CLASS II ONGOING Device recall · Reported 31 Jan 2024 · FDA Enforcement Report
REF: 126590, Medline, Sterile Ultrasound GEL, 0.70 FL oz. (20 mL) recalled
Turkuaz Saglik Hizmetleri Medikal Temizlik Kim. Ur. San. ve Tic. A.S is recalling REF: 126590, Medline, Sterile Ultrasound GEL, 0.70 FL oz. (20 mL), distributed in Illinois. The recall was initiated on 9 Jun 2023 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0777-2024
- FDA event ID
- 93580
- Recalling firm
- Turkuaz Saglik Hizmetleri Medikal Temizlik Kim. Ur. San. ve Tic. A.S, Esenyurt, N/A
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 9 Jun 2023
- FDA classified
- 20 Jan 2024
- Reported
- 31 Jan 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Sterility
- Device type
- Imaging Equipment
Timeline
| 9 Jun 2023 | Recall initiated by company | |
| 20 Jan 2024 | Classified by FDA | +225 days |
| 31 Jan 2024 | Published in enforcement report | +11 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Sterility of Ultrasound gel can not be guaranteed.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
REF: 126590, MEDLINE, STERILE ULTRASOUND GEL, 0.70 FL oz. (20 mL), QTY: 50, STERILER, CE 2292
Where it was distributed
US distribution to: Illinois and OUS (foreign) distribution to: Hong Kong
Questions about this recall
Why was it recalled?
Sterility of Ultrasound gel can not be guaranteed.
Which lots are affected?
Lot Nos. SJ10091019 SJ22111019 SJ01041120 SJ25081020 SJ25061020 SJ20111020 SJ11021021 SJ24061021 SJ03061021 SJ14071021 SJ20091021 SJ09091021 SJ06022023 SJ10091019
Where was it sold?
US distribution to: Illinois and OUS (foreign) distribution to: Hong Kong
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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