Teleflex Laryngo-Tracheal Mucosal Atomization Device Recalled for Labeling Defects
Teleflex Medical is recalling 25 units of the LMA MADgic device due to missing or incomplete information on the package label.
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, but the source text explicitly identifies the cause as missing or incomplete label information without reporting any injuries, illnesses, or functional defects, aligning with the rubric for minor labeling errors.
Plain-English summary
Teleflex Medical Europe Ltd is recalling 25 units of the Teleflex MEDICAL LMA(TM) MADgic(TM) LARYNGO-TRACHEAL MUCOSAL ATOMIZATION DEVICE, model MAD700. The recall is limited to Lot Number 161212, which was distributed in Texas.
The recall was initiated because there may be missing or incomplete information on the package label. The device is intended for the application of topical anesthetics to the oropharynx and upper airway region.
No specific instructions for consumers or healthcare providers are provided in the source text regarding immediate actions to take.
The recalled product
- Product
- Teleflex MEDICAL LMA(TM) MADgic(TM) LARYNGO-TRACHEAL MUCOSAL ATOMIZATION DEVICE, MAD700, QTY: 1 Intended for the application of topical anesthetics to the oropharynx and upper airway region
- Manufacturer
- Teleflex Medical Europe Ltd
- Hazard
- Affected units
- 25
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)
- Lot Number 161212
Distribution
Distributed in 1 state:
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