← FDA ENFORCEMENT
Z-2350-2026Class II

Avanos Medical, Inc.

Recalling firm
Avanos Medical, Inc.
Product type
Device
Status
Ongoing
Report date
2026-06-17
Distribution
US Nationwide distribution.
Firm state
GA
Product quantity
218 kits
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Environmental Monitoring
Reason for recall

Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.

Product description

Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit Connectors 14 Fr PULL Model/Catalog Number: 8180-14

Code / lot info

UDI-DI 10350770007844, Lot Numbers 30371318, 30375469, 30383056

Other recalls SPEQ maps to Environmental Monitoring
2026-07-22Class IFrutas y Hortalizas del Sur S.A.2026-07-22Class IIGELLERT GLOBAL GROUP2026-07-22Class IIChiesi USA, Inc.2026-07-22Class IICareFusion 213, LLC
See all Environmental Monitoring recalls →

Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.