Covidien recalls EsoFLIP 30mm balloon dilation catheters (REF ES-330) due to potential inaccurate esophageal diameter measurements that could lead to harmful outcomes. Affected units include specific lots from 2022-2024.
Due to saline conductivity issues, their is a potential that dilation catheters may provide inaccurate esophageal diameter measurements that may lead to various harms.
Take action
Contact the company
📍Recalling firmCovidien, LLC3062 Bunker Hill Ln · Santa Clara, CA 95054-1105
“Covidien EsoFLIP 30mm Balloon Catheter Recall: Inaccurate Esophageal Measurements Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/55303-covidien-esoflip-30mm-balloon-catheter-recall-inaccurate-esophageal-measurements-risk. Based on FDA recall #Z-2038-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2038-2024%22&limit=1).
The FDA announced on April 25, 2024, that Covidien LLC is recalling EsoFLIP 30mm balloon dilation catheters due to saline conductivity issues that may cause inaccurate esophageal diameter measurements. Owners should contact the company for a remedy.
Due to saline conductivity issues, the dilation catheters may provide inaccurate esophageal diameter measurements that may lead to various harms.
Context
GovInfoNow's records show Covidien LLC has 52 other recalls on record since 2017-08-07. Recent similar product recalls include the Diversatek Viper 3-Stage Balloon Dilator Recall (2026-03-18) and the Olympus Nephro-EZDilate Catheter Kit (2025-10-17).
How to tell if you have this one
Check for the product name 'EsoFLIP 30mm Balloon Dilation Catheter' with reference number ES-330. Affected units include specific lots listed in the recall notice, such as 22K0854JZ through 24B0392JZ.
Look for the product name 'EsoFLIP 30mm Balloon Dilation Catheter' with reference number ES-330 on the packaging or label.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 34 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “Worldwide - US Nationwide distribution including in the states of AK, AL, AZ, CA, CO, CT, DC, FL, GA, IA, IL, KS, KY, LA, MA, MD, MI, MN, MO, NC, NE, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI and the countries of Argentina,…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alabama, Alaska, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Illinois, Iowa, Kansas, Kentucky, Louisiana, Maryland, Massachusetts, Michigan, Minnesota, Missouri, Nebraska, Nevada, New Jersey, New York, North Carolina, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin.
Recall timeline
FDA published this recall 55 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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-2038-2024 (April 25, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2038-2024 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.