Open, ClassifiedPosted Nov 13, 2024·Initiated Oct 4, 2024
Stryker Neptune SafeAir Smoke Evacuation Pencil Coated Rocker-Switch, Bulk Non-Sterile - Designed for general electrosurgical applications including cutting and coagulation and for removing smoke generated by electrosurgery when used in conjunction with an effective smoke evacuation system.
Catalog Number: 0703-047-002
Reason: There is a potential for the product to activate without manual input when plugged into a power source or remain active after buttons are released. Unintentional activation of the device may result in localized burns to the patient or physician from electrical currents
carried through conductive objects or fluids. Medical/surgical intervention may be needed to correct these injuries
Root cause: Under Investigation by firm
Recalling firm: Stryker CorporationType: Electrosurgical, Cutting & Coagulation & AccessoriesDistribution: Worldwide distribution - US Nationwide and the countries of Canada, Japan, Australia.Recall #Z-0366-2025
Open, ClassifiedPosted Nov 13, 2024·Initiated Oct 4, 2024
Stryker Neptune SafeAir Rocker-Switch Smoke Evacuation Pencil, Non-coated, 70mm - Designed for general electrosurgical applications including cutting and coagulation and for removing smoke generated by electrosurgery when used in conjunction with an effective smoke evacuation system.
Catalog Number: 0703-047-001
Reason: There is a potential for the product to activate without manual input when plugged into a power source or remain active after buttons are released. Unintentional activation of the device may result in localized burns to the patient or physician from electrical currents
carried through conductive objects or fluids. Medical/surgical intervention may be needed to correct these injuries
Root cause: Under Investigation by firm
Recalling firm: Stryker CorporationType: Electrosurgical, Cutting & Coagulation & AccessoriesDistribution: Worldwide distribution - US Nationwide and the countries of Canada, Japan, Australia.Recall #Z-0367-2025
Open, ClassifiedPosted Nov 13, 2024·Initiated Oct 4, 2024
Stryker Neptune SafeAir Smoke Evacuation Pencil, Coated, 70mm Blade, Push Button Switch - Designed for general electrosurgical applications including cutting and coagulation and for removing smoke generated by electrosurgery when used in
conjunction with an effective smoke evacuation system.
Catalog Number: 0703-046-000
Reason: There is a potential for the product to activate without manual input when plugged into a power source or remain active after buttons are released. Unintentional activation of the device may result in localized burns to the patient or physician from electrical currents
carried through conductive objects or fluids. Medical/surgical intervention may be needed to correct these injuries
Root cause: Under Investigation by firm
Recalling firm: Stryker CorporationType: Electrosurgical, Cutting & Coagulation & AccessoriesDistribution: Worldwide distribution - US Nationwide and the countries of Canada, Japan, Australia.Recall #Z-0368-2025
Open, ClassifiedPosted Nov 13, 2024·Initiated Oct 4, 2024
Stryker Neptune SafeAir Smoke Evacuation Pencil Non coated 70 mm Blade Push-Button - Designed for general electrosurgical applications including cutting and coagulation and for removing smoke generated by electrosurgery when used in conjunction with an effective smoke evacuation system.
Catalog Number: 0703-046-001
Reason: There is a potential for the product to activate without manual input when plugged into a power source or remain active after buttons are released. Unintentional activation of the device may result in localized burns to the patient or physician from electrical currents
carried through conductive objects or fluids. Medical/surgical intervention may be needed to correct these injuries
Root cause: Under Investigation by firm
Recalling firm: Stryker CorporationType: Electrosurgical, Cutting & Coagulation & AccessoriesDistribution: Worldwide distribution - US Nationwide and the countries of Canada, Japan, Australia.Recall #Z-0369-2025
Open, ClassifiedPosted Nov 13, 2024·Initiated Oct 4, 2024
Stryker Neptune SafeAir Smoke Evacuation Pencil Coated Push-Button, Bulk Non-sterile - Designed for general electrosurgical applications including cutting and coagulation and for removing smoke generated by electrosurgery when used in conjunction with an effective smoke evacuation system. The pencil enables the operator to remotely conduct an electrosurgical current from the output connector of an electrosurgical unit to the operative site for the desired surgical effect.
