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Use caution Medical device recall · FDA · Published October 8, 2019

Avanos CORFLO PEG Kit with ENFit Connector: Connector Fails to Pass Over Guidewire

Avanos Medical recalls 2 units of CORFLO PEG kits with ENFit connectors due to risk of guidewire not passing through the connector, potentially causing complications during medical procedures.

🇺🇸 FDA recall #Z-0371-2020Medical deviceAvanos Medical ›
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Recalling firmAvanos Medical, Inc.5405 Windward Pkwy · Alpharetta, GA 30004-3894
✎ GovInfoNow plain-language explainer

Avanos Medical recalls two specific units of CORFLO PEG kits with ENFit connectors because the connector may not allow the guidewire to pass through properly. This could lead to complications during medical procedures if the device is used incorrectly. Read more at govinfonow.com/recall/66867-avanos-corflo-peg-kit-with-enfit-connector-connector-fails-to.

Source Summary by GovInfoNow · govinfonow.com/recall/66867-avanos-corflo-peg-kit-with-enfit-connector-connector-fails-to · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0371-2020

Cite this page

“Avanos CORFLO PEG Kit with ENFit Connector: Connector Fails to Pass Over Guidewire.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/66867-avanos-corflo-peg-kit-with-enfit-connector-connector-fails-to. Based on FDA recall #Z-0371-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0371-2020%22&limit=1).

The FDA announced on 2019-10-08 that Avanos Medical, Inc. voluntarily recalled CORFLO* Percutaneous Endoscopic Gastrostomy (PEG) Kits labeled with ENFit connectors due to a connector hazard. The agency classified the recall as Class II.

How to tell if you have it

  • Brand: Avanos Medical (may be branded as Halyard Health)
  • Product: CORFLO* PEG Kit with ENFit Connector
  • Catalog Number: 50-4016E1, Lot Numbers: 0203137961, 0203172166
  • Catalog Number: 50-4020E1, Lot Number: 0203069043

The hazard

According to the FDA, the connector piece to the PEG tube does not pass over the guidewire. The recall involved 104 cases (208 units) distributed to CT, IN, MD, NJ, PA, VA, and Great Britain.

Context

GovInfoNow's records show Avanos Medical, Inc. has 18 other recalls on record since 2019-11-05. Other recent recalls of similar products include Avanos Medical PEG Kit with ENFit Connectors: Lidocaine Quality Issue Recall (2026-04-30), Ballard Closed Suction Catheters Recall (2025-03-19), and Avanos MIC-KEY Gastric-Jejunal Feeding Tube Kit Recall (2024-05-31). Other recent recalls of similar products include Medline ENFIT G-Tube Connectors May Leak; Recalled for Safety (2026-02-13), Medline ENFIT G-TUBE Connector Recall: Leakage Risk from Poor Seal (2026-02-13), and Medela ENFit ExSet Strl 60 2.0ml PV 1ct EN: Incompatible Connectors Risk (2026-06-05).

How to tell if you have this one

Check for the CORFLO PEG kit labeled with ENFit connector. The specific catalog numbers are 50-4016E1 (lot numbers 0203137961, 0203172166) and 50-4020E1 (lot number 0203069043).

  • Brand
    Avanos Medical
  • Category
    Medical device
FDA recall event · 2 products

All 2 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

  • Classification
    Class II
  • Status
    Terminated
  • Distribution
    Distribution to CT, IN, MD, NJ, PA, VA. International distribution to Great Britain.
Recall numberProduct, codes & lots
Z-0370-2020CORFLO* Percutaneous Endoscopic Gastrostomy (PEG) Kit, Labeled as CORFLO* PEG Kit. 2 units per case The devices could be branded as Halyard Health.; Catalog Number: 30-4020 (Lot Numbers:0203145253, 0203081127); Catalog Number: 30-4320 (Lot Numbers: 0002994173, 0202974008, 0202907370, 0203201718, 0203241065)
Z-0371-2020CORFLO* 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.; Catalog Number: 50-4016E1 (Lot Numbers:0203137961, 0203172166); Catalog Number: 50-4020E1 (Lot Number: 0203069043)
Based on the official FDA remedy

What to do — step by step

  1. Check Product Details

    Verify the catalog number and lot number on the kit to confirm if it is recalled.

Where it went and when

Where it was distributed

Distributed in 6 states, and outside the U.S.

Alaska: not listedAKMaine: not listedMEVermont: not listedVTNew Hampshire: not listedNHWashington: not listedWAIdaho: not listedIDMontana: not listedMTNorth Dakota: not listedNDMinnesota: not listedMNIllinois: not listedILWisconsin: not listedWIMichigan: not listedMINew York: not listedNYRhode Island: not listedRIMassachusetts: not listedMAOregon: not listedORNevada: not listedNVWyoming: not listedWYSouth Dakota: not listedSDIowa: not listedIAIndiana: yesINOhio: not listedOHPennsylvania: yesPANew Jersey: yesNJConnecticut: yesCTCalifornia: not listedCAUtah: not listedUTColorado: not listedCONebraska: not listedNEMissouri: not listedMOKentucky: not listedKYWest Virginia: not listedWVVirginia: yesVAMaryland: yesMDDelaware: not listedDEArizona: not listedAZNew Mexico: not listedNMKansas: not listedKSArkansas: not listedARTennessee: not listedTNNorth Carolina: not listedNCSouth Carolina: not listedSCDistrict of Columbia: not listedDCOklahoma: not listedOKLouisiana: not listedLAMississippi: not listedMSAlabama: not listedALGeorgia: not listedGAHawaii: not listedHITexas: not listedTXFlorida: not listedFL

FDA distribution: “Distribution to CT, IN, MD, NJ, PA, VA. International distribution to Great Britain.” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Connecticut, Indiana, Maryland, New Jersey, Pennsylvania, Virginia.

Recall timeline

FDA terminated this recall 2.4 years after the firm started it.

1. Firm started the recall: Oct 8, 201912. FDA classified it Class II: Nov 14, 201923. Published in FDA’s Enforcement Report: Nov 20, 201934. FDA terminated the recall: Mar 16, 2022420192022
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report
  4. FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #Z-0371-2020 (October 8, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0371-2020 to see it in context.
  • Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA