Open, ClassifiedPosted Oct 11, 2024·Initiated Aug 22, 2024
KINOVA Jaco assistive robot. Model Numbers: PJ 0000 0001, PJ 0000 0012, PJ 0090 0001, PJ 0090 0006, KR MJ2 0001. Jaco replaces the function of the upper limb on one side of the body.
Reason: Potential installation issue that could result in a fire hazard in the event of an interaction between a damaged Jaco arm and a wheelchair exhibiting electrical leakage.
Root cause: Device Design
Recalling firm: Kinova IncType: Hand, External Limb Component, PoweredDistribution: Worldwide - US Nationwide distribution in the states of California, Missouri, North Carolina, Ohio and the countries of Australia, Canada, China, Czechia, France, Germany, Netherlands, Norway, Portugal, Switzerland, Great Britain, Northern Ireland.Recall #Z-0049-2025
Open, ClassifiedPosted Oct 11, 2024·Initiated Sep 14, 2023
EVIS EXERA III Video System Center Model Number CV-190. Intended to be used with OLYMPUS camera heads, endoscopes, light sources, monitors, EndoTherapy accessories, and other ancillary equipment for endoscopic diagnosis, treatment, and video observation
Reason: Certain serial numbers of the CV-190 do not start up properly because parts that deviated from the specification were assembled into the power supply unit.
Root cause: Nonconforming Material/Component
Recalling firm: Olympus Corporation of the AmericasType: Colonoscope And Accessories, Flexible/RigidDistribution: US Nationwide distribution.Recall #Z-0056-2025
Open, ClassifiedPosted Oct 11, 2024·Initiated Aug 30, 2024
Monarch Inflation Device 30 atm/bar REF IN2130
Injector And Syringe, Angiographic/Syringe, Balloon Inflation - The 30 ATM Monarch syringe is used to inflate and deflate balloon angioplasty catheters and to measure the pressure within the balloon during the procedure. It is also used to inject fluids into the body and to monitor the pressure of that fluid.
Reason: Due to a manufacturing process resulting in holes/breaches in the Tyvek sterile barrier.
Root cause: Nonconforming Material/Component
Recalling firm: Merit Medical Systems, Inc.Type: Injector And Syringe, AngiographicDistribution: Worldwide - U.S. Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY. The countries of Belgium, Canada, France, Japan, Monaco, Netherlands, Qatar, United Arab Emirates, United Kingdom.Recall #Z-0057-2025 Open, ClassifiedPosted Oct 11, 2024·Initiated Aug 30, 2024
Monarch Inflation Device MAP 112 Access-9 Large Bore Hemostasis Value Metal Insertion Tool Torque DeviceREF IN2230
Injector And Syringe, Angiographic/Syringe, Balloon Inflation - The 30 ATM Monarch syringe is used to inflate and deflate balloon angioplasty catheters and to measure the pressure within the balloon during the procedure. It is also used to inject fluids into the body and to monitor the pressure of that fluid.
Reason: Due to a manufacturing process resulting in holes/breaches in the Tyvek sterile barrier.
Root cause: Nonconforming Material/Component
Recalling firm: Merit Medical Systems, Inc.Type: Injector And Syringe, AngiographicDistribution: Worldwide - U.S. Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY. The countries of Belgium, Canada, France, Japan, Monaco, Netherlands, Qatar, United Arab Emirates, United Kingdom.Recall #Z-0058-2025 Open, ClassifiedPosted Oct 11, 2024·Initiated Aug 30, 2024
Monarch Inflation Device 30 atm/bar MAP302 Honor Hemostasis Valve Metal Insertion Tool Torque Device REF IN2330
Injector And Syringe, Angiographic/Syringe, Balloon Inflation - The 30 ATM Monarch syringe is used to inflate and deflate balloon angioplasty catheters and to measure the pressure within the balloon during the procedure. It is also used to inject fluids into the body and to monitor the pressure of that fluid.
Reason: Due to a manufacturing process resulting in holes/breaches in the Tyvek sterile barrier.
