🏥 Medical Devices Class I - Dangerous
During internal Age Testing, holes were found in the sterile Tyvek pouches of the devices.
All Recalls
95,114 total recalls in our database
CareLink SmartSync Device Manager - Product Usage: used to treat arrhythmias related to bradycardia. Additionally, CRT-P devices can also provide cardiac resynchronization therapy (CRT) in treatment of heart failure, Model Number 24970A
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
🏥 Medical Devices Class I - Dangerous
A longevity estimation error may occur in the early years of device life when a unipolar pacing vector is programmed in the right atrial (RA) lead and/or the right ventricular (RV) lead. No other device features or therapies are impacted.
VACUETTE¿ Blood Collection tube 9NC Coagulation sodium citrate 3.2% 13x75 blue cap-white ring, sandwich tube, non-ridged - Product Usage: indicated for use in collection and transport of venous whole blood for coagulation testing.
Greiner Bio-One North America
🏥 Medical Devices Class I - Dangerous
VACUETTE¿ Blood Collection tube 9NC Coagulation sodium citrate 3.2% may show insufficient draw volume of the tubes, which could produce erroneous results for prothrombin time, activated partial thromboplastin time, and fibrinogen assays.
Implantable Pulse Generators - Product Usage: used to treat arrhythmias related to bradycardia. Additionally, CRT-P devices can also provide cardiac resynchronization therapy (CRT) in treatment of heart failure. 1. Azure family: Azure XT DR MRI SureScan", Azure S DR MRI SureScan, Azure XT SR MRI SureScan, Azure S SR MRI SureScan. 2. Astra family: Astra XT DR MRI SureScan, Astra XT SR MRI SureScan.
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
🏥 Medical Devices Class I - Dangerous
A longevity estimation error may occur in the early years of device life when a unipolar pacing vector is programmed in the right atrial (RA) lead and/or the right ventricular (RV) lead. No other device features or therapies are impacted.
CRT-P Quad Models (CRT-Ps): a. Percepta CRT-P MRI: W1TR01, W1TR04, W4TR01, W4TR04 b. Serena CRT-P MRI: W1TR02, W1TR05, W4TR02, W4TR05 c. Solara CRT-P MRI: W1TR03, W1TR06, W4TR03, W4TR06. implantable medical devices used to treat arrhythmias related to bradycardia, and cardiac resynchronization therapy (CRT)
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
🏥 Medical Devices Class I - Dangerous
There is a SmartSync software issue that results in an overestimation in the displayed longevity of these devices during an approximate 6-month window of time before the device triggers its Recommended Replacement Time (RRT).
Programmers - Product Usage: used to treat arrhythmias related to bradycardia. Additionally, CRT-P devices can also provide cardiac resynchronization therapy (CRT) in treatment of heart failure. 1. 2090 Carelink 2. 29901 Encore
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
🏥 Medical Devices Class I - Dangerous
A longevity estimation error may occur in the early years of device life when a unipolar pacing vector is programmed in the right atrial (RA) lead and/or the right ventricular (RV) lead. No other device features or therapies are impacted.
🏥 Medical Devices Class I - Dangerous
The firm received a complaint regarding particulate found in the packaging foam that could contaminate the sterile field.
🏥 Medical Devices Class I - Dangerous
During internal Age Testing, holes were found in the sterile Tyvek pouches of the devices.
Implantable cardiac resynchronization therapy pacemakers (CRT-P) - Product Usage: used to treat arrhythmias related to bradycardia. Additionally, CRT-P devices can also provide cardiac resynchronization therapy (CRT) in treatment of heart failure. 1. Percepta family: Percepta CRT-P MRI SureScan, Percepta Quad CRT-P MRI SureScan. 2. Serena family: Serena CRT-P MRI SureScan, Serena Quad CRT-P MRI SureScan. 3. Solara family: Solara CRT-P MRI SureScan, Solara Quad CRT-P MRI SureScan.
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
🏥 Medical Devices Class I - Dangerous
A longevity estimation error may occur in the early years of device life when a unipolar pacing vector is programmed in the right atrial (RA) lead and/or the right ventricular (RV) lead. No other device features or therapies are impacted.
🏥 Medical Devices Class I - Dangerous
During internal Age Testing, holes were found in the sterile Tyvek pouches of the devices.
🏥 Medical Devices Class I - Dangerous
When the Cross Enterprise Display option is enabled on the Centricity Universal Viewer and Workflow Manager option is used as the PACS worklist launching the viewer, the patient jacket may potentially include a different patient s comparison exam(s).
🏥 Medical Devices Class I - Dangerous
Incorrect size printed on the device; packaging is labeled correctly.
YTL, Longli and TIYA Log Splitters with Briggs & Stratton® 250cc engines
Briggs & Stratton, of Wauwatosa, Wis. (engine)
🏠 Consumer Products Class II - Moderate
An incorrect engine ignition coil and flywheel can lead to hard starting and engine kick back, posing an injury hazard to the operator.
Wild Republic Slap Watches
Unknown Manufacturer
🏠 Consumer Products Class II - Moderate
The coin cell battery inside the slap watches can fall out, posing battery ingestion and choking hazards to young children.
2021 CFORCE 800XC All-Terrain Vehicles (ATVs)
Unknown Manufacturer
🏠 Consumer Products Class II - Moderate
The electronic power steering (EPS) can malfunction and cause the rider to lose control of the vehicle, posing a crash hazard.
Kidde TruSense Smoke Alarms and Combination Smoke/Carbon Monoxide Alarms
Unknown Manufacturer
🏠 Consumer Products Class I - Dangerous
The smoke alarm and the combination smoke/carbon monoxide (CO) alarm can fail to alert consumers to a fire.
🍎 Food Class I - Dangerous
Undeclared anchovy allergen
🍎 Food Class I - Dangerous
Product potentially contains undeclared almonds.
vitafusion Melatonin 140ct, 3 Pack 140 CT vitafusion Melatonin 44ct , 3Pack 44CT
Church & Dwight Co., Inc. OGI Distribution Center
🍎 Food Class I - Dangerous
Potential presence of a metallic mesh material in products.
🍎 Food Class I - Dangerous
Dark Chocolate walnuts were packed in a container labeled at Dark Chocolate Espresso Beans and does not declare walnuts as an allergen Bottom label with nutritional information is correct for the Dark Chocolate Walnuts.