Open, ClassifiedPosted Feb 6, 2026·Initiated Dec 22, 2025
Reprocessed St. Jude Supreme and Response Diagnostic Electrophysiology Catheters:
St. Jude Medical Supreme Diagnostic Electrophysiology Catheter 4 Elec. 2-5-2mm
401211RH
401222RH
401223RH
401226RH
401227RH
401260RH
401261RH
401306RH
401309RH
401312RH
401430RH
401433RH
401435RH
401441RH
401442RH
401443RH
401448RH
401449RH
401450RH
401451RH
401474RH
401860RH
401877RH
401878RH
401890RH
401891RH
401994RH;
St. Jude Medical Supreme Diagnostic Electrophysiology Catheter 4 Elec. 5-5-5mm
402012RH;
St. Jude Medical Supreme Diagnostic Electrophysiology Catheter 4 Elec. 5mm
402004RH;
St. Jude Medical Supreme Diagnostic Electrophysiology Catheter 6 Elec. 2-5-2mm
402010RH;
St. Jude Medical Supreme Diagnostic Electrophysiology Catheter 6 Elec. 5-5-5mm
402008RH
402009RH
Reason: These lots of reprocessed catheters may contain small particles of residual material. If affected devices are used, there is a risk of inflammatory response, systemic infection, or granulomatous reaction or thrombus reaction which may lead to cerebral or pulmonary embolism, or deep vein thrombosis. Expansion of recall Z-2610/2614-2025
Root cause: Under Investigation by firm
Recalling firm: Medline Industries, LPType: Catheter, Recording, Electrode, ReprocessedDistribution: Distribution US nationwide.Recall #Z-1322-2026
Open, ClassifiedPosted Feb 6, 2026·Initiated Dec 22, 2025
Medline ReNewal Reprocessed ViewFlex Xtra ICE Catheters:
ViewFlex Xtra ICE Catheter 9F x 90cm
D087031RH
20197344019554
Reason: These lots of reprocessed catheters may contain small particles of residual material. If affected devices are used, there is a risk of inflammatory response, systemic infection, or granulomatous reaction or thrombus reaction which may lead to cerebral or pulmonary embolism, or deep vein thrombosis. Expansion of recall Z-2610/2614-2025
Root cause: Under Investigation by firm
Recalling firm: Medline Industries, LPType: Reprocessed Intravascular Ultrasound CatheterDistribution: Distribution US nationwide.Recall #Z-1323-2026
Open, ClassifiedPosted Feb 6, 2026·Initiated Dec 22, 2025
Reprocessed Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound Catheters:
Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound Catheter Use on GE Systems
10439072RH;
Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound Catheter Use on Siemens Systems
10438577RH;
Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound Catheter, Use on Siemens Systems
10439011RH
Reason: These lots of reprocessed catheters may contain small particles of residual material. If affected devices are used, there is a risk of inflammatory response, systemic infection, or granulomatous reaction or thrombus reaction which may lead to cerebral or pulmonary embolism, or deep vein thrombosis. Expansion of recall Z-2610/2614-2025
Root cause: Under Investigation by firm
Recalling firm: Medline Industries, LPType: Reprocessed Intravascular Ultrasound CatheterDistribution: Distribution US nationwide.Recall #Z-1324-2026
Open, ClassifiedPosted Feb 6, 2026·Initiated Dec 22, 2025
Reprocessed Siemens ACUSON AcuNav Diagnostic Ultrasound Catheters:
ACUSON AcuNav Ultrasound Catheter, Use on GE Systems
10135910RH; 10043342RH
ACUSON AcuNav Ultrasound Catheter, Use on Siemens Systems
10135936RH, 08255790RH
Reason: These lots of reprocessed catheters may contain small particles of residual material. If affected devices are used, there is a risk of inflammatory response, systemic infection, or granulomatous reaction or thrombus reaction which may lead to cerebral or pulmonary embolism, or deep vein thrombosis. Expansion of recall Z-2610/2614-2025
Root cause: Under Investigation by firm
Recalling firm: Medline Industries, LPType: Reprocessed Intravascular Ultrasound CatheterDistribution: Distribution US nationwide.Recall #Z-1325-2026
Open, ClassifiedPosted Feb 5, 2026·Initiated Dec 19, 2025
AXIOS Stent and Electrocautery-Enhanced Delivery System - 20mm x 10mm;
Material Number (UPN): M00553660;
Reason: Increased reports of stent deployment and expansion issues. The most common outcome reasonably foreseeable resulting from difficulty deploying the stent is prolongation of the procedure to exchange the device for a new one.
The most serious reasonably foreseeable outcome in cases where the first flange is unable to deploy or expand would be a cascade of events resulting in additional intervention, either endoscopic or surgical, to remove the stent and close the puncture site.
