Class I - Dangerous
Unreleased software versions were installed on distributed devices without verification or validation.
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Medical Devices Recalls
Medical equipment, implants, and diagnostic devices
37,779 Total Recalls
Class I - Dangerous
Potential that the blade can unintentionally cut tissue prior to the user deploying the blade.
Potential for thermal incident including an unexpected occurrence of smoke, sparks, burning, or unsteady flames during clinical use. The fracturing of the fiber is the cause of, or contributes to, these thermal incidents.
Class I - Dangerous
Identified devices may experience sudden battery power failure without alarm, power supply power-on-resets, and interruption of therapy. Potential patient harms include insufficient pacing support leading to cardiac arrest, syncope, or hospitalization; or system revision (explant/replacement) leading to infection, hematoma, or temporary impairment.
BD Texium Needle-Free Syringe: 3 mL, REF: MY8003; 5 mL, REF: MY8005; 10 mL, REF: MY8010; 20 mL, REF: MY8020; 30 mL, REF: MY8030; 60 mL, REF: MY8060
BD SWITZERLAND SARL
Class I - Dangerous
Sterile, single use closed system drug transfer devices, standalone or on infusion sets or bonded syringes, may leak at the interface between the closed male luer component and the needle-free connector, which may cause procedure delay, treatment interruptions, exposure to hazardous drugs, and/or underdosing of medication.
Due to a software bug the robotic arm may incorrectly guide the instrument compared to the planning defined by user.
Class I - Dangerous
Product may have an off color affecting perfomance
Sterility assurance for Ophthalmic knives.
2.5 V replacement rechargeable batteries for Hillrom WELCH ALLYN PocketScope handles, Product Code 72600
Baxter Healthcare
Class I - Dangerous
The replacement rechargeable batteries inserted into the Welch Allyn PocketScope handles have the potential to cause a short circuit in the handle, which can lead to exposure to excessive heat and user burns.
Intera 1.5T Explorer/Nova Dual Product Number: 781108;
Philips North America
Class I - Dangerous
identified an issue where a component failure in the specific Gradient Coil type of affected systems can potentially act as a heat source, with a potential to produce smoke and/or fire. If smoke or a fire occurs, the risk to patients or operators may include inhalation of smoke, burns, and/or asphyxia which may lead to injury or even death. This issue could also lead to property damage.
SmartPath to dStream for 1.5T¿; Product Number: 782146;
Philips North America
Class I - Dangerous
identified an issue where a component failure in the specific Gradient Coil type of affected systems can potentially act as a heat source, with a potential to produce smoke and/or fire. If smoke or a fire occurs, the risk to patients or operators may include inhalation of smoke, burns, and/or asphyxia which may lead to injury or even death. This issue could also lead to property damage.
Class I - Dangerous
Unreleased software versions were installed on distributed devices without verification or validation.
Intera 1.5T Achieva IT Nova Product Number: 781175
Philips North America
Class I - Dangerous
identified an issue where a component failure in the specific Gradient Coil type of affected systems can potentially act as a heat source, with a potential to produce smoke and/or fire. If smoke or a fire occurs, the risk to patients or operators may include inhalation of smoke, burns, and/or asphyxia which may lead to injury or even death. This issue could also lead to property damage.
Baxter Novum IQ Syringe Pump, product code 40800BAXUS,
Baxter Healthcare
Class I - Dangerous
Baxter has identified a design issue which may cause the pump to detect the presence of a syringe flange when no syringe is loaded. When this issue occurs, the pumps 'user interface becomes stuck on the "Remove Syringe" screen when an infusion is complete, and the syringe is unloaded. A System Error 21502 (Flange Sensor Failure) may occur. Please note this issue only affects a subset of Novum IQ syringe pumps manufactured or repaired after July 4, 2023.
SCD Comfort Knee Length Small, SKU 84021; Kendall SCD Small Comfort sleeves when used with the Kendall SCD Smartflow Controller
Cardinal Health 200
Class I - Dangerous
Incorrect software logic may cause frequent E1 errors (system high pressure). Issue may cause delay in treatment or therapy.
BD TEXIUM CLOSED MALE LUER WITH FEMALE CAP, REF: 10012241; BD TEXIUM (China), REF: 10012241 CHINA
BD SWITZERLAND SARL
Class I - Dangerous
Sterile, single use closed system drug transfer devices, standalone or on infusion sets or bonded syringes, may leak at the interface between the closed male luer component and the needle-free connector, which may cause procedure delay, treatment interruptions, exposure to hazardous drugs, and/or underdosing of medication.
Sterility assurance for Ophthalmic knives.
Contamac, Nutrifill Physiologic formula, Contact Lens Insertion solution
Contamac Solutions
Class I - Dangerous
Contact lens insertion solution may lack sterility.
Sterile, single use closed system drug transfer devices, standalone or on infusion sets or bonded syringes, may leak at the interface between the closed male luer component and the needle-free connector, which may cause procedure delay, treatment interruptions, exposure to hazardous drugs, and/or underdosing of medication.
Class I - Dangerous
Investigation determined that one lot of the T2 Greater Trochanter Nail (GTN) was labeled as left version but contained a right nail and another lot was labeled as right version but contained a left nail.