FDA Medical Device Recalls (openFDA)
Advance Medical Designs, Inc.: 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) 28-GG521, l) 28-GG521PC, m) 28-GG529, n) 28-GG553, o) 28-GG569, p) 28-GG571, q) 28-GG723
- Recall number
- Z-2537-2023
- Recalling firm
- Advance Medical Designs, Inc.
- 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) 28-GG521, l) 28-GG521PC, m) 28-GG529, n) 28-GG553, o) 28-GG569, p) 28-GG571, q) 28-GG723
- Status
- Open, Classified
- Initiated
- 2023-07-07
- Posted
- 2023-09-09
- Terminated
- not on file
- Reason
- Ultrasound gel mislabeled with inappropriate use.
- Root cause
- Other
- Action
- Advance Medical Designs issued an URGENT MEDICAL DEVICE RECALL notice on 07/27/2023 by email and USPS, first class. The notice explained the problem, hazard, and requested the consignee locate, isolate, and cease all use of the affected products. Distributors were directed to notify their customers. Advance Medical Designs is seeking the return of the affected products.
- Quantity
- 1880 units
- Distribution
- US, Canada, UK, Panama, Netherlands
- Lot, serial or model codes
- a)¿¿¿¿¿ 28-GG023, Lot Numbers: 20794C0208; b)¿¿¿¿ 28-GG105, Lot Numbers: 21123C2346; c)¿¿¿¿¿ 28-GG107, Lot Numbers: 21039C2325; d)¿¿¿¿ 28-GG121, Lot Numbers: 21125C2346; e)¿¿¿¿ 28-GG219, Lot Numbers: 30440C2419; f)¿¿¿¿¿¿ 28-GG223, Lot Numbers: 21120C2341; g)¿¿¿¿¿ 28-GG303, Lot Numbers: 10484C1000; h)¿¿¿¿ 28-GG307, Lot Numbers: 20599C2238; i)¿¿¿¿¿¿ 28-GG519, Lot Numbers: 20599C2238; j)¿¿¿¿¿¿ 28-GG519PC, Lot Numbers: 20709C2256; k)¿¿¿¿¿ 28-GG521, Lot Numbers: 21126C2346; l)¿¿¿¿¿¿ 28-GG521PC, Lot Numbers: 21128C2346; m)¿¿¿ 28-GG529, Lot Numbers: 20783C0208; n)¿¿¿¿ 28-GG553, Lot Numbers: 10486C1000, 20816C2280; o)¿¿¿¿ 28-GG569, Lot Numbers: 21124C2346; p)¿¿¿¿ 28-GG571, Lot Numbers: 30502C2449; q)¿¿¿¿ 28-GG723, Lot Numbers: 30502C2449
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- GDF
- Firm FEI
- 1037885
- Firm city
- Marietta
- Firm state
- GA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28