Agency classClass IIOur severity:Moderate FDA (Devices)·Z-1085-2015·Announced 2015-02-18

Teleflex Recalls LMA Supreme Size 5 Due to Potential Size 4 Mislabeling

Teleflex Medical is recalling 2,640 units of LMA Supreme (New Cuff) Size 5 devices because some may be mislabeled as Size 5 but are actually Size 4.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

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, which typically corresponds to a moderate severity score. The hazard is a labeling error (mislabeling) rather than a direct contamination or structural defect, and no injuries or illnesses are reported in the source text.

Plain-English summary

Teleflex Medical is recalling 2,640 units of LMA (Laryngeal Mask Airway) Supreme (New Cuff) Size 5, sterile, single-use devices. The recall is due to a labeling error where units from the affected lot are labeled as Size 5 but may actually contain Size 4 devices.

The affected devices are identified by Catalog No. 175050 and Lot no. HMAUGK. These devices were distributed worldwide, including in the United States (AZ, CA, DE, FL, GA, IL, KY, MO, NY, OK, PA, TX, VA, and WA) and Canada. The LMA Supreme is used to achieve and maintain control of the airway during routine anesthesia, cardiopulmonary resuscitation, and failed intubation situations.

Healthcare providers should stop using the affected devices and contact Teleflex Medical for instructions on return or replacement. Patients who have received these devices should consult their healthcare provider if they have concerns regarding the size of the airway device used.

The recalled product

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…
Manufacturer: Teleflex Medical
Category: Medical Device — Airway Management
Hazard: mis-labeling
Affected units: 2,640

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 (2)

Catalog No(s): 175050
Lot no. HMAUGK

Distribution

Distributed nationwide across the United States.

The notice also names 14 states specifically:

Same manufacturer · Teleflex Medical

See all →

Low
Teleflex RuSCH Male External Catheter Recalled for Incorrect Sterility Labeling
FDA (Devices) · 2020-01-22
Low
Teleflex RuSCH Male External Catheter Recalled for Incorrect Sterility Labeling
FDA (Devices) · 2020-01-22
Moderate
Teleflex Sheridan Endobronchial Tubes Recalled for Incorrect Labeling
FDA (Devices) · 2019-12-25
High
Teleflex Recalls Arrow EZ-IO Intraosseous Vascular Access System Needles
FDA (Devices) · 2019-12-25
High
Teleflex Recalls Arrow EZ-IO Intraosseous Vascular Access System Needles
FDA (Devices) · 2019-12-25

Same hazard · mis labeling