FDA Device recall Z-2952-2026
One-Piece Guedel Airway, size 00, ISO 5.0, Blue
- FDA Device
- Class II
- ongoing
- Published 2026-08-26
On 2026-08-26 the FDA classified a Class II recall of One-Piece Guedel Airway, size 00, ISO 5.0, Blue by Intersurgical, citing devices could potentially be occluded or partially occluded.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2952-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-06-15 |
| Published | 2026-08-26 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | Intersurgical |
| Distribution | US |
Product
One-Piece Guedel Airway, size 00, ISO 5.0, Blue. Oropharyngeal Airway Device.
Reason
Devices could potentially be occluded or partially occluded.
Identifiers
| code_info | REF: 1100050; Single Unit UDI: 5030267050185; Case UDI: 05030267044450; Lot No. 32121232, 32208193, 32400267, 32403734,…REF: 1100050; Single Unit UDI: 5030267050185; Case UDI: 05030267044450; Lot No. 32121232, 32208193, 32400267, 32403734, 32408819, 32409672, 32416545, 32427064, 32605471, 32606405, 32606850, 32607154. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2952-2026%22
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