The Recall Desk

FDA (Devices) recall action 85468

Ortho Organizers, Inc. recalled 2 products on 2020-07-08

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
2020-07-08
Critical
0
Units
251

Why these products were recalled

Orthodontic Bracket is mislabeled

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

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–2 of 2

  • ModerateFDA (Devices)··2020-07-08

    Ortho Organizers Recalls Mislabeled Maestro Orthodontic Brackets

    Ortho Organizers is recalling Maestro Orthodontic Brackets due to mislabeling. The recall involves 147 kits distributed to US and international consignees.

    Product
    Maestro Orthodontic Bracket REF711-298Q QTY. 20 Rx Only (01)00190707017064 (10)889437 (422)484 Maestro Orthodontic Bracket REF711-299MCQ QTY. 20 Rx Only (01)00190707017071(10)889437 (422)484
    Category
    Distribution
    6 states
  • ModerateFDA (Devices)··2020-07-08

    Ortho Organizers Recalls Mislabeled Maestro Orthodontic Brackets

    Ortho Organizers is recalling Maestro Orthodontic Brackets due to mislabeling. The recall affects 104 packages distributed to US and international consignees.

    Product
    Maestro Orthodontic Bracket REF711-206-10 QTY. 10 Rx Only (01)00190707016517 (10)112233 (422)484
    Category
    Distribution
    6 states