Z-1085-2015Class II

LMA (Laryngeal Mask Airway) Supreme (New Cuff) Size 5, Sterile, Single use

Name: Z-1085-2015 LMA (Laryngeal Mask Airway) Supreme (New Cuff) Size 5, Sterile, Single use
Creator: Teleflex Medical
Published: 2015-01-13
License: https://open.fda.gov/license/

Teleflex Medical / initiated 2015-01-13 / Terminated / root cause: labeling and UDI

FDA source

Teleflex Medical began a recall of LMA (Laryngeal Mask Airway) Supreme (New Cuff) Size 5, Sterile, Single use, Product Usage: Achieve and maintain control of airway during routine anaesthesia in... on 2015-01-13. FDA classified it as Class II and gives the reason as "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)". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1085-2015
Classification: Class II
Status: Terminated
Initiated: 2015-01-13
Posted: 2015-02-10
Terminated: 2016-09-27
Recalling firm: Teleflex Medical
Product: 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 code: CAE Airway, Oropharyngeal, Anesthesiology
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).
Root cause tag: labeling and UDI
FDA root cause: Other
Action: Teleflex sent an Urgent Medical Device Recall Notification letter dated January 13, 2015 to affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to immediately discontinue use and quarantine any products and to return it to Teleflex Medical. Customers were asked to complete the enclosed Recall Acknowledgement Form via fax even if they do not have the affected product in stock. For questions contact your local sales representative or Customer Service at 1-866-246-6990.
Quantity in commerce: 2640 units
Distribution: 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.
Product codes and lots: Catalog No(s): 175050, Lot no. HMAUGK

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1085-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1085-2015	Class II	Terminated	Voluntary: Firm initiated	2015-02-18	2015-02-10

Product code CAE

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)