FDA Device recall Z-2275-2025
One-piece Guedel airway, size 2, ISO 8.0, green
- FDA Device
- Class II
- ongoing
- Published 2025-08-13
On 2025-08-13 the FDA classified a Class II recall of One-piece Guedel airway, size 2, ISO 8.0, green by Intersurgical, citing potential contamination with small burrs, which if detach could be inhaled and result in potential complications such as airway obstruction, tissue irritation, inflammation and in….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2275-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-06-20 |
| Published | 2025-08-13 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Intersurgical |
| Distribution | AZ, CA, CT, FL, HI, MA, MI, OH, UT, VA |
Product
One-piece Guedel airway, size 2, ISO 8.0, green. Model Number: 1112080.
Reason
Potential contamination with small burrs, which if detach could be inhaled and result in potential complications such as airway obstruction, tissue irritation, inflammation and infection.
Identifiers
| code_info | Model Number: 1112080. UDI-DI (Case): 05030267040698, UDI-DI (Single Unit): 5030267050659. Lot Number: 32414447 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Other recalls by Intersurgical
- One-Piece Guedel Airway, size 000, ISO 3.5, Light Green
FDA Device · Class II · 2026-08-26 · Intersurgical - One-Piece Guedel Airway, size 00, ISO 5.0, Blue
FDA Device · Class II · 2026-08-26 · Intersurgical - One-piece Guedel airway, size 3, ISO 9.0, yellow
FDA Device · Class II · 2025-08-13 · Intersurgical - i-view video laryngoscope
FDA Device · Class I · 2025-07-23 · Intersurgical - Intersurgical Solus Standard, laryngeal mask airway, size 3, small adult, 30-50kg Model Number: 8003000
FDA Device · Class II · 2022-10-26 · Intersurgical
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2275-2025%22
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