FDA Medical Device Recalls (openFDA)
Turkuaz Saglik Hizmetleri Medikal Temizlik Kim. Ur. San. ve Tic. A.S.: REF: 126590, MEDLINE, STERILE ULTRASOUND GEL, 0.70 FL oz. (20 mL), QTY: 50, STERILER, CE 2292
- Recall number
- Z-0777-2024
- Recalling firm
- Turkuaz Saglik Hizmetleri Medikal Temizlik Kim. Ur. San. ve Tic. A.S.
- Product
- REF: 126590, MEDLINE, STERILE ULTRASOUND GEL, 0.70 FL oz. (20 mL), QTY: 50, STERILER, CE 2292
- Status
- Open, Classified
- Initiated
- 2023-06-09
- Posted
- 2024-01-20
- Terminated
- not on file
- Reason
- Sterility of Ultrasound gel can not be guaranteed.
- Root cause
- Nonconforming Material/Component
- Action
- On June 5, 2023, Turkuaz issued a "Field Safety Notice to affected consignee(s). On December 13, 2023, an updated notification was provided to affected consignee(s) Turkuaz asked consignees to return the recalled items or destroy them. If you have any questions, email the Quality Director at secil.pala@turkuazsaglik.com.tr .
- Quantity
- 4,923,471
- Distribution
- US distribution to: Illinois and OUS (foreign) distribution to: Hong Kong
- Lot, serial or model codes
- Lot Nos. SJ10091019 SJ22111019 SJ01041120 SJ25081020 SJ25061020 SJ20111020 SJ11021021 SJ24061021 SJ03061021 SJ14071021 SJ20091021 SJ09091021 SJ06022023 SJ10091019
- 510(k) numbers
- ["K130581"]
- PMA numbers
- not on file
- Product code
- MUI
- Firm FEI
- 3009482034
- Firm city
- Esenyurt
- Firm state
- not on file
- Firm country
- Turkey
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28