Procedural kits containing ultrasonic transmission gel — Class II medical device recall Z-2535-2023
Ongoing recall by Advance Medical Designs, Inc., reported 2023-09-20. Ultrasound gel mislabeled with inappropriate use.
| Recall number | Z-2535-2023 |
|---|---|
| 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 | 117,875 units |
| Reason classes | labeling |
| Lot numbers | 20145C2088, 20163C2097, 20622C2244, 21088C2341, 21109C2345, 30353C3268, 30371C3276, 30481C3301 |
Product
Procedural kits containing ultrasonic transmission gel, Item Numbers: a) 20-PC424, b) 20-PC448, c) 20-PC548, d) 20-PC596, e) 20-PC648
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-2535-2023. 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.