Bien Air Dental Contra-Angles Recalled for Potential Tool Loosening
Bien Air Dental SA is recalling specific EVO 15 contra-angles because the dental tool may loosen and be swallowed.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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: The recall involves a risk-of-harm product (swallowing a dental tool) where injury has not yet been reported, which aligns with the High severity criteria.
Plain-English summary
Bien Air Dental SA is recalling 112 units of Contra-Angles CA1:1L EVO 15 in the United States. The affected products are identified by catalog numbers 1600939-001 and 1600938-001. The recall covers serial numbers 15B0001 through 15F0011 for catalog number 1600939-001 and serial numbers 15B0007 through 15F0027 for catalog number 1600938-001.
The recall is being conducted because the dental tool may loosen, which could lead to the potential swallowing of the tool. These devices are used for general dentistry procedures. The products were distributed worldwide, with U.S. distribution limited to one distributor in Florida.
Dental professionals and consumers should stop using the affected contra-angles immediately. Users should check their inventory for the specific catalog and serial numbers listed in this notice to determine if they possess the recalled items.
The recalled product
- Product
- Contra-Angles CA1:1L EVO 15 Catalog numbers: 1600939-001 and 1600938-001 Used for generally dentistry procedures
- Manufacturer
- Bien Air Dental SA
- Hazard
- Affected units
- 112
Distribution
Distributed in 1 state:
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