Z-2038-2024 Class II Ongoing
FDA device recall Z-2038-2024 was initiated by Covidien, LLC on Apr 25, 2024 and is designated Class II. 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. The recall status is ongoing.
Recall Details
- Product Type
- Devices
- Report Date
- Jun 19, 2024
- Initiation Date
- Apr 25, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
Product Description
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 Pattern
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.
Code Information
GTIN Number: 10884521809451/ Lot: 22K0854JZ, 23H0552JZ; GTIN Number: 20884521809458/ Lot: 22E0781JZ, 22E0997JZ, 22I0422JZ, 22I0424JZ, 22I0425JZ, 22J1362JZ,22K0743JZ, 22K0744JZ, 22K0745JZ,22K0746JZ, 22K0854JZ, 23A0109JZ,23A0111JZ, 23A1200JZ, 23A1201JZ,23A1202JZ, 23C0144JZ, 23C0668JZ, 23C0669JZ, 23D0777JZ, 23D0778JZ,23H0047JZ, 23H0552JZ, 23H0553JZ,23H0554JZ, 23H0623JZ, 23H0624JZ,23L0331JZ, 23L0338JZ, 23L0339JZ,24A0014JZ, 24A0015JZ, 24B0392JZ
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2038-2024
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026