Root cause: Nonconforming Material/Component
Recalling firm: Merit Medical Systems, Inc.Type: Injector And Syringe, AngiographicDistribution: Worldwide - U.S. Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY. The countries of Belgium, Canada, France, Japan, Monaco, Netherlands, Qatar, United Arab Emirates, United Kingdom.Recall #Z-0059-2025 Open, ClassifiedPosted Oct 11, 2024·Initiated Aug 30, 2024
Monarch Inflation Device 30 atm/bar MAP403 MBA Hemostasis Valve Metal Insertion Tool Torque Device REF IN2430
Injector And Syringe, Angiographic/Syringe, Balloon Inflation - The 30 ATM Monarch syringe is used to inflate and deflate balloon angioplasty catheters and to measure the pressure within the balloon during the procedure. It is also used to inject fluids into the body and to monitor the pressure of that fluid.
Reason: Due to a manufacturing process resulting in holes/breaches in the Tyvek sterile barrier.
Root cause: Nonconforming Material/Component
Recalling firm: Merit Medical Systems, Inc.Type: Injector And Syringe, AngiographicDistribution: Worldwide - U.S. Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY. The countries of Belgium, Canada, France, Japan, Monaco, Netherlands, Qatar, United Arab Emirates, United Kingdom.Recall #Z-0060-2025 Open, ClassifiedPosted Oct 11, 2024·Initiated Aug 30, 2024
Monarch Inflation Device 30 atm/bar MAP152 AssessPLUS Large Bore Hemostasis Valve Metal Insertion Tool Torque Device REF IN2530
Injector And Syringe, Angiographic/Syringe, Balloon Inflation - The 30 ATM Monarch syringe is used to inflate and deflate balloon angioplasty catheters and to measure the pressure within the balloon during the procedure. It is also used to inject fluids into the body and to monitor the pressure of that fluid.
Reason: Due to a manufacturing process resulting in holes/breaches in the Tyvek sterile barrier.
Root cause: Nonconforming Material/Component
Recalling firm: Merit Medical Systems, Inc.Type: Injector And Syringe, AngiographicDistribution: Worldwide - U.S. Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY. The countries of Belgium, Canada, France, Japan, Monaco, Netherlands, Qatar, United Arab Emirates, United Kingdom.Recall #Z-0061-2025 Open, ClassifiedPosted Oct 11, 2024·Initiated Aug 30, 2024
Melrose Wakefield Hospital REF K05T-2159
Injector And Syringe, Angiographic/Syringe, Balloon Inflation - The 30 ATM Monarch syringe is used to inflate and deflate balloon angioplasty catheters and to measure the pressure within the balloon during the procedure. It is also used to inject fluids into the body and to monitor the pressure of that fluid.
Reason: Due to a manufacturing process resulting in holes/breaches in the Tyvek sterile barrier.
Root cause: Nonconforming Material/Component
Recalling firm: Merit Medical Systems, Inc.Type: Injector And Syringe, AngiographicDistribution: Worldwide - U.S. Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY. The countries of Belgium, Canada, France, Japan, Monaco, Netherlands, Qatar, United Arab Emirates, United Kingdom.Recall #Z-0062-2025 Open, ClassifiedPosted Oct 11, 2024·Initiated Sep 5, 2024
1.2mm Cross Cut Fissure - Intended for use in the cutting, drilling, reaming,
decorticating, shaping and smoothing of bone, bone cement and teeth in a variety of surgical procedures including but not limited to dental, ENT (ear, nose and throat), neuro, spine and endoscopic applications
Catalog Number: 5820-066-012
Reason: May exhibit endotoxin levels greater than 2.15 EU/device, fever and inflammation may occur from endotoxin exposure and meningitis may only occur if there is contact with cerebrospinal fluid and thus, neurosurgical/spinal procedures may be considered a population at greatest risk.
Root cause: Process control
Recalling firm: Stryker CorporationType: Drills, Burrs, Trephines & Accessories (Simple, Powered)Distribution: Worldwide distribution - US Nationwide and the countries of Canada, Columbia.Recall #Z-0063-2025
Open, ClassifiedPosted Oct 11, 2024·Initiated Aug 19, 2024
Blue Diamond Digital Inflation Device, REF: IN7152/C, IN7352/C, IN7403/C, IN7802/C, IN7852/C, IN7130/C
Reason: Inflation devices may have a small hole in the sterile barrier of the device and use of affected devices may result in exposure to pathogens/pyrogens which could lead to infection.
