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U.S. Department of Health and Human Services

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

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 Class 2 Device Recall MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit Connectorssee related information
Date Initiated by FirmApril 30, 2026
Date PostedJune 05, 2026
Recall Status1 Open3, Classified
Recall NumberZ-2349-2026
Recall Event ID 98907
510(K)NumberK924065 
Product Classification Tubes, gastrointestinal (and accessories) - Product Code KNT
ProductProduct Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit Connectors 24 Fr PUSH OTW Model/Catalog Number: 8170-24
Code Information UDI-DI 10350770007837, Lot Numbers 30371847, 30374834, 30378748, 30380347
FEI Number 3011270181
Recalling Firm/
Manufacturer		 Avanos Medical, Inc.
5405 Windward Pkwy
Alpharetta GA 30004-4667
For Additional Information ContactTamara 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 2		Material/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 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 Commerce234 kits
DistributionUS Nationwide distribution.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = KNT
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