FDAMarch 13, 2024device

Brand Name: WATER BOTTLE Product Name: WATER BOTTLE Model/Catalog Number: EG-121 Software Version: N/A Product Description: These bottles are sold empty and are filled by the user with water fort dental treatments. The bottle is pressurized on the device during use. Component: YES. AIRFLOW PROPHY...

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

Received complaints that bottles assembled with one batch of bottle collars can be disassembled in two parts when used under pressure (during treatment or storage if the use is not releasing the pressure inside the bottles).

What to do

FDA enforcement status: Ongoing

Brands named

electro medical systems saelectroelectro medical

UPCs

07613353180287076133532131830761335318414807613353184124

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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