Root cause: Packaging process control
Recalling firm: Merit Medical Systems, Inc.Type: Injector And Syringe, AngiographicDistribution: Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV and the countries of France, Italy, Jamaica, Ireland, Paraguay, Australia, India, Nepal, Japan.Recall #Z-0064-2025 Open, ClassifiedPosted Oct 11, 2024·Initiated Aug 19, 2024
basixTOUCH Inflation Device, REF: IN8140/A
Reason: Inflation devices may have a small hole in the sterile barrier of the device and use of affected devices may result in exposure to pathogens/pyrogens which could lead to infection.
Root cause: Packaging process control
Recalling firm: Merit Medical Systems, Inc.Type: Syringe, Balloon Inflation, ExemptDistribution: Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV and the countries of France, Italy, Jamaica, Ireland, Paraguay, Australia, India, Nepal, Japan.Recall #Z-0065-2025 Open, ClassifiedPosted Oct 11, 2024·Initiated Aug 19, 2024
DiamondTOUCH Digital Inflation Device, REF: IN9135/A, IN9152/A
Reason: Inflation devices may have a small hole in the sterile barrier of the device and use of affected devices may result in exposure to pathogens/pyrogens which could lead to infection.
Root cause: Packaging process control
Recalling firm: Merit Medical Systems, Inc.Type: Injector And Syringe, AngiographicDistribution: Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV and the countries of France, Italy, Jamaica, Ireland, Paraguay, Australia, India, Nepal, Japan.Recall #Z-0066-2025 Open, ClassifiedPosted Oct 11, 2024·Initiated Aug 19, 2024
IntelliSystem Inflation Device, REF: IN1525/D
Reason: Inflation devices may have a small hole in the sterile barrier of the device and use of affected devices may result in exposure to pathogens/pyrogens which could lead to infection.
Root cause: Packaging process control
Recalling firm: Merit Medical Systems, Inc.Type: Injector And Syringe, AngiographicDistribution: Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV and the countries of France, Italy, Jamaica, Ireland, Paraguay, Australia, India, Nepal, Japan.Recall #Z-0067-2025 Open, ClassifiedPosted Oct 11, 2024·Initiated Aug 19, 2024
BlueFIRE Inflation Device, REF: IN10140
Reason: Inflation devices may have a small hole in the sterile barrier of the device and use of affected devices may result in exposure to pathogens/pyrogens which could lead to infection.
Root cause: Packaging process control
Recalling firm: Merit Medical Systems, Inc.Type: Syringe, Balloon Inflation, ExemptDistribution: Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV and the countries of France, Italy, Jamaica, Ireland, Paraguay, Australia, India, Nepal, Japan.Recall #Z-0068-2025 Open, ClassifiedPosted Oct 11, 2024·Initiated Aug 19, 2024
MONARCH Inflation Device, REF: IN2430/B, IN2530/B, IN2130/B
Reason: Inflation devices may have a small hole in the sterile barrier of the device and use of affected devices may result in exposure to pathogens/pyrogens which could lead to infection.
Root cause: Packaging process control
Recalling firm: Merit Medical Systems, Inc.Type: Injector And Syringe, AngiographicDistribution: Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV and the countries of France, Italy, Jamaica, Ireland, Paraguay, Australia, India, Nepal, Japan.Recall #Z-0069-2025 Open, ClassifiedPosted Oct 11, 2024·Initiated Aug 19, 2024
Custom Inflation Kit, REF: K05-00052M, K05-00053H, K05-00109G, K05-00137K, K05-00296L, K05-00399D, K05-00404C, K05-00410G, K05-00438G, K05-00502F, K05-00564L, K05-00587D, K05-00612Q, K05-00704F, K05-00724F, K05-00793B, K05-00798, K05-00890D, K05-00890D, K05-00944D, K05-00956D, K05-01018C, K05-01051, K05-01104G, K05-01140D, K05-01194G, K05-01274D, K05-01304A, K05-01756B, K05-01820B, K05-01853A, K05-01855L, K05-01895A, K05-01933A, K05-02161, K05-02431A, K05-02487A, K05-02489C, K05-02495B, K05-02554, K05-02573, K05-02575, K05-02595, K05-02595, K05-02657A, K05-02810, K05-02887, K05-03069A, K05-03095B, K05-03112, K05-03124, K05-03150, K05-50037G
Reason: Inflation devices may have a small hole in the sterile barrier of the device and use of affected devices may result in exposure to pathogens/pyrogens which could lead to infection.
