The Recall Desk

Manufacturer

Advance Medical Designs, Inc.

6 recalls in our database name Advance Medical Designs, Inc. as the manufacturing or recalling firm.

What the numbers show

Total
6
Critical
0
Severe
0
Most recent
2023-09-20

Of the 6 recalls from Advance Medical Designs, Inc. we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–6 of 6

  • HighFDA (Devices)·Z-2537-2023·2023-09-20

    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
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2534-2023·2023-09-20

    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
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2535-2023·2023-09-20

    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
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2532-2023·2023-09-20

    ASG-001 ultrasound gel recalled for mislabeling regarding use instructions

    Advance Medical Designs is recalling ASG-001 ultrasound gel due to mislabeling of use instructions. The product was distributed in the US, Canada, UK, Panama, and Netherlands.

    Product
    ASG-001; Ultrasound gel
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2533-2023·2023-09-20

    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
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2536-2023·2023-09-20

    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
    Medical Device
    Distribution
    0 states