CLASS II Device recall · Reported 16 Feb 2022 · FDA Enforcement Report

MIC* Percutaneous Endoscopic Gastrostomy PEG Kit recalled

Avanos Medical is recalling MIC* Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit Connectors --PULL, distributed nationwide in the US. The recall was initiated on 22 Dec 2021 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codes1) Code 8160-20, Lot 30135103 2) Code 8640-20, Lot 30132544

Quantity recalled692 units

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-0566-2022
FDA event ID: 89290
Recalling firm: Avanos Medical, Alpharetta, GA
Classification: Class II
Status: Terminated
Recall initiated: 22 Dec 2021
FDA classified: 7 Feb 2022
Reported: 16 Feb 2022
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Other Reasons
Device type: Surgical Instruments

Timeline

22 Dec 2021	Recall initiated by company
7 Feb 2022	Classified by FDA	+47 days
16 Feb 2022	Published in enforcement report	+9 days

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

Reason for recall

The External Retention Bolster contained in the kit may be a larger diameter than the tube.

Product as listed by the FDA

MIC* Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit Connectors - 20 Fr-PULL

Where it was distributed

Worldwide distribution - US Nationwide and the countries of Canada and Chile.

Nationwide

Questions about this recall

Why was it recalled?

The External Retention Bolster contained in the kit may be a larger diameter than the tube.

Which lots are affected?

1) Code 8160-20, Lot 30135103 2) Code 8640-20, Lot 30132544

Where was it sold?

Worldwide distribution - US Nationwide and the countries of Canada and Chile.

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

Other products in this recall event

1 other product · FDA event 89290

Reported	Class	Recall	Company	Reason	Where
16 Feb 2022	CLASS II	MIC* Percutaneous Endoscopic Gastrostomy PEG Kit --PULL recalled	Avanos Medical	Other	Nationwide

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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