Product Name: CORFLO* Safety PEG Kit with ENFit Connector Model/Catalog Number: 50-5320

FDA device recall Z-2338-2026 · posted 2026-06-05 · Open, Classified

Recall details

Recalling firm

Avanos Medical, Inc.

Reason for recall

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

Action taken

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.

Root cause

Material/Component Contamination

Status

Open, Classified

Product code

KNT

Quantity affected

72 kits

Distribution

US Nationwide distribution.

Date initiated

2026-04-30

Date posted

2026-06-05

Location

Alpharetta, GA

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