FDA Enforcement Class II Ongoing

Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit 20 Fr PULL Model/Catalog Number: 7180-20

Recall: Z-2345-2026 · Reported June 17, 2026

Enforcement

Recall Number
Z-2345-2026
Event ID
98907
Classification
Class II
Status
Ongoing
Product Type
Devices
Firm
Avanos Medical, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Initial Notification
N/A
Report Date
June 17, 2026
Initiation Date
April 30, 2026
Classification Date
June 5, 2026
Address
5405 Windward Pkwy, N/A, Alpharetta, GA, 30004-4667, United States

Description

Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit 20 Fr PULL Model/Catalog Number: 7180-20

Reason

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

Code Info

UDI-DI 10350770007783, Lot Numbers 30371313, 30371314, 30373295, 30373296, 30374832, 30378735, 80403340

Distribution

US Nationwide distribution.

Quantity

3,184 kits