Agency classClass IIOur severity:High FDA (Devices)·Z-2348-2026·Announced 2026-06-17

MIC Safety 20 Fr push OTW PEG kits contain recalled lidocaine

MIC Safety PEG Kits with ENFit Connectors, 20 Fr PUSH OTW, catalog number 8170-20, are being recalled because they contain lidocaine hydrochloride injection subject to a supplier recall.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II recall where an injectable drug with unresolved quality issues was packed into sterile kits, a risk of harm with no injuries reported.

Plain-English summary

The MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit Connectors, 20 Fr PUSH OTW, model/catalog number 8170-20, is being recalled. The action covers 1,615 kits.

The stated reason is that lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, was included in sterile kits and sets. The FDA classified the action as Class II.

Affected product is UDI-DI 10350770007820, lot numbers 30371324, 30374833, 30384889 and 80403350. Distribution was nationwide in the United States. The kits are supplied to healthcare facilities rather than sold to consumers.

Facilities should identify affected stock using the catalog number, UDI-DI and lot numbers above, quarantine it, and follow the instructions issued by the manufacturer.

The recalled product

Product: Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit Connectors 20 Fr PUSH OTW Model/Catalog Number: 8170-20
Manufacturer: Avanos Medical, Inc.
Category: Medical Device — Gastrostomy kit
Hazard: contained-drug-recall
lidocaine
supplier-recall
class-ii
Affected units: 1,615

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (5)

UDI-DI 10350770007820
Lot Numbers 30371324
30374833
30384889
80403350

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 20 recalled by Avanos Medical, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 20 products in this recall →

Same manufacturer · Avanos Medical, Inc.

See all →

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Same hazard · contained drug recall