FDA Device recall Z-2537-2023
procedural kits containing ultrasonic transmission gel, Item Numbers: a)¿¿¿¿¿ 28-GG023, b)¿¿¿¿ 28-GG105, c)¿¿¿¿¿ 28-GG107, d)¿¿¿¿ 28-GG121,…
- FDA Device
- Class II
- ongoing
- Published 2023-09-20
On 2023-09-20 the FDA classified a Class II recall of procedural kits containing ultrasonic transmission gel, Item Numbers: a)¿¿¿¿¿ 28-GG023, b)¿¿¿¿ 28-GG105, c)¿¿¿¿¿ 28-GG107, d)¿¿¿¿ 28-GG121,… by Advance Medical Designs, citing ultrasound gel mislabeled with inappropriate use.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2537-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-07-07 |
| Published | 2023-09-20 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Advance Medical Designs |
| Distribution | n/a |
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
Reason
Ultrasound gel mislabeled with inappropriate use.
Identifiers
| code_info | a)¿¿¿¿¿ 28-GG023, Lot Numbers: 20794C0208; b)¿¿¿¿ 28-GG105, Lot Numbers: 21123C2346; c)¿¿¿¿¿ 28-GG107, Lot Numbers:…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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2537-2023%22
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