Medicines & devicesClass II
Neuronetics, Inc. recalls NeuroStar Advanced Therapy System
Cables are not in conformance with the product specifications required in the production of the HP Coil Assembly.
· FDA · Nationwide
Safety recalls that rarely make the news, straight from the official U.S. agency records (FDA, USDA, CPSC, NHTSA). Every listing links to its official notice. We only copy what the record says.
Checked Nov 3, 1:24 AM ET · refreshed about every 2.5 hours · RSS · Get recall alerts
State filter: shows recalls whose official distribution lists that state, plus nationwide ones. CPSC and NHTSA recalls apply nationwide.
1105 recalls
Medicines & devicesClass II
Cables are not in conformance with the product specifications required in the production of the HP Coil Assembly.
· FDA · Nationwide
Medicines & devicesClass II
Lack of 510(k) clearance.
· FDA · Nationwide
Medicines & devicesClass II
Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5 years.
· FDA · Nationwide
Medicines & devicesClass II
There are identified discrepancies between the sterilization parameters listed in the Instructions for Use and the sterilization parameters listed in the Japanese package insert.
· FDA
Medicines & devicesClass I
Tip may fracture or detach, leading to device fragments remaining within the patient or migrating through the vasculature. Patient impact may include prolonged procedure or life-threatening embolism.
· FDA · Nationwide
Vehicles & car seats
A damaged subframe my lead to a loss of steering control, increasing the risk of a crash.
· NHTSA · Nationwide
Vehicles & car seats
A seat belt anchor with a missing connector plate may fail to properly restrain the driver and insufficient joint strength may not adequately protect passengers, increasing the risk of injury in a crash.
· NHTSA · Nationwide
FoodClass I
Potential E. coli and Salmonella contamination
· FDA · 17 states
FoodClass I
Sprouts may be contaminated with STEC E. coli and/or Salmonella.
· FDA · MN, WI
Medicines & devicesClass I
Superpotent Drug
· FDA · Nationwide
Medicines & devicesClass II
CGMP Deviations: Potential contamination of raw material
· FDA · CO
Medicines & devicesClass II
Failed Dissolution Specifications. Notification from the manufacturer that lot is being recalled due to failed dissolution
· FDA · Nationwide
Medicines & devicesClass II
The pelvic fixation screws failed to meet acceptance criteria for tube packaging seal integrity testing; therefore, sterility assurance cannot be ensured.
· FDA · Nationwide
Medicines & devicesClass II
Software issues may affect the safety and performance of Spectral CT system(s). The issues may result in image artifacts, wrong slice thickness, or unintended system motion.
· FDA · Nationwide
Medicines & devicesClass II
A performance issue may result in inaccurate blood pressure readings when the Linear Deflation Method is used.
· FDA · Nationwide
Medicines & devicesClass II
A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction requirements exceed the available system memory.
· FDA · Nationwide
Vehicles & car seats
A child in the front seat may be at a greater risk of injury if the air bag deploys during a crash.
· NHTSA · Nationwide
Vehicles & car seats
A short circuit increases the risk of a fire.
· NHTSA · Nationwide
Vehicles & car seats
Instability while towing increases the risk of a crash.
· NHTSA · Nationwide
Vehicles & car seats
An improperly calibrated system may have a delayed braking response, increasing the risk of a crash.
· NHTSA · Nationwide
Medicines & devicesClass II
Robotic system square drive failed to meet design specifications potentially resulting in pin becoming stuck in square driver or the pin wobbling during drilling.
· FDA · Nationwide
FoodClass II
Product may contain undeclared sugar.
· FDA · UT
Medicines & devicesClass II
Lack of Assurance of Sterility
· FDA · Nationwide
Medicines & devicesClass II
Some MiniMed Flex insulin pumps were released with missing (i.e., devices with no result or abort test results are presumed to have failed) or failed verification test results in one or more of 9 functional tests. The un
· FDA · Nationwide
Medicines & devicesClass II
hCG rapid tests may detect low levels of hCG below the stated assay sensitivity, which may result in false positive result.
· FDA · Nationwide
Medicines & devicesClass II
Breast biopsy and tissue removal system may experience the following errors: 1) Probe calibration and /or handheld driver failure (code HH01-00020009) , 2) Pressure sensor (code E01-0054000E), which prompts the user to r
· FDA · Nationwide
Medicines & devicesClass II
Potential for monomer liquid leakage.
· FDA · Nationwide
Medicines & devicesClass II
Myocardial temperature probes contain an incorrect needle. Specifically, an 18mm needle was included instead of a 15mm needle.
· FDA · Nationwide
Medicines & devicesClass II
Due to issue with endoscope adherence and inability to spray powder. Firm will provide an updated Instruction for Use (IFU).
· FDA · Nationwide
Medicines & devicesClass II
Reservoirs may exhibit medication leakage at the joint between luer connector and tubing. Issue could result in delay or interruption of therapy, under delivery of medication, exposure to infectious or toxic agents, or a
· FDA · Nationwide
Recall data comes from official U.S. government sources: openFDA (food, drugs, devices), USDA FSIS (meat, poultry, egg products), CPSC (consumer and children’s products) and NHTSA (vehicles, equipment, car seats). openFDA notes its data should not be relied on for medical decisions. Always confirm with the official notice. Check your vehicle by VIN at nhtsa.gov/recalls.