The Recall Desk
ModerateFDA (Devices)·Z-0381-2017·Announced 2016-12-28

Teleflex Recalls LMA MADomizer Sprays Due to Inadequate Atomization

Teleflex Medical is recalling LMA MADomizer 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, but the source explicitly states that serious adverse health consequences are unlikely and the primary risk is inadequate anesthesia leading to discomfort or procedural adjustments, fitting the criteria for a moderate, precautionary recall.

Plain-English summary

Teleflex Medical is recalling LMA MADomizer products, which are used to deliver topical anesthesia via an atomized spray to the oral, nasal, pharyngeal, or laryngeal mucosa. The recall is due to a defect where the devices may produce a straight stream of medication instead of a fully atomized plume.

The affected products include Product Code MAD500 (Lots 160127, 160314, 160441, 160508, 160632, and 160805) and Product Code MAD510 (Lots 160109, 160115, 160206, 160220, 160227, 160303, 160315, 160323, 160328, 160401, 160426, 160501, 160519, 160603, 160612, 160622, 160633, 160702, 160719, and 160808). A total of 2,674,650 units were distributed worldwide, including in the United States, Canada, Belgium, Singapore, and Thailand.

The FDA classifies this as a Class II recall. The source text states that it is unlikely that serious adverse health consequences will occur, but the failure to deliver an atomized plume may result in inadequate topical anesthesia. This could lead to discomfort, further attempts to deliver anesthesia, or the use of alternative methods.

The recalled product

Product
LMA MADomizer, 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 ful
Manufacturer
Teleflex Medical
Category
Medical Device — Anesthesia Delivery
Hazard
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: MAD500
  • Lot # 160127
  • 160314
  • 160441
  • 160508
  • 160632 and 160805
  • Product Code: MAD510
  • Lot# 160109
  • 160115
  • 160206
  • 160220
  • 160227
  • 160303
  • 160315
  • 160323
  • 160328
  • 160401
  • 160426
  • 160501
  • 160519

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 →

Same hazard · inadequate anesthesia

See all →