Root cause: Process control
Recalling firm: Boston Scientific CorporationType: Unit, Electrosurgical, Endoscopic (With Or Without Accessories)Distribution: Worldwide distribution. US Nationwide including Puerto Rico; Algeria, Argentina, Austria, Belgium, Brazil, Canada, CHILE, Colombia, Costa Rica, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, India, Indonesia, Iran, Ireland, Israel, Italy, JAPAN, Jordan, Kuwait, Lebanon, Luxembourg, Malaysia, Mexico, Morocco, Netherlands, Norway, Oman, Pakistan, Palestine, Panama, Paraguay, PERU, Poland, Portugal, Romania, Saudi Arabia, Serbia, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, UAE, and United Kingdom.Recall #Z-1158-2026 Open, ClassifiedPosted Feb 5, 2026·Initiated Dec 19, 2025
AXIOS Stent and Electrocautery-Enhanced Delivery System - 6mm x 8mm;
Material Number (UPN): M00553680;
Reason: Increased reports of stent deployment and expansion issues. The most common outcome reasonably foreseeable resulting from difficulty deploying the stent is prolongation of the procedure to exchange the device for a new one.
The most serious reasonably foreseeable outcome in cases where the first flange is unable to deploy or
expand would be a cascade of events resulting in additional intervention, either endoscopic or surgical, to remove the stent and close the puncture site.
Root cause: Process control
Recalling firm: Boston Scientific CorporationType: Unit, Electrosurgical, Endoscopic (With Or Without Accessories)Distribution: Worldwide distribution. US Nationwide including Puerto Rico; Algeria, Argentina, Austria, Belgium, Brazil, Canada, CHILE, Colombia, Costa Rica, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, India, Indonesia, Iran, Ireland, Israel, Italy, JAPAN, Jordan, Kuwait, Lebanon, Luxembourg, Malaysia, Mexico, Morocco, Netherlands, Norway, Oman, Pakistan, Palestine, Panama, Paraguay, PERU, Poland, Portugal, Romania, Saudi Arabia, Serbia, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, UAE, and United Kingdom.Recall #Z-1159-2026 Open, ClassifiedPosted Feb 5, 2026·Initiated Dec 19, 2025
AXIOS Stent and Electrocautery-Enhanced Delivery System - 8mm x 8mm;
Material Number (UPN): M00553690;
Reason: Increased reports of stent deployment and expansion issues. The most common outcome reasonably foreseeable resulting from difficulty deploying the stent is prolongation of the procedure to exchange the device for a new one.
The most serious reasonably foreseeable outcome in cases where the first flange is unable to deploy or
expand would be a cascade of events resulting in additional intervention, either endoscopic or surgical, to remove the stent and close the puncture site.
Root cause: Process control
Recalling firm: Boston Scientific CorporationType: Unit, Electrosurgical, Endoscopic (With Or Without Accessories)Distribution: Worldwide distribution. US Nationwide including Puerto Rico; Algeria, Argentina, Austria, Belgium, Brazil, Canada, CHILE, Colombia, Costa Rica, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, India, Indonesia, Iran, Ireland, Israel, Italy, JAPAN, Jordan, Kuwait, Lebanon, Luxembourg, Malaysia, Mexico, Morocco, Netherlands, Norway, Oman, Pakistan, Palestine, Panama, Paraguay, PERU, Poland, Portugal, Romania, Saudi Arabia, Serbia, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, UAE, and United Kingdom.Recall #Z-1160-2026 Open, ClassifiedPosted Feb 5, 2026·Initiated Dec 19, 2025
HOT AXIOS Stent and Electrocautery-Enhanced Delivery System 6mm x 8mm;
Material Number (UPN): M00553520;
Reason: Increased reports of stent deployment and expansion issues. The most common outcome reasonably foreseeable resulting from difficulty deploying the stent is prolongation of the procedure to exchange the device for a new one.
The most serious reasonably foreseeable outcome in cases where the first flange is unable to deploy or
expand would be a cascade of events resulting in additional intervention, either endoscopic or surgical, to remove the stent and close the puncture site.
Root cause: Process control
Recalling firm: Boston Scientific CorporationType: Unit, Electrosurgical, Endoscopic (With Or Without Accessories)Distribution: Worldwide distribution. US Nationwide including Puerto Rico; Algeria, Argentina, Austria, Belgium, Brazil, Canada, CHILE, Colombia, Costa Rica, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, India, Indonesia, Iran, Ireland, Israel, Italy, JAPAN, Jordan, Kuwait, Lebanon, Luxembourg, Malaysia, Mexico, Morocco, Netherlands, Norway, Oman, Pakistan, Palestine, Panama, Paraguay, PERU, Poland, Portugal, Romania, Saudi Arabia, Serbia, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, UAE, and United Kingdom.Recall #Z-1161-2026 Open, ClassifiedPosted Feb 5, 2026·Initiated Dec 19, 2025
*HOT AXIOS Stent and Electrocautery-Enhanced Delivery System 8mm x 8mm;
Material Number (UPN): M00553530;
Reason: Increased reports of stent deployment and expansion issues. The most common outcome reasonably foreseeable resulting from difficulty deploying the stent is prolongation of the procedure to exchange the device for a new one.
