The Recall Desk

FDA (Devices) recall action 92735

Advance Medical Designs, Inc. recalled 6 products on 2023-09-20

The FDA (Devices) publishes a recall like this one as 6 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 6 pages.

Products
6
Announced
2023-09-20
Critical
0
Units
160,865

Why these products were recalled

Ultrasound gel mislabeled with inappropriate use.

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.

1–6 of 6

  • HighFDA (Devices)··2023-09-20

    Ultrasound gel procedural kits recalled for mislabeled use instructions

    Advance Medical Designs is recalling 1880 ultrasound gel procedural kits due to mislabeling that indicates inappropriate use. The affected kits were distributed in the US, Canada, UK, Panama, and the Netherlands.

    Product
    procedural kits containing ultrasonic transmission gel, Item Numbers: a)¿¿¿¿¿ 28-GG023, b)¿¿¿¿ 28-GG105, c)¿¿¿¿¿ 28-GG107, d)¿¿¿¿ 28-GG121, e)¿¿¿¿ 28-GG219, f)¿¿¿¿¿¿ 28-GG223, g)¿¿¿¿¿ 28-GG303, h)¿¿¿¿ 28-GG307, i)¿¿¿¿¿¿ 28-GG519, j)¿¿¿¿¿¿ 28-GG519PC, k)¿¿¿¿¿
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2023-09-20

    Procedural Kits with Ultrasonic Gel Recalled for Inappropriate Use Labeling

    Advance Medical Designs is recalling 117,875 procedural kits containing ultrasonic transmission gel due to mislabeling of use instructions. The recall affects kits distributed to the United States, Canada, United Kingdom, Panama, and Netherlands.

    Product
    Procedural kits containing ultrasonic transmission gel, Item Numbers: a) 20-PC424, b) 20-PC448, c) 20-PC548, d) 20-PC596, e) 20-PC648
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2023-09-20

    Ultrasound gel recalled for mislabeling with inappropriate use instructions

    Advance Medical Designs is recalling 50-GEL20 ultrasound gel (13,750 units, lot 21043C2328) due to mislabeling with inappropriate use instructions. The product was distributed in the US, Canada, UK, Panama, and the Netherlands.

    Product
    50-GEL20; Ultrasound gel
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2023-09-20

    Procedural kits with ultrasonic transmission gel recalled for mislabeling

    Advance Medical Designs, Inc. is recalling 26,900 procedural kits containing ultrasonic transmission gel due to mislabeling of use instructions. The affected products were distributed in the U.S., Canada, the UK, Panama, and the Netherlands.

    Product
    Procedural kits containing ultrasonic transmission gel, Item Numbers: a) 20-PMT03, b) 20PMT04
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2023-09-20

    Ultrasound Gel Procedural Kits Recalled for Inappropriate Use Mislabeling

    Advance Medical Designs is recalling procedural kits containing ultrasonic transmission gel because the product labeling does not accurately indicate appropriate use. The recall affects 460 units distributed to the US, Canada, UK, Panama, and Netherlands.

    Product
    Procedural kits containing ultrasonic transmission gel, Item Numbers: a) 28-EG103, b) 28-EG125, c) 28-EG135, d) 28-EG151, e) 28-EG161, f) 28-EG163, g) 28-EG197
    Category
    Distribution
    0 states