Class 2 Device Recall MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit Connectors

• Date Initiated by Firm: April 30, 2026
• Date Posted: June 05, 2026
• Recall Status: Open, Classified
• Recall Number: Z-2348-2026
• Recall Event ID: 98907
• 510(K)Number: K924065
• Product Classification: Tubes, gastrointestinal (and accessories) - Product Code KNT
• Product: Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit Connectors 20 Fr PUSH OTW Model/Catalog Number: 8170-20
• Code Information: UDI-DI 10350770007820, Lot Numbers 30371324, 30374833, 30384889, 80403350
• FEI Number: 3011270181
• Recalling Firm/ Manufacturer: Avanos Medical, Inc.; 5405 Windward Pkwy; Alpharetta GA 30004-4667
• For Additional Information Contact: Tamara Cardona; 470-448-5000
• Manufacturer Reason for Recall: Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.
• FDA Determined Cause: Material/Component Contamination
• Action: On 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 potentially affected devices have been transferred. 3. Complete and return the Customer Response Form as instructed, including identifying whether you have inventory of the affected product available for return. Distributors: 1. Provide customers a copy of this notification. Instruct customers to follow the actions outlined in this letter. 2. Provide refunds or credits to your customers in accordance with your internal processes. 3. Submit an updated Customer Response Form to Avanos to account for product distributed to your customers and to receive applicable replacement product.
• Quantity in Commerce: 1,615 kits
• Distribution: US Nationwide distribution.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = KNT