Teleflex Recalls LMA MADdy Topical Anesthesia Sprays Due to Delivery Defect
Teleflex Medical is recalling LMA MADdy topical anesthesia sprays 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 explicitly states that serious adverse health consequences are unlikely, with the primary risk being inadequate anesthesia and discomfort, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Teleflex Medical is recalling LMA MADdy topical anesthesia sprays, which are prescription-only devices used to deliver medication 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 affected products are identified by Product Code MAD800 (Lot# 160208 and 160625) and Product Code MAD900 (Lot# 160605).
The recall was initiated because the devices may produce a straight stream of medication instead of a fully atomized plume. According to the source, it is unlikely that serious adverse health consequences will occur, but the defect may result in inadequate topical anesthesia. This could lead to patient discomfort, the need for further attempts to deliver anesthesia, or the use of alternative anesthesia methods.
Healthcare providers and patients should check their inventory for the specific product codes and lot numbers listed above. If the affected units are found, they should stop using them and contact Teleflex Medical for instructions on return or replacement.
The recalled product
- Product
- LMA MADdy, 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 a straight stream instead of a fully a
- 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 (3)
- Product Code: MAD800
- Lot# 160208 and 160625 and Product Code: MAD900
- Lot# 160605.
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.
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