Teleflex Medical Recalls LMA MADgic Atomization Devices for Spray Defect
Teleflex Medical is recalling LMA MADgic atomization devices because they may produce a straight stream instead of an atomized plume, potentially causing inadequate anesthesia.
What this means for you
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 explicitly states that serious adverse health consequences are unlikely, fitting the criteria for a moderate severity recall involving a functional defect without reported serious injury.
Plain-English summary
Teleflex Medical is recalling LMA MADgic Atomization Devices with 3mL Syringes. These prescription-only products are used to deliver topical anesthesia via an atomized spray to the oral, nasal, pharyngeal, or laryngeal mucosa. The recall involves 2,674,650 units distributed worldwide, including the United States, Canada, Belgium, Singapore, and Thailand.
The recall is due to a product defect where the devices may produce a straight stream of medication instead of a fully atomized plume. This failure may result in inadequate topical anesthesia, which could lead to patient discomfort, further attempts to deliver anesthesia, or the use of alternative anesthesia methods. The source text notes that it is unlikely that serious adverse health consequences will occur in the event of this failure.
Healthcare providers and patients should stop using the affected lots and contact Teleflex Medical for further instructions. The affected product codes and lot numbers are listed in the official recall notice.
The recalled product
- Product
- LMA MADgic, Atomization Device with 3mL Syringe, Rx only, Product Usage: These products are used for the delivery of topical anesthesia via an atomized spray to the oral, nasal, pharyngeal or laryngeal mucosa. Teleflex Medical is recalling these products as they may produce
- Manufacturer
- Teleflex Medical
- Affected units
- 2,674,650
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 (20)
- Product Code: MAD600
- Lot# 160110
- 160119m
- 160128
- 160140
- 160207
- 160228
- 160304
- 160411
- 160442
- 160525
- 160703 and 160807
- Product Code: MAD700
- Lot# 160111
- 160129
- 160141
- 160209
- 160233
- 160316
- 160329
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 7 recalled by Teleflex Medical under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 7 products in this recall →Related recalls
Same manufacturer · Teleflex Medical
See all →- LowTeleflex RuSCH Male External Catheter Recalled for Incorrect Sterility Labeling
FDA (Devices) · 2020-01-22
- LowTeleflex RuSCH Male External Catheter Recalled for Incorrect Sterility Labeling
FDA (Devices) · 2020-01-22
- ModerateTeleflex Sheridan Endobronchial Tubes Recalled for Incorrect Labeling
FDA (Devices) · 2019-12-25
- HighTeleflex Recalls Arrow EZ-IO Intraosseous Vascular Access System Needles
FDA (Devices) · 2019-12-25
- HighTeleflex Recalls Arrow EZ-IO Intraosseous Vascular Access System Needles
FDA (Devices) · 2019-12-25
Same hazard · inadequate anesthesia
See all →- ModerateTeleflex Medical Recalls Flexi Nozzle Short Sprayers for Anesthesia Delivery
FDA (Devices) · 2016-12-28
- ModerateTeleflex Recalls LMA MADomizer Sprays Due to Inadequate Atomization
FDA (Devices) · 2016-12-28
- ModerateTeleflex Recalls LMA MADdy Topical Anesthesia Sprays Due to Delivery Defect
FDA (Devices) · 2016-12-28
- ModerateTeleflex Medical Recalls Flexi Nozzle Long Sprayers for Inadequate Atomization
FDA (Devices) · 2016-12-28
- ModerateTeleflex Recalls LMA MADett Endotracheal Tubes for Inadequate Anesthesia Delivery
FDA (Devices) · 2016-12-28