CLASS II Device recall · Reported 20 Nov 2019 · FDA Enforcement Report

Corflo* Percutaneous Endoscopic Gastrostomy (Peg) Kit recalled

Avanos Medical is recalling Corflo* Percutaneous Endoscopic Gastrostomy (Peg) Kit, Labeled as Corflo* Peg Kit with, distributed in Connecticut, Indiana, Maryland, New Jersey, Pennsylvania, Virginia. The recall was initiated on 8 Oct 2019 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesCatalog Number: 50-4016E1 (Lot Numbers:0203137961, 0203172166); Catalog Number: 50-4020E1 (Lot Number: 0203069043)

Quantity recalled104 cases (208 units) total

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-0371-2020
FDA event ID: 84021
Recalling firm: Avanos Medical, Alpharetta, GA
Classification: Class II
Status: Terminated
Recall initiated: 8 Oct 2019
FDA classified: 14 Nov 2019
Reported: 20 Nov 2019
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Surgical Instruments

Timeline

8 Oct 2019	Recall initiated by company
14 Nov 2019	Classified by FDA	+37 days
20 Nov 2019	Published in enforcement report	+6 days

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

Reason for recall

The connector piece to the PEG tube does not pass over the guidewire.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

CORFLO* Percutaneous Endoscopic Gastrostomy (PEG) Kit, Labeled as CORFLO* PEG Kit with ENFit Connector. 2 units per case The devices could be branded as Halyard Health.

Where it was distributed

Distribution to CT, IN, MD, NJ, PA, VA. International distribution to Great Britain.

Connecticut Indiana Maryland New Jersey Pennsylvania Virginia

Questions about this recall

Why was it recalled?

The connector piece to the PEG tube does not pass over the guidewire.

Which lots are affected?

Catalog Number: 50-4016E1 (Lot Numbers:0203137961, 0203172166); Catalog Number: 50-4020E1 (Lot Number: 0203069043)

Where was it sold?

Distribution to CT, IN, MD, NJ, PA, VA. International distribution to Great Britain.

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 84021

Reported	Class	Recall	Company	Reason	Where
20 Nov 2019	CLASS II	Corflo* Percutaneous Endoscopic Gastrostomy (Peg) Kit recalled	Avanos Medical	Device Malfunction	6 states

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

Other Surgical Instruments recalls

All 3,809

Reported	Class	Recall	Company	Reason	Where
9 Sep 2026Device	CLASS II	Medline Convenience Kits: IV Start KIT recalled by Medline Industries	Medline Industries	Sterility	Nationwide
9 Sep 2026Device	CLASS II	Medline Convenience Kits containing BD ChloraPrep Clear recalled	Medline Industries	Packaging Defects	Nationwide
2 Sep 2026Device	CLASS II	Medline convenience kits labeled as: Open Heart Pack, Medline Kit recalled	Medline Industries	Other	Nationwide
2 Sep 2026Device	CLASS II	Medline convenience kits labeled as: GYN Robotic CDS, Medline Kit recalled	Medline Industries	Other	Nationwide
2 Sep 2026Device	CLASS II	Linvatec Genesys CrossFT Suture Anchor with Disposable Driver recalled	ConMed	Other	Nationwide