Z-2337-2026 Class II Ongoing
FDA device recall Z-2337-2026 was initiated by Avanos Medical, Inc. on April 30, 2026 and is designated Class II. Reason for recall: Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets. The recall status is ongoing. Affected quantity: 49 kits.
Recall Details
- Product Type
- Devices
- Report Date
- June 17, 2026
- Initiation Date
- April 30, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 49 kits
Product Description
Product Name: CORFLO* Safety PEG Kit with ENFit¿ Connector Model/Catalog Number: 50-4320
Reason for Recall
Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.
Distribution Pattern
US Nationwide distribution.
Code Information
UDI-DI 10350770007578, Lot Numbers 30365230, 30367013, 30373825