Teleflex Medical: Medical Device Recall in 2016 - (Recall #: Z-0386-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

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 atomized plume of medication. It is unlikely that serious adverse health consequences will occur in the event of a failure to deliver an atomized plume; however, this may result in inadequate topical anesthesia which may lead to some discomfort, further attempts to deliver topical anesthesia, or the use of alternative methods of anesthesia.

Product Classification:

Class II

Date Initiated: October 27, 2016

Date Posted: December 28, 2016

Recall Number: Z-0386-2017

Event ID: 75554

Reason for Recall:

Product Defect; These products may produce a straight stream instead of a fully atomized plume of medication.

Status: Terminated

Product Quantity: 2,674,650 units in total

Code Information:

Product Code: MAD800, Lot# 160208 and 160625 and Product Code: MAD900, Lot# 160605.

Distribution Pattern:

Worldwide distribution. U.S. (Nationwide) and Internationally to Canada, Belgium, Singapore and Thailand.

Voluntary or Mandated:

Voluntary: Firm initiated