procedural kits containing ultrasonic transmission gel — Class II medical device recall Z-2537-2023
Ongoing recall by Advance Medical Designs, Inc., reported 2023-09-20. Ultrasound gel mislabeled with inappropriate use.
| Recall number | Z-2537-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Advance Medical Designs, Inc., Marietta, GA, United States |
| Recall initiated | 2023-07-07 |
| Classified | 2023-09-08 |
| Reported by FDA | 2023-09-20 |
| Countries outside the US | CA, GB, NL, PA |
| Quantity | 1,880 units |
| Reason classes | labeling |
| Lot numbers | 10484C1000, 10486C1000, 20599C2238, 20709C2256, 20783C0208, 20794C0208, 20816C2280, 21039C2325, 21120C2341, 21123C2346, 21124C2346, 21125C2346, 21126C2346, 21128C2346, 30440C2419, 30502C2449 |
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 for recall
Ultrasound gel mislabeled with inappropriate use.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2537-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.