Z-0777-2024Class II

REF: 126590, MEDLINE, STERILE ULTRASOUND GEL, 0.70 FL oz. (20 mL), QTY: 50, STERILER, CE 2292

Name: Z-0777-2024 REF: 126590, MEDLINE, STERILE ULTRASOUND GEL, 0.70 FL oz. (20 mL), QTY: 50, STERILER, CE 2292
Creator: Turkuaz Saglik Hizmetleri Medikal Temizlik Kim. Ur. San. ve Tic. A.S.
Published: 2023-06-09
License: https://open.fda.gov/license/

Turkuaz Saglik Hizmetleri Medikal Temizlik Kimyasal Urun / initiated 2023-06-09 / Open, Classified / root cause: manufacturing process

FDA source

Turkuaz Saglik Hizmetleri Medikal Temizlik Kim. Ur. San. ve Tic. A.S. began a recall of REF: 126590, MEDLINE, STERILE ULTRASOUND GEL, 0.70 FL oz. (20 mL), QTY: 50, STERILER, CE 2292 on 2023-06-09. FDA classified it as Class II and gives the reason as "Sterility of Ultrasound gel can not be guaranteed". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0777-2024
Classification: Class II
Status: Open, Classified
Initiated: 2023-06-09
Posted: 2024-01-20
Recalling firm: Turkuaz Saglik Hizmetleri Medikal Temizlik Kimyasal Urun
Product: REF: 126590, MEDLINE, STERILE ULTRASOUND GEL, 0.70 FL oz. (20 mL), QTY: 50, STERILER, CE 2292
Product code: MUI Media, Coupling, Ultrasound
Reason for recall: Sterility of Ultrasound gel can not be guaranteed.
Root cause tag: manufacturing process
FDA 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 [email protected] .
Quantity in commerce: 4,923,471
Distribution: US distribution to: Illinois and OUS (foreign) distribution to: Hong Kong
Product codes and lots: Lot Nos. SJ10091019 SJ22111019 SJ01041120 SJ25081020 SJ25061020 SJ20111020 SJ11021021 SJ24061021 SJ03061021 SJ14071021 SJ20091021 SJ09091021 SJ06022023 SJ10091019

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0777-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0777-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-01-31	2024-01-20

Product code MUI

K130581Class IIKonix Sterile GelTurkuaz Saglik Hizmetleri Medikal Temizlik Kimyasa / cleared 2014-06-18

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)