# FDA recall Z-2038-2024

> **Covidien, LLC** · Class II · device recall initiated 2024-04-25.

## Product

EsoFLIP,  30mm BALLOON DILATION CATHETER, REF ES-330,  Rx Only

## Reason for recall

Due to saline conductivity issues, their is a potential that dilation catheters may provide inaccurate esophageal diameter measurements  that may lead to various harms.

## 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, Australia, Austria, Bahrain, Belgium, Canada, 	Denmark, Germany, Ireland, Italy, Kuwait, New Zealand, Norway, Portugal, Qatar, South Africa, Switzerland, United Arab Emirates.

## Key facts

- **Recall number:** Z-2038-2024
- **Recalling firm:** Covidien, LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-04-25
- **Report date:** 2024-06-19

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Santa Clara, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2038-2024

## Citation

> AI Analytics. FDA recall Z-2038-2024. Retrieved 2026-07-30 from https://api.ai-analytics.org/recall/Z-2038-2024. Source: US FDA. Licensed CC0.

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