Procedural kits containing ultrasonic transmission gel — Class II medical device recall Z-2534-2023
Ongoing recall by Advance Medical Designs, Inc., reported 2023-09-20. Ultrasound gel mislabeled with inappropriate use.
| Recall number | Z-2534-2023 |
|---|---|
| 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 | 26,900 units |
| Reason classes | labeling |
| Lot numbers | 30394C3279, 30479C3299 |
Product
Procedural kits containing ultrasonic transmission gel, Item Numbers: a) 20-PMT03, b) 20PMT04
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-2534-2023. 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.