The most serious reasonably foreseeable outcome in cases where the first flange is unable to deploy or
expand would be a cascade of events resulting in additional intervention, either endoscopic or surgical, to remove the stent and close the puncture site.
Root cause: Process control
Recalling firm: Boston Scientific CorporationType: Unit, Electrosurgical, Endoscopic (With Or Without Accessories)Distribution: Worldwide distribution. US Nationwide including Puerto Rico; Algeria, Argentina, Austria, Belgium, Brazil, Canada, CHILE, Colombia, Costa Rica, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, India, Indonesia, Iran, Ireland, Israel, Italy, JAPAN, Jordan, Kuwait, Lebanon, Luxembourg, Malaysia, Mexico, Morocco, Netherlands, Norway, Oman, Pakistan, Palestine, Panama, Paraguay, PERU, Poland, Portugal, Romania, Saudi Arabia, Serbia, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, UAE, and United Kingdom.Recall #Z-1162-2026 Open, ClassifiedPosted Feb 5, 2026·Initiated Dec 19, 2025
*HOT AXIOS Stent and Electrocautery-Enhanced Delivery System 20mm x 10mm;
Material Number (UPN): M00553560;
Reason: Increased reports of stent deployment and expansion issues. The most common outcome reasonably foreseeable resulting from difficulty deploying the stent is prolongation of the procedure to exchange the device for a new one.
The most serious reasonably foreseeable outcome in cases where the first flange is unable to deploy or
expand would be a cascade of events resulting in additional intervention, either endoscopic or surgical, to remove the stent and close the puncture site.
Root cause: Process control
Recalling firm: Boston Scientific CorporationType: Unit, Electrosurgical, Endoscopic (With Or Without Accessories)Distribution: Worldwide distribution. US Nationwide including Puerto Rico; Algeria, Argentina, Austria, Belgium, Brazil, Canada, CHILE, Colombia, Costa Rica, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, India, Indonesia, Iran, Ireland, Israel, Italy, JAPAN, Jordan, Kuwait, Lebanon, Luxembourg, Malaysia, Mexico, Morocco, Netherlands, Norway, Oman, Pakistan, Palestine, Panama, Paraguay, PERU, Poland, Portugal, Romania, Saudi Arabia, Serbia, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, UAE, and United Kingdom.Recall #Z-1163-2026 Open, ClassifiedPosted Feb 5, 2026·Initiated Jan 7, 2026
Brand Name: CleverCut
Product Name: Single Use 3-Lumen Sphincterotome V
Model/Catalog Number: KD-V411M-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-1268-2026
Open, ClassifiedPosted Feb 5, 2026·Initiated Jan 7, 2026
Product Name: Single Use Sphincterotome V (Distal Wire guided)
Model/Catalog Number: KD-VC431Q-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-1269-2026
Open, ClassifiedPosted Feb 5, 2026·Initiated Jan 7, 2026
Product Name: Disposable Triple Lumen Sphincterotome
Model/Catalog Number: KD-431Q-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-1270-2026
Open, ClassifiedPosted Feb 5, 2026·Initiated Jan 7, 2026
Product Name: Single Use 3-Lumen Sphincterotome V
Model/Catalog Number: KD-V411M-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-1271-2026
Open, ClassifiedPosted Feb 5, 2026·Initiated Jan 7, 2026
Product Name: Single Use 3-Lumen Sphincterotome V
Model/Catalog Number: KD-V411M-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-1272-2026
Open, ClassifiedPosted Feb 5, 2026·Initiated Jan 7, 2026
Product Name: Single Use 3-Lumen Sphincterotome V
Model/Catalog Number: KD-V411M-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-1273-2026
Open, ClassifiedPosted Feb 5, 2026·Initiated Jan 7, 2026
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.
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-1274-2026
Open, ClassifiedPosted Feb 5, 2026·Initiated Jan 7, 2026
Product Name: Single Use 3-Lumen Sphincterotome V
Model/Catalog Number: KD-V431M-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-1275-2026
Open, ClassifiedPosted Feb 5, 2026·Initiated Jan 7, 2026
Product Name: Single Use 3-Lumen Sphincterotome V
Model/Catalog Number: KD-V431M-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-1276-2026
Open, ClassifiedPosted Feb 5, 2026·Initiated Jan 7, 2026
Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided)
Model/Catalog Number: KD-VC431Q-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-1277-2026