Z-2952-2026 Class II Ongoing
FDA device recall Z-2952-2026 was initiated by Intersurgical Inc on June 15, 2026 and is designated Class II. Reason for recall: Devices could potentially be occluded or partially occluded. The recall status is ongoing. Affected quantity: 21,269 units.
Recall Details
- Product Type
- Devices
- Report Date
- August 26, 2026
- Initiation Date
- June 15, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 21,269 units
Product Description
One-Piece Guedel Airway, size 00, ISO 5.0, Blue. Oropharyngeal Airway Device.
Reason for Recall
Devices could potentially be occluded or partially occluded.
Distribution Pattern
US Nationwide distribution in the states of CT, FL, IN, MI, OH & VA.
Code Information
REF: 1100050; Single Unit UDI: 5030267050185; Case UDI: 05030267044450; Lot No. 32121232, 32208193, 32400267, 32403734, 32408819, 32409672, 32416545, 32427064, 32605471, 32606405, 32606850, 32607154.