EsoFLIP — Class II medical device recall Z-2038-2024
Ongoing recall by Covidien, LLC, reported 2024-06-19, distributed nationwide. Due to saline conductivity issues, their is a potential that dilation catheters may provide inaccurate esophag
| Recall number | Z-2038-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Covidien, LLC, Santa Clara, CA, United States |
| Recall initiated | 2024-04-25 |
| Classified | 2024-06-07 |
| Reported by FDA | 2024-06-19 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BE, BH, CA, CH, DE, DK, IE, IT, KW, NO, NZ, PT, QA, ZA |
| UPC / GTIN / UDI-DI | 10884521809451, 20884521809458 |
| Lot numbers | 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 |
| Model numbers | ES-330 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2038-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.