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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Diagnostic Equipment

Turkuaz Saglik Hizmetleri Medikal Temizlik Kim. Ur. San. ve Tic. A.S.: Sterile Ultrasound Gel Recalled Due to Compromised Sterility

Agency Publication Date: January 20, 2024
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Summary

Approximately 4.9 million units of Medline Sterile Ultrasound Gel (0.70 FL oz. packets) are being recalled because the sterility of the gel cannot be guaranteed. Using a non-sterile product in medical procedures that require sterility can lead to serious infections and health complications for patients. These products were distributed to Illinois and Hong Kong between June 2023 and early 2024.

Risk

The manufacturer cannot ensure that the gel is free from microbial contamination, which poses a significant risk of infection if used during sterile medical procedures or on broken skin.

What You Should Do

  1. Identify your product by checking for 'MEDLINE STERILE ULTRASOUND GEL' in 0.70 FL oz. (20 mL) individual packets or boxes of 50 (REF: 126590).
  2. Verify the lot number on the packaging against the affected list: SJ10091019, SJ22111019, SJ01041120, SJ25081020, SJ25061020, SJ20111020, SJ11021021, SJ24061021, SJ03061021, SJ14071021, SJ20091021, SJ09091021, or SJ06022023.
  3. Immediately stop using any affected gel packets and isolate them from your active medical supply to prevent accidental use.
  4. Contact your healthcare provider or the manufacturer, Turkuaz Saglik Hizmetleri, for further instructions regarding the disposal or return of the product and to discuss potential refunds.
  5. For additional information, contact the FDA at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

๐Ÿ“‹Other Action

Contact manufacturer for instructions

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: Medline Sterile Ultrasound Gel (0.70 FL oz. / 20 mL)
Model / REF:
126590
CE 2292
Lot Numbers:
SJ10091019
SJ22111019
SJ01041120
SJ25081020
SJ25061020
SJ20111020
SJ11021021
SJ24061021
SJ03061021
SJ14071021
SJ20091021
SJ09091021
SJ06022023

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 93580
Status: Active
Manufacturer: Turkuaz Saglik Hizmetleri Medikal Temizlik Kim. Ur. San. ve Tic. A.S.
Sold By: Medline
Manufactured In: Turkey
Units Affected: 4,923,471
Distributed To: Illinois

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.