Covidien, LLC EsoFLIP, 30mm BALLOON DILATION CATHETER, REF ES-330, Rx Only Recall
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
EsoFLIP, 30mm BALLOON DILATION CATHETER, REF ES-330, Rx Only
Brand
Covidien, LLC
Lot Codes / Batch Numbers
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
Products Sold
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
Covidien, LLC is recalling EsoFLIP, 30mm BALLOON DILATION CATHETER, REF ES-330, Rx Only due to Due to saline conductivity issues, their is a potential that dilation catheters may provide inaccurate esophageal diameter measurements that may lead. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Due to saline conductivity issues, their is a potential that dilation catheters may provide inaccurate esophageal diameter measurements that may lead to various harms.
Recommended Action
Per FDA guidance
On April 25, 2024, Medtronic issued a "Urgent: Medical Device Recall" Notification. Medtronic ask consignees to take the following actions: 1. Immediately identify and quarantine all unused EsoflipTM dilation catheter 30mm Model # ES-330 from the affected lot numbers. 2. Return all unused affected product(s) in your inventory to: Medtronic Attn: Field Returns Dept. 195 McDermott Road North Haven, CT 06473 USA 3. Credit for returned catheters that are part of this recall will be applied upon receipt. 4. Please complete and return the enclosed Customer Confirmation Form, even if you have no product to return. 5. Product purchased directly from Medtronic, please contact 1-800-448-3644 (option 2 followed by option 2 again) for Return Goods Authorization (RGA). Your local Medtronic Representative can assist you as necessary in initiating the return of this product. 6. If purchased from a distributor, contact your distributor directly to arrange for the return of the product back to your distributor. 7. This notice needs to be passed on to all those who need to be aware within your organization or to any organization where the potentially affected devices have been transferred. 8. Please transfer this notice to other organizations on which this action has an impact. 9. Please maintain a copy of this notice in your records.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026