Catalog Number: 0703-046-002
Reason: There is a potential for the product to activate without manual input when plugged into a power source or remain active after buttons are released. Unintentional activation of the device may result in localized burns to the patient or physician from electrical currents
carried through conductive objects or fluids. Medical/surgical intervention may be needed to correct these injuries
Root cause: Under Investigation by firm
Recalling firm: Stryker CorporationType: Electrosurgical, Cutting & Coagulation & AccessoriesDistribution: Worldwide distribution - US Nationwide and the countries of Canada, Japan, Australia.Recall #Z-0370-2025
Open, ClassifiedPosted Nov 13, 2024·Initiated Sep 4, 2024
The EVSRF catheter is a sterile, single-use disposable medical device for endovenous radiofrequency ablation, a procedure in which a refluxing vein is thermally coagulated to permanently eliminate the vein from blood circulation. The catheter has a long shaft for insertion into a vein, a handle with start/stop button, and a connector cable. The catheter shaft has a heating element that is energized by the digiRF radiofrequency generator, which is a multi-voltage energy delivery system with touchscreen control that automatically sets the non-adjustable treatment parameters for the catheter. A button on the catheter (or a foot pedal attached to the generator) begins an automated treatment cycle of 20 seconds long at a set temperature of 120 C, and the treatment stops automatically when complete. The catheter is used within a sterile operative field, while the generator remains outside the sterile operative field at all times.
Reason: The Venclose" RF Ablation Catheters may have been manufactured with internal wiring error. The red and yellow signal wires were soldered on swapped ports of the catheter PCB. This error in wire configuration would lead to power being applied through the proximal 3/4th of the heating coil, bypassing the thermocouple, which will then cause the generator to overdrive the catheter in an attempt to reach desired temperature set point. The wire attachment error causes the device to reach temperatures exceeding the levels intended for therapeutic efficacy, while the console is falsely indicating that temperature has not yet been reached, thus increasing the risk of harm due to excessive temperature.
Root cause: Employee error
Recalling firm: Bard Peripheral Vascular IncType: Electrosurgical, Cutting & Coagulation & AccessoriesDistribution: Worldwide - U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, Puerto Rico, SC, SD, TN, TX, UT, VA, WA, WI and WV. The countries of Australia, Singapore, Austria, Belgium, Czechia, Denmark, France, Germany, Greece, Ireland, Italy, Poland, Slovenia Spain, Sweden, Switzerland, United Kingdom, United Arab Emirates, and South Africa.
Open, ClassifiedPosted Nov 13, 2024·Initiated Sep 18, 2024
Medtronic Recharger Kits, RS6230, RS7230, and RS5220A, containing components WR9230 and WR9220A Recharger for rechargeable implantable neurostimulators. The Rechargers are used with Neurostimulator Inceptiv INS Model 977119 and Percept RC INS Model B35300 as part of the Deep Brain Stimulation (DBS) system. WR9220A is used with InterStim Micro, Model 97810, as part of Pelvic Health system
Reason: The Wireless Rechargers in the kits may be unable to enter a recharging session upon first use.
Root cause: Under Investigation by firm
Recalling firm: Medtronic NeuromodulationType: Stimulator, Spinal-Cord, Totally Implanted For Pain ReliefDistribution: Worldwide - US Nationwide distribution in the states of AL, AZ, CA, FL, GA, ID, MD, MI, MN, MO, NC, NJ, OH, PA, SC, TX, VA, and WA. The countries of Austria, Belgium, Denmark, Finland, Germany, Ireland, Italy, Japan, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland, and United Kingdom.Recall #Z-0372-2025
Open, ClassifiedPosted Nov 12, 2024·Initiated Oct 10, 2024
Boston Scientific POLARx BALLOON CATHETER ST 28MM OUS, Material Number M004CRBS2000.
Reason: Boston Scientific is updating the instructions for use of their POLARx and POLARx FIT Cryoablation Balloon Catheters related to Atrio-esophageal Fistula Risk.
Root cause: Device Design
Recalling firm: Boston Scientific CorporationType: Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial FibrillationDistribution: WorldwideRecall #Z-0297-2025 Open, ClassifiedPosted Nov 12, 2024·Initiated Oct 10, 2024
Boston Scientific POLARx BALLOON CATHETER LT 28MM OUS, Material Number M004CRBS2100
Reason: Boston Scientific is updating the instructions for use of their POLARx and POLARx FIT Cryoablation Balloon Catheters related to Atrio-esophageal Fistula Risk.
