Medicines & devicesClass III
Macleods Pharmaceuticals Limited recalls Olanzapine Tablets
Failed Impurities/Degradation Specifications:Organic and unspecified impurities above specification.
· FDA · Nationwide
Recalls
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.
305 recalls for “AI”
Medicines & devicesClass II
Mylan Pharmaceuticals Inc recalls Carton label: Mycophenolate Mofetil for injection
Failed Dissolution Specifications
· FDA · Nationwide
Medicines & devicesClass II
GRI Medical & Electronic Technology Co., Ltd. recalls HALYARD Laparoscopy Comprehensive Pack II REF: 49332
Laparoscopy packs labeled as "latex free" were found to contain a latex urethral catheter
· FDA · Nationwide
Medicines & devicesClass III
Ajanta Pharma USA Inc recalls Fluphenazine Hydrochloride Tablets
Failed impurities/degradation specifications: (OOS) for Organic Impurities by HPLC (Impurity-A) during testing at the 18 months long term stability. Result: 1.1 percent. Spec: 1.0 percent.
· FDA · Nationwide
Medicines & devicesClass III
ImprimisRx NJ LLC recalls Povidone Iodine 1
Subpotent Drug
· FDA · Nationwide
Medicines & devicesClass II
Hikma Pharmaceuticals USA INC. recalls Ramipril Capsules USP
Failed Impurities/Degradation Specifications: OOS result obtained for a process impurity, dicyclohexylurea (DCU).
· FDA · Nationwide
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
Medicines & devicesClass II
ASP Global, LLC. recalls 64 products
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 I
Boston Scientific Corporation recalls Imager II Angiographic Catheters M001314001 IMAGER II/5/ST/65/038 BX5
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
VITRUVIAS THERAPEUTICS INC recalls Thyroid Tablets
Superpotent Drug
· FDA · Nationwide
Medicines & devicesClass II
Lexia LLC recalls 2 products
CGMP Deviations: Potential contamination of raw material
· FDA · CO
Medicines & devicesClass II
Golden State Medical Supply Inc. recalls Prasugrel HCI
Failed Dissolution Specifications. Notification from the manufacturer that lot is being recalled due to failed dissolution
· FDA · Nationwide
Medicines & devicesClass II
SI-BONE, Inc. recalls iFuse TORQ Implant System Model/Catalog Number: 10055T(10x55mm)
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
PHILIPS MEDICAL SYSTEMS recalls Spectral CT and Spectral CT 7500 RT
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
Philips North America Llc recalls 12 products
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
Medtronic MiniMed, Inc. recalls Brand Name: MiniMed Flex Product Name: MiniMed Flex Insulin Pump Model/Catalog Numbers: MMT-8062
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
Alere San Diego, Inc. recalls 4 products
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
Bard Peripheral Vascular Inc recalls EnCor EnCompass Breast Biopsy and Tissue Removal System Console (model number: ENCPCONSOLE) and Driver (model
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
Heraeus Medical GmbH (Dental Division) recalls 4 products
Potential for monomer liquid leakage.
· FDA · Nationwide
Medicines & devicesClass II
DeRoyal Industries Inc recalls REF: 81-030415 Myocardial Probe Non-Pyrogenic
Myocardial temperature probes contain an incorrect needle. Specifically, an 18mm needle was included instead of a 15mm needle.
· FDA · Nationwide
Medicines & devicesClass II
Wilson-Cook Medical Inc. recalls Brand Name: HEMOSPRAY ENDOSCOPIC HEMOSTAT Product Name: HEMOSPRAY ENDOSCOPIC HEMOSTAT Model/Catalog Number: HE
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
ICU Medical, Inc. recalls CADD Yellow Medication Cassette Reservoir with NRFit connector US Product Codes: 21-7600-24
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
B BRAUN MEDICAL INC recalls 0
Presence of Particulate Matter: particulate matter identified as iron oxide, inorganic material, cellulose cotton fiber or polystyrene
· FDA · Nationwide
Medicines & devicesClass III
Chiesi USA, Inc. recalls Revcovi (elapegademase-lvlr) Injection
Failed Stability Specifications: Out of specification stability result for the protein concentration profile.
· FDA · MO, TN
Medicines & devicesClass II
Cardinal Health 200, LLC recalls Presource Packs containing Medtronic Microstream Components: Intubation Kit Catalog Numbers AN23366084 AN23366
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
Stryker Sustainability Solutions recalls 6 products
Reusable access port system may crack or seperate during use.
· FDA · Nationwide
Medicines & devicesClass II
NOXBOX LTD recalls NOxBOXi Nitric Oxide Delivery System
Potential for oxygen tubing leaks due to failure of the tubing or tubing connection, which may lead to oxygen desaturation.
· FDA · Nationwide
Medicines & devicesClass I
BD SWITZERLAND SARL recalls BD Alaris Pump Infusion Sets 10561554* 10885403232565 50885403232563 BD Alaris Pump Infusion Set
Due to discrepancies in specific attributes in the performance data for infusion sets, which may lead to inappropriate pump performance.
· FDA · 53 states
Medicines & devicesClass II
Radiometer Medical ApS recalls The ABL90 FLEX and ABL90 FLEX PLUS analyzers are intended for use by trained technologists
In vitro diagnostic analyzer had a risk of potentially inaccurate results requiring changes to instructions for use and: 1) Sample types, including whole blood samples no longer suitable for testing FHbF and ctBil, 2) Re
· FDA · Nationwide
Medicines & devicesClass II
Cadwell Industries Inc recalls Brand Name: IOMAX Product Name: IOMAX Cortical Module Model/Catalog Number: 190296-200 UDI-DI code: 0084006710
Stimulator device contains a defective printed circuit board assembly (PCBA) that may cause the device to unintentionally deliver electrical stimulation to the patient, or allow an unintended electrical current to reach
· 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.