Cleaner Bottles May Disassemble Under Pressure During Treatment
EMS CLEANER BOTTLES (Model EG-1000) for dental prophylaxis systems may disassemble under pressure during treatment or storage. FDA Class II recall; no injuries 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 recall with a structural assembly defect that could prevent proper device function. No injuries or illnesses reported, meeting the rubric criterion for High severity (risk-of-harm product where injury has not yet been reported).
Plain-English summary
The FDA is recalling EMS CLEANER BOTTLES (Model EG-1000), which are used with AIRFLOW PROPHYLAXIS MASTER and AIRFLOW ONE dental prophylaxis systems to clean water lines.
The recall involves bottles assembled with certain bottle collars that can separate into two parts when used under pressure during treatment or storage. This separation can occur if internal pressure is not released.
Approximately 342 units were distributed worldwide, including in the United States (Illinois and Texas). The affected lot is identified by lot number 16442-210 (Model EG-1000) with expiration date April 2026. A complete list of affected serial numbers is available from the manufacturer.
Users of affected bottles should discontinue use and contact Electro Medical Systems SA for a replacement. No injuries or illnesses have been reported in connection with this recall.
The recalled product
- Product
- Brand Name: CLEANER BOTTLE Product Name: CLEANER BOTTLE Model/Catalog Number: EG-1000 Software Version: N/A Product Description: CLEANER bottles used with EMS AIRFLOW PROPHYLAXIS MASTER / EMS AIRFLOW ONE devices to clean the water lines. The bottle is placed on the device du
- Manufacturer
- Electro Medical Systems SA
- Hazard
- assembly-defect
- pressure-failure
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-1000
- UDI: 07613353180225
- Lot number: 16442-210
Distribution
Distributed nationwide across the United States.
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