Recall Z-1274-2026
Olympus Corporation of the Americas · initiated January 7, 2026
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-0730; Software Version: N/A Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.
Codes / lots: Model/Catalog Number: KD-V411M-0730; Material REF: (1) N1089810, (2) N5411530; UDI-DI: (1) 04953170380594, (2) 04953170380594; All Lots with a valid expiration date
Reason for recall
Devices which did not undergo thermoforming could deform and lose performance.
FDA-determined cause: Process control
Action taken
On or around January 7, 2026, URGENT: MEDICAL DEVICE REMOVAL letters were sent to customers. Actions to be taken: the following actions: 1. Examine your inventory and quarantine any identified devices immediately. 2. Immediately cease usage of any affected product in your inventory. 3. Please contact Customer Service at 1-800-848-9024, option 2, to obtain a Return Material Authorization. Olympus will arrange for the return of your device to Olympus. Olympus will issue a credit to your facility upon receipt of your affected product. 4. Olympus requests that you acknowledge receipt of this letter through our recall web portal: a. Go to https://olympusamerica.com/recall b. Enter the recall number: "0487 c. Complete the form as instructed. 5. If you have further distributed it, please forward this notice to other users who may have the affected products. Olympus requests you to report any complaints to our Technical Assistance Center (TAC) at 1-800-848-9024, option 1, and the FDA. Adverse events experienced with the use of this product may also be reported to the FDA s MedWatch Adverse Event Reporting program either online, by regular mail, or by fax. Olympus fully appreciates your prompt cooperation in addressing this situation. If you require additional information, please do not hesitate to contact me at Cynthia.Ow@olympus.com or by phone at (647) 999-3203.
Details
- Recall number
- Z-1274-2026
- Initiated
- January 7, 2026
- Posted by FDA
- February 5, 2026
- Product code
- KNS – Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
- Quantity
- 86303 units (1803 US, 84500 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.
- Recalling firm
- Olympus Corporation of the Americas, Center Valley, PA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1268-2026 Class II | Brand Name: CleverCut Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog…Devices which did not undergo thermoforming could deform and lose performance. | 01/07/2026Open, Classified |
| Z-1269-2026 Class II | Product Name: Single Use Sphincterotome V (Distal Wire guided) Model/Catalog Number:…Devices which did not undergo thermoforming could deform and lose performance. | 01/07/2026Open, Classified |
| Z-1270-2026 Class II | Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-431Q-0720…Devices which did not undergo thermoforming could deform and lose performance. | 01/07/2026Open, Classified |
| Z-1271-2026 Class II | Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-0330…Devices which did not undergo thermoforming could deform and lose performance. | 01/07/2026Open, Classified |
| Z-1272-2026 Class II | Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-0720…Devices which did not undergo thermoforming could deform and lose performance. | 01/07/2026Open, Classified |
| Z-1273-2026 Class II | Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-0725…Devices which did not undergo thermoforming could deform and lose performance. | 01/07/2026Open, Classified |
| Z-1275-2026 Class II | Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V431M-0720…Devices which did not undergo thermoforming could deform and lose performance. | 01/07/2026Open, Classified |
| Z-1276-2026 Class II | Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V431M-0730…Devices which did not undergo thermoforming could deform and lose performance. | 01/07/2026Open, Classified |
| Z-1277-2026 Class II | Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog…Devices which did not undergo thermoforming could deform and lose performance. | 01/07/2026Open, Classified |
| Z-1278-2026 Class II | Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog…Devices which did not undergo thermoforming could deform and lose performance. | 01/07/2026Open, Classified |
| Z-1279-2026 Class II | Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog…Devices which did not undergo thermoforming could deform and lose performance. | 01/07/2026Open, Classified |
| Z-1280-2026 Class II | Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog…Devices which did not undergo thermoforming could deform and lose performance. | 01/07/2026Open, Classified |
| Z-1281-2026 Class II | Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog…Devices which did not undergo thermoforming could deform and lose performance. | 01/07/2026Open, Classified |
| Z-1282-2026 Class II | Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog…Devices which did not undergo thermoforming could deform and lose performance. | 01/07/2026Open, Classified |
| Z-1283-2026 Class II | Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog…Devices which did not undergo thermoforming could deform and lose performance. | 01/07/2026Open, Classified |
| Z-1284-2026 Class II | Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog…Devices which did not undergo thermoforming could deform and lose performance. | 01/07/2026Open, Classified |
| Z-1285-2026 Class II | Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-411Q-0720…Devices which did not undergo thermoforming could deform and lose performance. | 01/07/2026Open, Classified |
| Z-1286-2026 Class II | Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-411Q-0730…Devices which did not undergo thermoforming could deform and lose performance. | 01/07/2026Open, Classified |
| Z-1287-2026 Class II | Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0330…Devices which did not undergo thermoforming could deform and lose performance. | 01/07/2026Open, Classified |
| Z-1288-2026 Class II | Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0720…Devices which did not undergo thermoforming could deform and lose performance. | 01/07/2026Open, Classified |
| Z-1289-2026 Class II | Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0730…Devices which did not undergo thermoforming could deform and lose performance. | 01/07/2026Open, Classified |
| Z-1290-2026 Class II | Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-1520…Devices which did not undergo thermoforming could deform and lose performance. | 01/07/2026Open, Classified |
| Z-1291-2026 Class II | Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-1530…Devices which did not undergo thermoforming could deform and lose performance. | 01/07/2026Open, Classified |
| Z-1292-2026 Class II | Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-3030…Devices which did not undergo thermoforming could deform and lose performance. | 01/07/2026Open, Classified |
| Z-1293-2026 Class II | Brand Name: Disposable Triple Lumen Sphincterotome Product Name: Disposable Triple Lumen…Devices which did not undergo thermoforming could deform and lose performance. | 01/07/2026Open, Classified |
| Z-1294-2026 Class II | Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0725…Devices which did not undergo thermoforming could deform and lose performance. | 01/07/2026Open, Classified |
| Z-1295-2026 Class II | Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-3020…Devices which did not undergo thermoforming could deform and lose performance. | 01/07/2026Open, Classified |
| Z-1296-2026 Class II | Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-3025…Devices which did not undergo thermoforming could deform and lose performance. | 01/07/2026Open, Classified |
| Z-1297-2026 Class II | Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog…Devices which did not undergo thermoforming could deform and lose performance. | 01/07/2026Open, Classified |