CLASS II ONGOING Device recall · Reported 17 Jun 2026 · FDA Enforcement Report

Corflo* Safety PEG Kit recalled by Avanos Medical

Avanos Medical is recalling Corflo* Safety PEG Kit, distributed nationwide in the US. The recall was initiated on 30 Apr 2026 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUDI-DI 10350770007585, Lot Numbers 30365226 and 30382750

Quantity recalled231 kits

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2333-2026
FDA event ID: 98907
Recalling firm: Avanos Medical, Alpharetta, GA
Classification: Class II
Status: Ongoing
Recall initiated: 30 Apr 2026
FDA classified: 5 Jun 2026
Reported: 17 Jun 2026
Type: Voluntary: Firm initiated
Customers notified by: N/A
Reason category: Sterility
Device type: Other Medical Devices

Timeline

30 Apr 2026	Recall initiated by company
5 Jun 2026	Classified by FDA	+36 days
17 Jun 2026	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

Brand Name: CORFLO Product Name: CORFLO* Safety PEG Kit Model/Catalog Number: 30-4320

Where it was distributed

US Nationwide distribution.

Nationwide

Questions about this recall

Is Corflo* Safety PEG Kit recalled?

Yes. Avanos Medical recalled Corflo* Safety PEG Kit on 30 Apr 2026. The recall is Class II and its status is Ongoing. Recall number Z-2333-2026.

Why was it recalled?

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

Which lots are affected?

UDI-DI 10350770007585, Lot Numbers 30365226 and 30382750

Where was it sold?

US Nationwide distribution.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Avanos Medical

All 57

Reported	Class	Recall	Company	Reason	Where
17 Jun 2026Device	CLASS II	MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit PUSH OTW recalled	Avanos Medical	Sterility	Nationwide
17 Jun 2026Device	CLASS II	MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit recalled	Avanos Medical	Sterility	Nationwide
17 Jun 2026Device	CLASS II	MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit PULL recalled	Avanos Medical	Sterility	Nationwide
17 Jun 2026Device	CLASS II	MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit recalled	Avanos Medical	Sterility	Nationwide
17 Jun 2026Device	CLASS II	Corflo Safety PEG Kit with ENFit Connector recalled by Avanos Medical	Avanos Medical	Sterility	Nationwide

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