Open, ClassifiedPosted Feb 5, 2026·Initiated Jan 7, 2026
Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided)
Model/Catalog Number: KD-VC411Q-0720;
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.
Reason: Devices which did not undergo thermoforming could deform and lose performance.
Root cause: Process control
Recalling firm: Olympus Corporation of the AmericasType: Unit, Electrosurgical, Endoscopic (With Or Without Accessories)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 #Z-1278-2026
Open, ClassifiedPosted Feb 5, 2026·Initiated Jan 7, 2026
Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided)
Model/Catalog Number: KD-VC411Q-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.
Reason: Devices which did not undergo thermoforming could deform and lose performance.
Root cause: Process control
Recalling firm: Olympus Corporation of the AmericasType: Unit, Electrosurgical, Endoscopic (With Or Without Accessories)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 #Z-1279-2026
Open, ClassifiedPosted Feb 5, 2026·Initiated Jan 7, 2026
Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided)
Model/Catalog Number: KD-VC411Q-0320;
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.
Reason: Devices which did not undergo thermoforming could deform and lose performance.
Root cause: Process control
Recalling firm: Olympus Corporation of the AmericasType: Unit, Electrosurgical, Endoscopic (With Or Without Accessories)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 #Z-1280-2026
Open, ClassifiedPosted Feb 5, 2026·Initiated Jan 7, 2026
Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided)
Model/Catalog Number: KD-VC411Q-0330;
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.
Reason: Devices which did not undergo thermoforming could deform and lose performance.
Root cause: Process control
Recalling firm: Olympus Corporation of the AmericasType: Unit, Electrosurgical, Endoscopic (With Or Without Accessories)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 #Z-1281-2026
Open, ClassifiedPosted Feb 5, 2026·Initiated Jan 7, 2026
Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided)
Model/Catalog Number: KD-VC412Q-0215;
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.
Reason: Devices which did not undergo thermoforming could deform and lose performance.
Root cause: Process control
Recalling firm: Olympus Corporation of the AmericasType: Unit, Electrosurgical, Endoscopic (With Or Without Accessories)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 #Z-1282-2026
Open, ClassifiedPosted Feb 5, 2026·Initiated Jan 7, 2026
Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided)
Model/Catalog Number: KD-VC433Q-0720;
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.
Reason: Devices which did not undergo thermoforming could deform and lose performance.
Root cause: Process control
Recalling firm: Olympus Corporation of the AmericasType: Unit, Electrosurgical, Endoscopic (With Or Without Accessories)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 #Z-1283-2026
Open, ClassifiedPosted Feb 5, 2026·Initiated Jan 7, 2026
Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided)
Model/Catalog Number:KD-VC433Q-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.
Reason: Devices which did not undergo thermoforming could deform and lose performance.
Root cause: Process control
Recalling firm: Olympus Corporation of the AmericasType: Unit, Electrosurgical, Endoscopic (With Or Without Accessories)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 #Z-1284-2026
Open, ClassifiedPosted Feb 5, 2026·Initiated Jan 7, 2026
Product Name: Disposable Triple Lumen Sphincterotome
Model/Catalog Number: KD-411Q-0720
Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.
Reason: Devices which did not undergo thermoforming could deform and lose performance.
Root cause: Process control
Recalling firm: Olympus Corporation of the AmericasType: Unit, Electrosurgical, Endoscopic (With Or Without Accessories)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 #Z-1285-2026
Open, ClassifiedPosted Feb 5, 2026·Initiated Jan 7, 2026
Product Name: Disposable Triple Lumen Sphincterotome
Model/Catalog Number: KD-411Q-0730
Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.
Reason: Devices which did not undergo thermoforming could deform and lose performance.
Root cause: Process control
Recalling firm: Olympus Corporation of the AmericasType: Unit, Electrosurgical, Endoscopic (With Or Without Accessories)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 #Z-1286-2026
Open, ClassifiedPosted Feb 5, 2026·Initiated Jan 7, 2026
Product Name: Disposable Triple Lumen Sphincterotome
Model/Catalog Number: KD-401Q-0330
Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.
Reason: Devices which did not undergo thermoforming could deform and lose performance.
Root cause: Process control
Recalling firm: Olympus Corporation of the AmericasType: Unit, Electrosurgical, Endoscopic (With Or Without Accessories)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 #Z-1287-2026
Open, ClassifiedPosted Feb 5, 2026·Initiated Jan 7, 2026
Product Name: Disposable Triple Lumen Sphincterotome
Model/Catalog Number: KD-401Q-0720
Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.
