Seiler Alpha Air 6 ENT Microscope Recalled for Tipping Hazard
Seiler Instruments is recalling Alpha Air 6 ENT Microscopes because they may tip over if attachments are extended and the device is moved improperly.
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 (tipping over) where injury has not yet been reported, fitting the High severity criteria for potential physical harm without confirmed incidents.
Plain-English summary
Seiler Instr. & Mfg. Co. Inc. is recalling the Alpha Air 6 ENT Microscope, a device used for the examination of the human ear, nose, and throat. The recall involves 43 units, with 1 unit identified as affected. The product was distributed worldwide, including to specific US states (CA, CO, FL, IL, MN, NV, OK, TX) and numerous international countries.
The recall is due to a safety hazard where the microscope may tip over if attachments are fully extended in one line and there is an attempt to move the device not by the handles mounted on the post. This instability poses a risk of injury or property damage if the device falls.
Healthcare providers and consumers with this device should stop using it immediately. They should contact Seiler Instr. & Mfg. Co. Inc. for instructions on how to return the product or receive a repair, as appropriate.
The recalled product
- Product
- Alpha Air 6 ENT Microscope Microscope examination of the human ear, nose, and throat.
- Manufacturer
- Seiler Instr. & Mfg. Co. Inc.
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 (1)
- Model Number 6 ENT
Distribution
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