Contamac, Nutrifill Physiologic formula, Contact Lens Insertion solution
Contamac Solutions
🏥 Medical Devices Class I - Dangerous
Contact lens insertion solution may lack sterility.
All Recalls
95,102 total recalls in our database
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.
🏥 Medical Devices 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.
🏥 Medical Devices Class I - Dangerous
A software issue where "low" and "terminal" battery alerts did not display on the screen to the user in specific circumstances when the device was not running patient therapy.
🏥 Medical Devices Class I - Dangerous
Sterility assurance for Ophthalmic knives.
Long Nail, RIGHT Gamma4 10x320mm x 125, component of the Gamma4 System. Catalog Number: 84250320S.
Stryker GmbH
🏥 Medical Devices Class I - Dangerous
Investigation confirmed that the GAMMA4 Right Long Nail was manufactured with the geometry of a left nail.
BD BBL CultureSwab EZ Collection and Transport System, REF 220144, in vitro Diagnostic, SterileR, Rx Only
Copan Italia
🏥 Medical Devices Class I - Dangerous
Swabs for specimen collection may be prone to breakage during product usage.
Ventilator Printed Circuit Board Assembly may have two separate capacitors that may fail, which may result in the ventilator either shutting down during use, thus necessitating use of an alternate form of ventilation, or the shutdown alert alarm fails to alarm effectively during shut down, which may result in respiratory failure, hypoventilation, low oxygen saturation, hypoxia, treatment delay.
🏥 Medical Devices Class I - Dangerous
Incorrect software logic may cause frequent E1 errors (system high pressure). Issue may cause delay in treatment or therapy.
🏥 Medical Devices 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.
🏥 Medical Devices Class I - Dangerous
Incorrect software logic may cause frequent E1 errors (system high pressure). Issue may cause delay in treatment or therapy.
Allon 2001. Part Number: 200-00263
Belmont Instrument
🏥 Medical Devices Class I - Dangerous
An investigation into a report of the patient wrap (ThermoWrap), used with the Allon device, exceeding the set temperature determined that if: 1. The Human Sensor Board is disconnected from the Controller Board in the Allon device AND the temperature alarms are disabled, or 2. The Water In and Water Out and Thermostat sensors are disconnected from the Human Sensor Board AND the temperature alarms are disabled, the device will proceed to heat the water above the hardware fault limit without notifying the user of the faulty condition.
DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137, running software versions 1.20
Beckman Coulter
🏥 Medical Devices Class I - Dangerous
A new motor/encoder and cable was introduced into instruments manufactured starting with serial number 300141 incorrectly. This incorrect installation is introducing error codes for the Dxl 9000 which prevents the assay from being performed and a delay in results from being generated, and may require field service to resolve the delay.
Intera 1.5T Achieva Nova Product Number: 781172;
Philips North America
🏥 Medical Devices 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.
Intera Achieva 1.5T Pulsar; Product Number: 781171;
Philips North America
🏥 Medical Devices 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.
MUSE 5 Systems, Model Numbers 2021274-001, 2023032-005, 2027478-001, Large capacity client-server-based computer system that accesses stores and manages cardiovascular information.
GE Medical Systems Information Technologies
🏥 Medical Devices Class I - Dangerous
The MUSE Administrator Account active directory or local credential could potentially be used from your local network to log into a GE HealthCare MUSE 5 system and potentially manipulate recorded patient data.
🏥 Medical Devices Class I - Dangerous
Unreleased software versions were installed on distributed devices without verification or validation.
🏥 Medical Devices Class I - Dangerous
Sterility assurance for Ophthalmic knives.
Intera 1.5T Master/Nova Product Number: 781106;
Philips North America
🏥 Medical Devices 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.
🏥 Medical Devices Class I - Dangerous
Sterility assurance for Ophthalmic knives.