Reason: Devices which did not undergo thermoforming could deform and lose performance.
Root cause: Process control
Recalling firm: Olympus Corporation of the AmericasType: Unit, Electrosurgical, Endoscopic (With Or Without Accessories)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 #Z-1288-2026
Open, ClassifiedPosted Feb 5, 2026·Initiated Jan 7, 2026
Product Name: Disposable Triple Lumen Sphincterotome
Model/Catalog Number: KD-401Q-0730
Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.
Reason: Devices which did not undergo thermoforming could deform and lose performance.
Root cause: Process control
Recalling firm: Olympus Corporation of the AmericasType: Unit, Electrosurgical, Endoscopic (With Or Without Accessories)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 #Z-1289-2026
Open, ClassifiedPosted Feb 5, 2026·Initiated Jan 7, 2026
Product Name: Single Use 3-Lumen Sphincterotome V
Model/Catalog Number: KD-V411M-1520
Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.
Reason: Devices which did not undergo thermoforming could deform and lose performance.
Root cause: Process control
Recalling firm: Olympus Corporation of the AmericasType: Unit, Electrosurgical, Endoscopic (With Or Without Accessories)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 #Z-1290-2026
Open, ClassifiedPosted Feb 5, 2026·Initiated Jan 7, 2026
Product Name: Single Use 3-Lumen Sphincterotome V
Model/Catalog Number: KD-V411M-1530
Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.
Reason: Devices which did not undergo thermoforming could deform and lose performance.
Root cause: Process control
Recalling firm: Olympus Corporation of the AmericasType: Unit, Electrosurgical, Endoscopic (With Or Without Accessories)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 #Z-1291-2026
Open, ClassifiedPosted Feb 5, 2026·Initiated Jan 7, 2026
Product Name: Single Use 3-Lumen Sphincterotome V
Model/Catalog Number: KD-V411M-3030
Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.
Reason: Devices which did not undergo thermoforming could deform and lose performance.
Root cause: Process control
Recalling firm: Olympus Corporation of the AmericasType: Unit, Electrosurgical, Endoscopic (With Or Without Accessories)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 #Z-1292-2026
Open, ClassifiedPosted Feb 5, 2026·Initiated Jan 7, 2026
Brand Name: Disposable Triple Lumen Sphincterotome
Product Name: Disposable Triple Lumen Sphincterotome
Model/Catalog Number: KD-401Q-0320
Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.
Reason: Devices which did not undergo thermoforming could deform and lose performance.
Root cause: Process control
Recalling firm: Olympus Corporation of the AmericasType: Unit, Electrosurgical, Endoscopic (With Or Without Accessories)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 #Z-1293-2026
Open, ClassifiedPosted Feb 5, 2026·Initiated Jan 7, 2026
Product Name: Disposable Triple Lumen Sphincterotome
Model/Catalog Number: KD-401Q-0725
Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.
Reason: Devices which did not undergo thermoforming could deform and lose performance.
Root cause: Process control
Recalling firm: Olympus Corporation of the AmericasType: Unit, Electrosurgical, Endoscopic (With Or Without Accessories)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 #Z-1294-2026
Open, ClassifiedPosted Feb 5, 2026·Initiated Jan 7, 2026
Product Name: Single Use 3-Lumen Sphincterotome V
Model/Catalog Number: KD-V411M-3020
Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.
Reason: Devices which did not undergo thermoforming could deform and lose performance.
Root cause: Process control
Recalling firm: Olympus Corporation of the AmericasType: Unit, Electrosurgical, Endoscopic (With Or Without Accessories)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 #Z-1295-2026
Open, ClassifiedPosted Feb 5, 2026·Initiated Jan 7, 2026
Product Name: Single Use 3-Lumen Sphincterotome V
Model/Catalog Number: KD-V411M-3025
Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.
Reason: Devices which did not undergo thermoforming could deform and lose performance.
Root cause: Process control
Recalling firm: Olympus Corporation of the AmericasType: Unit, Electrosurgical, Endoscopic (With Or Without Accessories)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 #Z-1296-2026
Open, ClassifiedPosted Feb 5, 2026·Initiated Jan 7, 2026
Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided)
Model/Catalog Number: KD-VC411Q-0725;
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.
Reason: Devices which did not undergo thermoforming could deform and lose performance.
Root cause: Process control
Recalling firm: Olympus Corporation of the AmericasType: Unit, Electrosurgical, Endoscopic (With Or Without Accessories)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 #Z-1297-2026