FDA Device recall Z-1085-2015
LMA (Laryngeal Mask Airway) Supreme (New Cuff) Size 5, Sterile, Single use, Product Usage: Achieve and maintain control of airway during ro…
- FDA Device
- Class II
- terminated
- Published 2015-02-18
On 2015-02-18 the FDA classified a Class II recall of LMA (Laryngeal Mask Airway) Supreme (New Cuff) Size 5, Sterile, Single use, Product Usage: Achieve and maintain control of airway during ro… by Teleflex Medical, citing 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).
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1085-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-01-13 |
| Published | 2015-02-18 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Teleflex Medical |
| Distribution | US |
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.
Reason
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).
Identifiers
| code_info | Catalog No(s): 175050, Lot no. HMAUGK |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1085-2015%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.