PIEZON Bottle May Disassemble Under Pressure During Dental Use
FDA recalls PIEZON Bottle (Model EG-111) dental treatment bottles because certain units may separate into two parts when pressurized during treatment or storage. No injuries have been reported.
What this means for you
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: FDA Class II medical device with a functional defect (disassembly under pressure) that creates risk of harm during pressurized use in dental procedures. No reported injuries or illnesses; the hazard is theoretical rather than confirmed.
Plain-English summary
Electro Medical Systems SA is recalling PIEZON Bottle (Model EG-111), an empty dental treatment bottle that is filled by users with water or small quantities of disinfectant solutions. The bottle becomes pressurized during dental treatment procedures and is used as a component in AIRFLOW Prophylaxis Master and AIRFLOW Prophylaxis One devices.
The recall addresses bottles assembled with one batch of bottle collars that can disassemble into two separate parts when under pressure. Disassembly may occur during active dental treatment or while the bottle is in storage if internal pressure has not been fully released.
The affected bottles were distributed worldwide, with U.S. distribution in Illinois and Texas. A total of 54 units were identified in the recall across multiple lot numbers and serial numbers.
No injuries or illnesses have been reported to date. Users should stop using affected units identified by their serial numbers and contact the manufacturer for guidance on replacement. Dental practitioners should verify their equipment serial numbers against the recall list before continuing use.
The recalled product
- Product
- Brand Name: PIEZON Bottle Product Name: PIEZON Bottle Model/Catalog Number: EG-111 Software Version: N/A Product Description: These bottles are sold empty and are filled by the user with water - in some cases small quantities of disinfectant solutions - for dental treatments.
- Manufacturer
- Electro Medical Systems SA
- Hazard
- device-disassembly
- pressure-hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Lot Code: Model number: EG-111
- UDI: 07613353180249 Lot number: 16442-190
- Expiry date: 2026-04 Model number: EG-111
Distribution
Distributed nationwide across the United States.
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