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

Recall Insight

This FDA Devices action (record #Z-0777-2024) was formally reported on January 31, 2024, with the manufacturer initiating the action on June 9, 2023. It is classified under Moderate severity (Class II), with a current status of Ongoing. Turkuaz Saglik Hizmetleri Medikal Temizlik Kim. Ur. San. ve Tic. A.s. is listed as the recalling firm, operating out of Esenyurt, N/A. Federal records indicate 4,923,471 units are affected, placing this recall in the million-unit bracket that typically triggers nationwide consumer alerts and retailer sweeps.

The documented reason for this recall is: Sterility of Ultrasound gel can not be guaranteed. Distribution data in the federal record shows the product reached: US distribution to: Illinois and OUS (foreign) distribution to: Hong Kong. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC and NHTSA going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 6 were also issued by FDA Devices. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 2 years old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.