Recall Z-2348-2026— Avanos Medical, Inc.

Name: FDA recall Z-2348-2026
Creator: U.S. Food and Drug Administration
Published: 2026-04-30

Class II · Ongoing

Class II FDA medical device recall by Avanos Medical, Inc., initiated 2026-04-30. It names one FDA 510(k) clearance: K924065. Product: Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit Connectors 20 Fr PUSH OTW Model/Catalog Number: 8170-20. Reason: Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets..

Recalling firm: Avanos Medical, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2026-04-30
Firm location: Alpharetta, GA, United States

510(k) clearances named in this recall

1 on FDA's record

K924065 — MIC PEG TUBEMedical Innovations Corp.·cleared 1994-02-17

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit Connectors 20 Fr PUSH OTW Model/Catalog Number: 8170-20

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.