REF: 126590 — Class II medical device recall Z-0777-2024
Ongoing recall by Turkuaz Saglik Hizmetleri Medikal Temizlik Kim. Ur. San. ve Tic. A.S., reported 2024-01-31, distributed in IL. Sterility of Ultrasound gel can not be guaranteed.
| Recall number | Z-0777-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Turkuaz Saglik Hizmetleri Medikal Temizlik Kim. Ur. San. ve Tic. A.S., Esenyurt, N/A, Turkey |
| Recall initiated | 2023-06-09 |
| Classified | 2024-01-20 |
| Reported by FDA | 2024-01-31 |
| Distributed | IL |
| Countries outside the US | HK |
| Quantity | 4,923,471 |
| Reason classes | sterility |
| Lot numbers | SJ01041120, SJ03061021, SJ06022023, SJ09091021, SJ10091019, SJ11021021, SJ14071021, SJ20091021, SJ20111020, SJ22111019, SJ24061021, SJ25061020, SJ25081020 |
| Model numbers | 126590 |
Product
REF: 126590, MEDLINE, STERILE ULTRASOUND GEL, 0.70 FL oz. (20 mL), QTY: 50, STERILER, CE 2292
Reason for recall
Sterility of Ultrasound gel can not be guaranteed.
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-0777-2024. 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.