FDA-Device2026-06-17Class IIPROCESSING DEFECT
Avanos CORFLO Safety PEG Kit recalled for defective lidocaine injection
What this means
Avanos Medical included lidocaine hydrochloride injection with quality issues into CORFLO Safety PEG Kit sterile sets. The lidocaine was subject to a supplier recall for manufacturing defects. Sixty-one kits with six lot numbers were affected.
- Check your kit lot number against: 30365227, 30368642, 30374529, 30376099, 30380696, or 30387248.
- If you have an affected lot, stop use and contact your supplier or Avanos Medical for replacement or guidance.
- Do not use the lidocaine injection from affected kits.
The agency's original wording
Hazard
Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.
Intended for
Adults
Illnesses reported
None reported
Sold states
US Nationwide distribution.
Affected count
61 kits
Manufactured in
5405 Windward Pkwy, N/A, Alpharetta, GA, United States
Products
Brand Name: CORFLO Product Name: CORFLO Safety PEG Kit Model/Catalog Number: 30-5320
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2334-2026Want us to check the next one for you?
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