FDA recall Z-2349-2026

Avanos Medical, Inc. · Class II · device

Product

Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit Connectors 24 Fr PUSH OTW Model/Catalog Number: 8170-24

Reason for recall

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

Distribution

US Nationwide distribution.

Key facts

Status
Ongoing
Initiation date
2026-04-30
Report date
2026-06-17
Voluntary/Mandated
Voluntary: Firm initiated
Location
Alpharetta, GA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2349-2026