A mechanical defect on a printed circuit board (PCB) as a result of PCB separating process. This defect might cause the ventilator to either fail at startup (no patient involvement) or during the use of the device enter ambient state, resulting in an interruption of ventilation.
All Recalls
92,900 total recalls in our database
VITROS Chemistry Products Ca Slides; Catalog Number: 145 0261;
Ortho-Clinical Diagnostics
Generations 67 and above of VITROS Ca Slides are experiencing an increased occurrence of Condition Code TH4-63J during calibration on VITROS XT 3400 and VITROS XT 7600 Systems, causing calibration failures that delay calcium test results and potentially impact patient management. The imaging reflectometer algorithm detects excessive "spikes" (imperfections) in slide images and generates the TH4-63J condition code when the threshold of 600 spikes is exceeded. Updated analysis revealed a 19-fold increase in failure rates from 0.0043% (2024 baseline) to 0.082% for Generation 67+ slides in 2025, with 100% of calibrator failures occurring at the lowest concentration level. This can result in delayed diagnosis and treatment of conditions such as hypercalcemic crisis, parathyroid disorders, and other calcium-related emergencies requiring urgent intervention.
Affected lead models may experience gradually rising LVSI measurements in association with calcification of the defibrillation lead coils. The issue may lead to early lead replacement. Most serious harm is death or need for cardiac resuscitation.
Dynex Agility Sample Tips; Model Number: 67910; The 67910 Agility Sample Tips are an accessory/consumable used with the Agility Automated ELISA system.
Dynex Technologies
The internal label affixed to the sample tip rack is incorrectly labeled as reagent tip racks. When scanned by the Agility instrument, the tip rack is misidentified as a different tip type, rendering it incompatible with the system and preventing use which causes a delay in obtaining patient results.
Estrone RIA kit lots may rarely give falsely high patient results which might cause Temporary injury of Remote probability or rarely give falsely low patient results which might cause Permanent injury of Remote probability. Only in some (very rare) cases may the issue occur.
CX Series Combi Boiler
Unknown Manufacturer
A combi (or combination) boiler is a type of gas boiler that provides both a home's hot water and central heating. The hot water can exceed the temperature set on the control panel, posing a burn hazard to users.
Product label includes the ingredient CREAM but does not include Milk as the source.
Tuna Salad products are recalled due to potential contamination with Listeria monocytogenes because products containing Newly Weds Foods recalled Japanese Style Breadcrumbs.
FG60002 Cucumber Mint Lemonade - point of service product
AND GO CONCEPTS
The firm manufactured and distributed to retailers unpasteurized juice products in violation of 21 CFR 120 Juice HACCP regulations
Product label includes the ingredient CREAM but does not include Milk as the source.
READY MEALS DUO TUNA SALAD W/ CRACKERS
Albertsons Companies
Potential contamination with Listeria monocytogenes.
Lithium Orotate, 5MG, Distributed by Enjoy Nutrition, LLC. UPC#: 702730893968, 702730894064
Enjoy Nutrition, LLC;
Under potency / misbranding: product fails to meet labeled lithium orotate potency. (Downstream recall) from supplier of ingredient.
Tuna Salad products are recalled due to potential contamination with Listeria monocytogenes because products containing Newly Weds Foods recalled Japanese Style Breadcrumbs.
READY MEALS TUNA SALAD CROISSANT SANDWICH
Albertsons Companies
Potential contamination with Listeria monocytogenes.
READY MEALS TUNA SALAD SNACKER TRAY
Albertsons Companies
Potential contamination with Listeria monocytogenes.
Product label includes the ingredient CREAM but does not include Milk as the source.
Jewel Osco CLUB SANDWICHES WITH SALAD
Albertsons Companies
Potential contamination with Listeria monocytogenes.
Sukhi's, TIKKA MASALA INDIAN CURRY SAUCE, NET WT 3 OZ., UPC 7-67226-00163-0, DISTRIBUTED BY: SUKHI'S GOURMET INDIAN FOODS 25823 CLAWITER ROAD, HAYWARD, CA 94545 USA
Jagpreet Enterprises, LLC.
Potential contamination with foreign objects (metal pieces).
Product was manufactured and held under insanitary conditions. Product may be contaminated with Listeria monocytogenes.
Product label includes the ingredient CREAM but does not include Milk as the source.