Ultrasound Gel Sterility Cannot Be Guaranteed — FDA Recall
Turkuaz Saglik Hizmetleri is recalling over 4.9 million units of sterile ultrasound gel (REF 126590) because manufacturer cannot guarantee its sterility. Affected products in Illinois and Hong Kong should not be used.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This FDA Class II recall involves a sterile medical device where sterility cannot be guaranteed, creating a risk-of-harm to patients. No illnesses or injuries have been reported, and the hazard is theoretical. Per the rubric, this qualifies as High (3).
Plain-English summary
Turkuaz Saglik Hizmetleri Medikal Temizlik Kim. Ur. San. ve Tic. A.S. is recalling approximately 4.9 million units of MEDLINE sterile ultrasound gel (REF 126590, 0.70 FL oz / 20 mL, packaged in quantities of 50). The product carries CE 2292 marking.
The manufacturer cannot guarantee the sterility of the product. Because ultrasound gel is classified as a sterile medical device, non-sterile product poses a risk of infection if applied to patients, particularly in clinical settings.
The recalled gel was distributed within the United States to Illinois and internationally to Hong Kong. Affected lot numbers include: SJ10091019, SJ22111019, SJ01041120, SJ25081020, SJ25061020, SJ20111020, SJ11021021, SJ24061021, SJ03061021, SJ14071021, SJ20091021, SJ09091021, and SJ06022023.
Healthcare providers and consumers who have the recalled product should discontinue use and contact the manufacturer or their supplier. No illnesses or injuries related to this product have been reported. The FDA classified this recall as Class II.
The recalled product
- Product
- REF: 126590, MEDLINE, STERILE ULTRASOUND GEL, 0.70 FL oz. (20 mL), QTY: 50, STERILER, CE 2292
- Affected units
- 4,923,471
Distribution
Distributed in 1 state:
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