ClearanceBrief
Recall Z-2348-2026 ยท KNT Tubes, Gastrointestinal (And Accessories)

Avanos Medical, Inc.

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

DateJun 5, 2026 (initiated Apr 30, 2026)
StatusOpen, Classified
ReasonLidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.
Root causeMaterial/Component Contamination
ActionOn May 1, 2026, Avanaos Medical, Inc. issued a "Urgent: Medical Device Recall" Notification to affected consignees via Email. Avanos asked consignees to take the following actions: 1. Immediately review your inventory and identify any affected product. 1a. Quarantine all affected lots to prevent further use or distribution. 1b. Discontinue use of the affected lidocaine hydrochloride injection 1%, 5 mL and return the entire unused kit to Avanos Medical, Inc. for destruction. 2. This notice needs to be passed on to all those who need to be aware within your organization or functions where the p
Quantity1,615 kits
DistributionUS Nationwide distribution.
FDA recordOpen on fda.gov

510(k) clearances named in this recall

K924065MIC PEG TUBE
Medical Innovations Corp., Feb 17, 1994