BOMImed Laryngoscope Handle Recalled for Intermittent Lighting
Bomimed is recalling specific lots of Disposable Fiber Optic Medium Laryngoscope Handles due to a potential for intermittent lighting during use.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the source text describes a functional defect (flickering) without reporting any injuries, illnesses, or deaths, fitting the criteria for a moderate severity recall.
Plain-English summary
Bomimed is recalling specific lots of BOMImed Disposable Fiber Optic Medium Laryngoscope Handles. The recall involves 680 units distributed in the United States and 2,220 units distributed outside the United States. The affected units are identified by part number OL-334L6 and lot numbers 2216, 3016, 4016, and 4816.
The recall is being conducted because of a potential for intermittent lighting, or flickering, during use. The device is a rigid laryngoscope handle used with a blade to examine and visualize a patient's airway and aid in the placement of a tracheal tube.
The affected units were distributed in Illinois, Pennsylvania, and Washington in the United States, as well as in Canada. Healthcare facilities and users should check their inventory for the specific part and lot numbers listed and stop using the affected devices.
The recalled product
- Product
- BOMImed Disposable Fiber Optic Medium Laryngoscope Handle. Each handle is packaged in an individual peel pouch, 20 handles per box. The rigid laryngoscope handle is a device used along with a blade to examine and visualize a patient's airway and aid placement of a tracheal…
- Manufacturer
- Bomimed
- Category
- Medical Device — Laryngoscope
- 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)
- Part number: OL-334L6 Lot#: 2216
- 3016
- 4016 and 4816
Distribution
Distribution scope not specified by the agency.
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