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 2, 3:52 PM ET · refreshed about every 2.5 hours · RSS · Get recall alerts
FDA drug and medical device recalls.
State filter: shows recalls whose official distribution lists that state, plus nationwide ones. CPSC and NHTSA recalls apply nationwide.
482 recalls
Medicines & devicesClass II
During use of an affected tube, the operator may encounter increased resistance when inserting the pipette. The resulting pressure buildup may cause the tube cap to detach or be forcibly ejected, potentially resulting in
· FDA · Nationwide
Medicines & devicesClass III
Subpotent Drug
· FDA · Nationwide
Medicines & devicesClass II
Presence of Foreign Tablets/Capsules
· FDA · Nationwide
Medicines & devicesClass II
Failed Impurities/Degradation Specifications: OOS result obtained for a process impurity, dicyclohexylurea (DCU).
· FDA · Nationwide
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
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
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
Medicines & devicesClass I
Presence of Particulate Matter: particulate matter identified as iron oxide, inorganic material, cellulose cotton fiber or polystyrene
· FDA · Nationwide
Medicines & devicesClass III
Labeling: Label Mix-up
· FDA · Nationwide
Medicines & devicesClass III
Failed Stability Specifications: Out of specification stability result for the protein concentration profile.
· FDA · MO, TN
Medicines & devicesClass II
Kits contain Microstream components. Medtronic issued an update to the Instructions for Use of these components due reports of difficulty in disconnecting the adapter from the patient's endotracheal tube to perform a pro
· FDA
Medicines & devicesClass II
Potential for detachment of ceramic tip due to manufacturing without the designated amount of adhesive.
· FDA · Nationwide
Medicines & devicesClass II
Potential for the inflation chart label affixed to the shaft of the device to be incorrect and indicate a balloon diameter of 18, 19, or 20 mm,
· FDA
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.