Brand Name: CleverCut Product Name: Single Use 3-Lumen recall
Brand Name: CleverCut Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-0320; Software Version: N/A Product…
Why was Brand Name: CleverCut Product Name: Single Use 3-Lumen recalled?
Devices which did not undergo thermoforming could deform and lose performance.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Model/Catalog Number: KD-V411M-0320; Material REF: (1) N1089430, (2) N1089410, (3) N5411130; UDI-DI: (1) 04953170183973, (2) 04953170466274, (3) 04953170380556; All Lots with a valid expiration date
- Product
- Brand Name: CleverCut Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-0320; Software Version: N/A Product…
- Recalling firm
- Olympus Corporation of the Americas
- Quantity
- 72023 units (3920 US, 68103 OUS)
- Distribution
- Worldwide - US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, DC, DE, FL, GA, GU, HI, IA, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY and International: TBD.
- Recall date
- February 11, 2026
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)