Root cause: Device Design
Recalling firm: Boston Scientific CorporationType: Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial FibrillationDistribution: WorldwideRecall #Z-0298-2025 Open, ClassifiedPosted Nov 12, 2024·Initiated Oct 10, 2024
Boston Scientific POLARx FIT BALLOON CATHETER ST OUS, Material Number M004CRBS2010
Reason: Boston Scientific is updating the instructions for use of their POLARx and POLARx FIT Cryoablation Balloon Catheters related to Atrio-esophageal Fistula Risk.
Root cause: Device Design
Recalling firm: Boston Scientific CorporationType: Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial FibrillationDistribution: WorldwideRecall #Z-0299-2025 Open, ClassifiedPosted Nov 12, 2024·Initiated Oct 10, 2024
Boston Scientific POLARx FIT BALLOON CATHETER ST US, Material Number M004CRBS2060
Reason: Boston Scientific is updating the instructions for use of their POLARx and POLARx FIT Cryoablation Balloon Catheters related to Atrio-esophageal Fistula Risk.
Root cause: Device Design
Recalling firm: Boston Scientific CorporationType: Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial FibrillationDistribution: WorldwideRecall #Z-0300-2025 Open, ClassifiedPosted Nov 12, 2024·Initiated Oct 10, 2024
Boston Scientific POLARx FIT BALLOON CATHETER LT OUS, Material Number M004CRBS2110
Reason: Boston Scientific is updating the instructions for use of their POLARx and POLARx FIT Cryoablation Balloon Catheters related to Atrio-esophageal Fistula Risk.
Root cause: Device Design
Recalling firm: Boston Scientific CorporationType: Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial FibrillationDistribution: WorldwideRecall #Z-0301-2025 Open, ClassifiedPosted Nov 12, 2024·Initiated Oct 10, 2024
Boston Scientific POLARx FIT BALLOON CATHETER LT US, Material Number M004CRBS2160
Reason: Boston Scientific is updating the instructions for use of their POLARx and POLARx FIT Cryoablation Balloon Catheters related to Atrio-esophageal Fistula Risk.
Root cause: Device Design
Recalling firm: Boston Scientific CorporationType: Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial FibrillationDistribution: WorldwideRecall #Z-0302-2025 Open, ClassifiedPosted Nov 12, 2024·Initiated Oct 10, 2024
Boston Scientific SMARTFREEZE CRYO CONSOLE:
Console: Material Number M004CRBS4000; CONSOLE REFURB: Material Number M004CRBS400R0; CONSOLE HOSPITAL, Material Number M004CRBS400H0, CONSOLE ZERO, Material Number M004CRBS400Z0
Reason: Boston Scientific is updating the instructions for use of their POLARx and POLARx FIT Cryoablation Balloon Catheters related to Atrio-esophageal Fistula Risk.
Root cause: Device Design
Recalling firm: Boston Scientific CorporationType: Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial FibrillationDistribution: WorldwideRecall #Z-0303-2025 Open, ClassifiedPosted Nov 12, 2024·Initiated Oct 7, 2024
Philips Zenition 50, Model Number: 718096
Reason: Potential for the Mains Control Unit board fuse may blow out during system start-up or during a procedure.
Root cause: Under Investigation by firm
Recalling firm: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Type: Interventional Fluoroscopic X-Ray SystemDistribution: Worldwide distribution - US Nationwide and the countries of Albania, Algeria, Argentina, Australia, Austria, Bahrain, Bangladesh, Belgium, Bolivia, Brazil, Bulgaria, Chile, China, Colombia, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Estonia, Faroe Islands, Fiji, Finland, France, French Guiana, Germany, Gibraltar, Greece, Guatemala, Hong Kong, Hungary, Iceland, India, Indonesia, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Korea, Republic of, Kuwait, Lao People's Democratic Republic, Lebanon, Lithuania, Malaysia, Malta, Martinique, Mauritius, Mexico, Morocco, Myanmar, Netherlands, New Zealand, Nicaragua, Nigeria, Norway, Pakistan, Palestine, State of, Panama, Peru, Philippines, Poland, Portugal, R¿union, Romania, Russian Federation, Rwanda, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, Spain, Suriname, Sweden, Switzerland, Taiwan, Thailand, Trinidad and Tobago, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan, Viet Nam, Yemen.Recall #Z-0352-2025
Open, ClassifiedPosted Nov 12, 2024·Initiated Oct 7, 2024
Philips Zenition 70, Model Number: 718133
Reason: Potential for the Mains Control Unit board fuse may blow out during system start-up or during a procedure.
