CORFLO Percutaneous Endoscopic Gastrostomy (PEG)Kit
Medical device recall Z-1822-2020. Published in FDA’s Enforcement Report on May 6, 2020.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on May 6, 2020. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word, and 24 states named
- 1766 how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“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.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
The CORFLO PEG tube may become blocked at the center of the adapter (occluded) potentially causing a procedure to delayed or aborted.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
CORFLO Percutaneous Endoscopic Gastrostomy (PEG)Kit
1766, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
CORFLO* PEG Kit: Product Code: 30-6012 with lot# 0203214820, 0203251844 Product Code: 30-6016 with lot# 0002997221, 0020006332 Product Code: 30-6020 with lot# 0002994174, 0203251786 CORFLO* PEG Kit with ENFit¿ Connector Product Code:…
Every code shown here, 1,019 characters
CORFLO* PEG Kit: Product Code: 30-6012 with lot# 0203214820, 0203251844 Product Code: 30-6016 with lot# 0002997221, 0020006332 Product Code: 30-6020 with lot# 0002994174, 0203251786 CORFLO* PEG Kit with ENFit¿ Connector Product Code: 50-4016E1 with lot#: 0020008354, 0020008547, 0020008666 Product Code: 50-4020E1 with lot#: 0020008544 Product Code: 50-6012 with lot#: 0203214902, 0203245678 Product Code: 50-6012E1 with lot#: 0203251785, 0020003356 Product Code: 50-6012E2 with lot#: 0002997217, 0203239802, 2001368 Product Code: 50-6016E1 with lot#: 0002994170, 0203241062, 0203214905, 0203245676, 0203251843, 0020003029, 0203261078 Product Code: 50-6016E2 with lot#: 0203261079, 20012261, 0203239803, 0002994171, 20011367 Product Code: 50-6020 with lot#: 0203214903 Product Code: 50-6020E2 with lot#: 0203214901, 0203239804, 0203248168, 20011369 CORFLO* Safety PEG Kit with ENFit¿ Connector Product Code: 50-6316 with lot#: 0203241064 CORFLO* PEG Kit with ENFit¿ Connector Product Code: 50-6520 with lot#: 0203241063
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
Worldwide and US Nationwide Distribution: AZ, CA, CT, FL, GA, IA, ID, IL, LA, MO, MN, MD, NY, NM, NV, NJ, OR, OK, OH, RI, TN, TX, WA, WI, ***Foreign: Distributed to Australia, Belgium, Canada, France, Germany, Ireland, Italy, Netherlands, Romania, United Arab Emirates, United Kingdom
The states and territories these words name
24 states and territories.
Every one of them
- Arizona
- California
- Connecticut
- Florida
- Georgia
- Iowa
- Idaho
- Illinois
- Louisiana
- Maryland
- Minnesota
- Missouri
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Rhode Island
- Tennessee
- Texas
- Washington
- Wisconsin
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
The words say it went outside the United States too.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Terminated, in FDA’s file.
“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”
openFDA, on “Terminated”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Mar 16, 2020.
- FDA classified it on Apr 29, 2020.
- FDA’s Enforcement Report published it on May 6, 2020.
- FDA terminated it on Aug 31, 2023.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Avanos Medical, Inc., of Alpharetta, GA.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
-
U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.