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, 4:59 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.
305 recalls for “AI”
Medicines & devicesClass II
Diagnostic electrophysiology (EP) catheter may have a breached sterile barrier on the straight seal side of the primary pouch, which if used could lead to particulate embolization, infection, thrombus or ganuloma formati
· FDA · Nationwide
Medicines & devicesClass II
Labeling updated warning not to use Intrapulmonary percussive ventilation (IPV) in conjunction with volatile anesthetic delivery systems because IPV may alter controlled delivery of volatile anesthetic agents, resulting
· FDA · Nationwide
Medicines & devicesClass II
The kits contain tube sets with handpieces that may leak during use. The impacted devices can have the following failures: fluid leakage from the hand piece that can pool on the floor. The impact can range from user diss
· FDA · Nationwide
Medicines & devicesClass II
Screws, intended for use with polyaxial compression plating system intended for foot osteotomies, was manufactured with missing threads on the screwheads, which if used would prevent a secure rigid engagement with the pl
· FDA · Nationwide
Medicines & devicesClass I
Presence of Particulate Matter: particulate matter identified as stainless steel particles in the solution.
· FDA · Nationwide
Medicines & devicesClass I
Presence of particulate matter: Particulates identified as fiberglass
· FDA
Medicines & devicesClass II
Failed Dissolution Specifications; product failed to meet 18-month stability testing acceptance criteria
· FDA · Nationwide
Medicines & devicesClass II
The potential for falsely elevated results.
· FDA · Nationwide
Medicines & devicesClass II
Failed Stability Specifications
· FDA · Nationwide
Medicines & devicesClass II
Failed Dissolution Specifications; product failed to meet 24-month stability testing acceptance criteria
· FDA · Nationwide
Medicines & devicesClass II
Potential for quality control failures with Klebsiella pneumoniae ATCC BAA-1705 when using the CPO Ambler classification feature.
· FDA · Nationwide
Medicines & devicesClass I
Presence of Particulate matter.
· FDA · Nationwide
Medicines & devicesClass II
Medtronic identified through donor record review that the donor for Medtronic batch A62881 did not meet all Medtronic donor eligibility requirements related to the presence of microbial organisms. While the batch passed
· FDA · Nationwide
Medicines & devicesClass II
The rinse-line check valve has a shorter service lifespan than originally expected and requires annual replacement to prevent lamina fluid leakage; however, the check valve replacement was excluded from the annual preven
· FDA · Nationwide
Medicines & devicesClass II
Due to potential contaiminated of spefic lots of pneumonia and joint infection panels that could result in false positive results
· FDA · Nationwide
Medicines & devicesClass II
Product failed to meet the specified acceptance criteria for Integral Water Permeability (IWP).
· FDA · Nationwide
Medicines & devicesClass I
The potential for purge cassette recognition issues due to the failure of the purge flag component of the purge pressure sensor assembly.
· FDA · Nationwide
Medicines & devicesClass II
There is a discrepancy between the product identification on the packaging and the dimensions of the implant contained inside.
· FDA · Nationwide
Medicines & devicesClass II
Positron emission tomography and computed tomography x-ray systems have a software problem when Split or Local function is enabled, and multiple RIS exams are merged into a single study, that prevents patient images from
· FDA · Nationwide
Medicines & devicesClass I
The kits contain certain lots of sterile applicators which may contain fungal contamination that may occur under certain environmental conditions, allowing the growth of Aspergillus penicillioides. Contamination of skin
· FDA · Nationwide
Medicines & devicesClass II
A software issue that may occur during a Volume/Time (VOT) multi-syringe infusion when a syringe reaches empty and is replaced while a Volume To Be Infused (VTBI) remains.
· FDA · Nationwide
Medicines & devicesClass I
Presence of particulate matter:An internal investigation at the firm found the product to contain glass particles.
· FDA · Nationwide
Medicines & devicesClass II
Kits contain manufacturer-recalled perineal care (pericare) wipes within urinary catheter trays, which may be contaminated with a lubricant used during the manufacturing process. Use of a contaminated wipe may lead to lo
· FDA · Nationwide
Medicines & devicesClass II
Kits contain Healthmark Instrument Channel Brushes, which were recalled by the manufacturer due to the potential for a sharp edge/burr on the end of the brush. Potential hazards associated include cut injury/abrasion and
· FDA · Nationwide
Medicines & devicesClass II
The kits contain neurological sponges with the potential for unexpected variability of endotoxin levels. Potentially elevated endotoxin levels may present health risks that could require medical intervention, such as neu
· FDA · Nationwide
Medicines & devicesClass II
The kits contain applicators that may exhibit an open or incomplete seal on the packaging of the applicator. Use of a potentially contaminated applicator could result in no patient harm or may lead to localized skin or s
· FDA · Nationwide
Medicines & devicesClass I
Potential for product quality and sterility issues regarding kits containing Sodium Chloride ampules subject to recall by Spectra Medical.
· FDA · IL, NC, VA, WY
Medicines & devicesClass I
this is a downstream recall of class I recall RES 98777
· FDA · 50 states
Medicines & devicesClass II
Heightened probability of blood leak from the connection between the Arterial Alpha Clip and the main line or pump segment. Leak during treatment may lead to blood loss and hypovolemia.
· FDA · Nationwide
Medicines & devicesClass II
Due to software issue with ultrasound system, doppler sample is displayed shallower than its actual measurement location, potentially causing inaccurate blood flow velocity measurements and misdiagnosis.
· 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.