Teleflex Medical Recalls Flexi Nozzle Long Sprayers for Inadequate Atomization
Teleflex Medical is recalling Flexi Nozzle Long sprayers 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, but the source explicitly states that serious adverse health consequences are unlikely and the primary risk is inadequate anesthesia leading to discomfort or alternative methods, fitting the criteria for a moderate, precautionary recall.
Plain-English summary
Teleflex Medical is recalling 2,674,650 units of Flexi Nozzle Long products. These devices are used to deliver topical anesthesia via an atomized spray to the oral, nasal, pharyngeal, or laryngeal mucosa. The recall covers specific lots (160118, 160324, 160509, 160709, 160810, and 160833) with product code MAD510L.
The recall was initiated because the products may produce a straight stream instead of a fully atomized plume of medication. This defect may result in inadequate topical anesthesia, which could lead to discomfort, further attempts to deliver anesthesia, or the use of alternative methods. The FDA classifies this as a Class II recall, noting that it is unlikely that serious adverse health consequences will occur.
The affected products were distributed worldwide, including nationwide in the U.S. and internationally to Canada, Belgium, Singapore, and Thailand. Users should stop using the affected products and contact Teleflex Medical for further instructions.
The recalled product
- Product
- FLEXI NOZZLE LONG, 10 Boxes of 25 units each 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 str
- 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 (6)
- Product Code: MAD510L
- Lot# 160118
- 160324
- 160509
- 160709
- 160810 and 160833.
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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