Agency classClass IIOur severity:Moderate FDA (Devices)·Z-3212-2017·Announced 2017-10-04

Teleflex Recalls LMA MADgic Devices Due to Labeling Deficiencies

Teleflex Medical is recalling LMA MADgic devices because package labels may contain missing or incomplete information.

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 involves minor labeling errors with no reported injuries or illnesses, fitting the criteria for a moderate severity score.

Plain-English summary

Teleflex Medical is recalling specific lots of LMA MADgic Laryngo-Tracheal Mucosal Atomization Devices. The affected products include the MAD600 MADgic, MAD700 MADgic, and MAD720 MADgic models, which are intended for the application of topical anesthetics to the oropharynx and upper airway region.

The recall was initiated because there may be missing or incomplete information on the package labels. A total of 135,456 units were distributed nationwide. The specific lot numbers affected are 161217, 161218, and 161228 for the MAD600; 161119, 161120, 161121, 161153, 161173, 161212, 161223, and 161236 for the MAD700; and 161154 for the MAD720.

Healthcare providers and consumers should check their inventory for these specific lot numbers. If the product is found, it should be removed from use and returned to Teleflex Medical or the distributor in accordance with the recall instructions.

The recalled product

Product: LMA(TM) MADgic(TM) Laryngo-Tracheal Mucosal Atomization Devices: (a) MAD600 MADgic, (b) MAD700 MADgic, (c) MAD720 MADgic Intended for the application of topical anesthetics to the oropharynx and upper airway region
Manufacturer: Teleflex Medical
Category: Medical Device — Airway Management
Hazard: mis-labeling
Affected units: 135,456

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 (10)

Lot Numbers: (a) MAD600 MADgic: 161217
161218
161228 (b) MAD700 MADgic: 161119
161120
161121
161153
161173
161212
161223
161236 (c) MAD720 MADgic: 161154

Distribution

Distributed nationwide across the United States.

Same manufacturer · Teleflex Medical

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