Water bottles used in dental treatment devices recalled for disassembly risk
Electro Medical Systems is recalling water bottles used with AIRFLOW dental devices because certain bottle collars can disassemble under pressure 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: This is a Class II medical device recall for a pressurized component with a structural defect capable of causing device malfunction. The hazard is a risk-of-harm product where injury has not yet been reported, meeting the High severity criterion.
Plain-English summary
Electro Medical Systems SA is recalling water bottles (Model EG-121) used with AIRFLOW PROPHYLAXIS MASTER and AIRFLOW PROPHYLAXIS ONE dental devices. These empty bottles are filled by users with water for dental treatments and become pressurized during use.
Some bottles assembled with certain bottle collars can disassemble into two parts when exposed to pressure—either during active treatment or during storage if the internal pressure is not released. This structural failure can result in loss of pressurization and device malfunction.
Approximately 462 units were affected and distributed worldwide, including to the United States (Illinois and Texas) and numerous countries internationally. Affected units are identified by specific lot numbers and serial numbers listed in the recall notice.
Consumers and healthcare providers should discontinue use of affected bottles and check serial numbers and lot codes to determine if their products are affected. Contact the manufacturer for more information.
The recalled product
- Product
- 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. Componen
- Manufacturer
- Electro Medical Systems SA
- Hazard
- disassembly
- pressure-loss
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 (11)
- Lot Code: Model number: EG-121
- UDI: 07613353180287 Lot number: 16457-10
- Expiry date: 2026-04 Model number: EG-121
- UDI: 07613353180287 Lot number: 16457-80
- UDI: 07613353180287 Lot number: 16457-120
- Expiry date: 2026-07 Model number: EG-121
- UDI: 07613353180287 Lot number: 16457-130
- Expiry date: 2026-10 Model number: EG-121
- UDI: 07613353180287 Lot number: 16457-140
- UDI: 07613353180287 Lot number: 16866-80
- Expiry date: 2026-10: batch not impacted by the deviation
Distribution
Distributed nationwide across the United States.
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