Teleflex Medical: Medical Device Recall in 2015 - (Recall #: Z-1085-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

LMA (Laryngeal Mask Airway) Supreme (New Cuff) Size 5, Sterile, Single use, Product Usage: Achieve and maintain control of airway during routine anaesthesia in fasted patient using either spontaneous or positive pressure ventilation, cardiopulmonary resuscitation, the failed intubation situation and the cannot-intubate-cannot-ventilate situation.

Product Classification:

Class II

Date Initiated: January 13, 2015

Date Posted: February 18, 2015

Recall Number: Z-1085-2015

Event ID: 70258

Reason for Recall:

The labelling of units from the affected lot indicates that it contains a size 5 LMA Supreme (New Cuff), but may contain a size 4 LMA Supreme (New Cuff).

Status: Terminated

Product Quantity: 2640 units

Code Information:

Catalog No(s): 175050, Lot no. HMAUGK

Distribution Pattern:

Worldwide Distribution - U.S Nationwide in the states of: AZ, CA, DE, FL, GA, IL, KY, MO, NY, OK, PA, TX, VA & WA and the country of Canada.

Voluntary or Mandated:

Voluntary: Firm initiated