FDA Medical devices recall ·
CORFLO* Safety PEG Kit with ENFit¿ Connector Model recall
- Recall number
- Z-2339-2026
- Date
- (initiated April 30, 2026)
- Company / brand
- Avanos Medical, Inc.
5405 Windward Pkwy, Alpharetta, GA, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 43 kits
- Hazard tags
- Sterility
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Product Name: CORFLO* Safety PEG Kit with ENFit¿ Connector Model/Catalog Number: 50-6312
Why was it recalled?
Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
UDI-DI 10350770007523, Lot Numbers 30365232, 30367019, 30380107
Distribution
US Nationwide distribution.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-2339-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.