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Product Name: MIC Safety Percutaneous Endoscopic… recallZ-2345-2026 · Avanos Medical, Inc. · initiated Apr 30, 2026

Class II Open, Classified All recalls posted in June 2026

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Avanos Medical, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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

FDA root cause category: Material/Component Contamination

What the company is doing

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.

Recall details

Recall number
Z-2345-2026
Recall class
Class II
Status
Open, Classified
Initiated by the company
Apr 30, 2026
Posted by the FDA
Jun 5, 2026
Recalling firm
Avanos Medical, Inc.
Quantity
3,184 kits
Product code
KNT
FDA submissions
K924065
Distribution
US Nationwide distribution.

Product description

Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit 20 Fr PULL Model/Catalog Number: 7180-20

Code information (models, lots, serial numbers)

UDI-DI 10350770007783, Lot Numbers 30371313, 30371314, 30373295, 30373296, 30374832, 30378735, 80403340

Other devices under the same FDA submission

34 devices cleared under K924065 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 98907).

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page