Root cause: Under Investigation by firm
Recalling firm: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Type: Interventional Fluoroscopic X-Ray SystemDistribution: Worldwide distribution - US Nationwide and the countries of Albania, Algeria, Argentina, Australia, Austria, Bahrain, Bangladesh, Belgium, Bolivia, Brazil, Bulgaria, Chile, China, Colombia, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Estonia, Faroe Islands, Fiji, Finland, France, French Guiana, Germany, Gibraltar, Greece, Guatemala, Hong Kong, Hungary, Iceland, India, Indonesia, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Korea, Republic of, Kuwait, Lao People's Democratic Republic, Lebanon, Lithuania, Malaysia, Malta, Martinique, Mauritius, Mexico, Morocco, Myanmar, Netherlands, New Zealand, Nicaragua, Nigeria, Norway, Pakistan, Palestine, State of, Panama, Peru, Philippines, Poland, Portugal, R¿union, Romania, Russian Federation, Rwanda, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, Spain, Suriname, Sweden, Switzerland, Taiwan, Thailand, Trinidad and Tobago, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan, Viet Nam, Yemen.Recall #Z-0353-2025
Open, ClassifiedPosted Nov 12, 2024·Initiated Oct 23, 2024
Clean Catch Kit, SKU DYKM1833A; Component No. 503581
Reason: Specimen container included in kits is labeled as sterile, but has been identified to be non-sterile. Long-term consequences may include unnecessary treatment and/or prolonged hospitalization.
Root cause: Under Investigation by firm
Recalling firm: MEDLINE INDUSTRIES, LP - NorthfieldType: General Surgery TrayDistribution: US Nationwide distribution in the states of AL, CA, FL, GA, IL, KY, MO, MS, MT, TN, TX, VA and WA.Recall #Z-0354-2025
Open, ClassifiedPosted Nov 12, 2024·Initiated Oct 23, 2024
Lab Kit, SKU DYLAB1018; Component No. 503581
Reason: Specimen container included in kits is labeled as sterile, but has been identified to be non-sterile. Long-term consequences may include unnecessary treatment and/or prolonged hospitalization.
Root cause: Under Investigation by firm
Recalling firm: MEDLINE INDUSTRIES, LP - NorthfieldType: General Surgery TrayDistribution: US Nationwide distribution in the states of AL, CA, FL, GA, IL, KY, MO, MS, MT, TN, TX, VA and WA.Recall #Z-0355-2025
Open, ClassifiedPosted Nov 12, 2024·Initiated Oct 23, 2024
UA KIT, SKU DYKM1690A; Component No. 503581
Reason: Specimen container included in kits is labeled as sterile, but has been identified to be non-sterile. Long-term consequences may include unnecessary treatment and/or prolonged hospitalization.
Root cause: Under Investigation by firm
Recalling firm: MEDLINE INDUSTRIES, LP - NorthfieldType: General Surgery TrayDistribution: US Nationwide distribution in the states of AL, CA, FL, GA, IL, KY, MO, MS, MT, TN, TX, VA and WA.Recall #Z-0356-2025
Open, ClassifiedPosted Nov 12, 2024·Initiated Oct 23, 2024
URINALYSIS KIT 4, SKU DYLAB1021; Component No. 503581
Reason: Specimen container included in kits is labeled as sterile, but has been identified to be non-sterile. Long-term consequences may include unnecessary treatment and/or prolonged hospitalization.
Root cause: Under Investigation by firm
Recalling firm: MEDLINE INDUSTRIES, LP - NorthfieldType: General Surgery TrayDistribution: US Nationwide distribution in the states of AL, CA, FL, GA, IL, KY, MO, MS, MT, TN, TX, VA and WA.Recall #Z-0357-2025