x 55mm Regular Pyramidal Trocar and 2x Cannula. For Laproscopic Use- Sterile Single Use Only. Product Code 400-008
    Category
    Distribution
    2 states
  • HighFDA (Devices)··2016-10-19

    Banyan Medical Pyramidal Tip Trocar Recalled for Sterility Concerns

    Banyan Medical is recalling 5 x 55mm Pyramidal Tip Trocars due to a potential lack of assurance of sterility. The recall affects 64 boxes distributed in Indiana and Tennessee.

    Product
    Banyan Medical 5 x 55mm Pyramidal Tip Trocar w/ 2X Cannula w/ Sideport. Laproscopic Use- Sterile Single Use Only Product Code 400-009
    Category
    Distribution
    2 states