Root cause: Packaging process control
Recalling firm: Merit Medical Systems, Inc.Type: Angiography/Angioplasty KitDistribution: Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV and the countries of France, Italy, Jamaica, Ireland, Paraguay, Australia, India, Nepal, Japan.Recall #Z-0070-2025 Open, ClassifiedPosted Oct 11, 2024·Initiated Aug 19, 2024
basixSKY Inflation Device, REF: SKY1802
Reason: Inflation devices may have a small hole in the sterile barrier of the device and use of affected devices may result in exposure to pathogens/pyrogens which could lead to infection.
Root cause: Packaging process control
Recalling firm: Merit Medical Systems, Inc.Type: Syringe, Balloon Inflation, ExemptDistribution: Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV and the countries of France, Italy, Jamaica, Ireland, Paraguay, Australia, India, Nepal, Japan.Recall #Z-0071-2025 Open, ClassifiedPosted Oct 11, 2024·Initiated Aug 19, 2024
basixTOUCH Inflation Device, REF: IN8130/JPC, IN8152/C, IN8302/C, IN8352/C, IN8802/C, IN8130/C, IN8130/C
Reason: Inflation devices may have a small hole in the sterile barrier of the device and use of affected devices may result in exposure to pathogens/pyrogens which could lead to infection.
Root cause: Packaging process control
Recalling firm: Merit Medical Systems, Inc.Type: Syringe, Balloon Inflation, ExemptDistribution: Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV and the countries of France, Italy, Jamaica, Ireland, Paraguay, Australia, India, Nepal, Japan.Recall #Z-0072-2025 Open, ClassifiedPosted Oct 11, 2024·Initiated Aug 19, 2024
StabiliT TOUCH Syringe, REF: IN8VCF/B
Reason: Inflation devices may have a small hole in the sterile barrier of the device and use of affected devices may result in exposure to pathogens/pyrogens which could lead to infection.
Root cause: Packaging process control
Recalling firm: Merit Medical Systems, Inc.Type: Injector, Vertebroplasty (Does Not Contain Cement)Distribution: Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV and the countries of France, Italy, Jamaica, Ireland, Paraguay, Australia, India, Nepal, Japan.Recall #Z-0073-2025 Open, ClassifiedPosted Oct 10, 2024·Initiated Aug 22, 2024
StealthStation S8 App versions 1.3.0 and 1.3.2, (Model # 9735762)
The StealthStation System, with StealthStation Spine software, is intended as an aid for precisely locating anatomical structures in either open or percutaneous neurosurgical and orthopedic procedures.
Reason: Due to two software anomalies that can occur within a spine procedure. Two issues are:
1. Navigation Orientation - when lateral orientation radiographic images are taken, information may appear flipped when utilizing the system (180 degree flipped).
2. Pop-up Message - when using CT+Fluouroscopy images with a slice spacing thickness greater than 2mm, the system does not display a pop-up message indicating the slice spacing is not optimal.
Root cause: Software design
Recalling firm: Medtronic Navigation, Inc.Type: Orthopedic Stereotaxic InstrumentDistribution: Worldwide - U.S Nationwide distribution including in the states of AK, AR, AZ, CA, CO, CT, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NH, NM, NV, NY, OH, OK, PA, Puerto Rico, SC, TN, TX, UT, VA, WA, WI and WV. The countries of Argentina, AUSTRALIA,
AUSTRIA, BAHRAIN, BANGLADESH, BELGIUM, Brazil, BULGARIA, CANADA, CHILE, China,
Colombia, Costa Rica, CROATIA, CYPRUS, DENMARK, EGYPT, EL SALVADOR, FINLAND,
FRANCE, GERMANY, GREECE, GUADELOUPE, HUNGARY, ICELAND, India, ISRAEL, ITALY,
Japan, Jordan, KAZAKHSTAN, KENYA, LEBANON, LIBYAN ARAB JAMAHIRIYA, LITHUANIA,
Malaysia, MARTINIQUE, MEXICO, MOROCCO, NETHERLANDS, NICARAGUA, OMAN, PAKISTAN, PANAMA, Philippines, POLAND, PUERTO RICO, QATAR, Republic of Korea,
ROMANIA, RUSSIAN FEDERATION, SAUDI ARABIA, SERBIA, Singapore, SLOVAKIA, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, Turkey,
UKRAINE, UNITED ARAB EMIRATES, UNITED KINGDOM.Recall #Z-0050-2025