Medicines & devicesClass II
SEASPINE ORTHOPEDICS CORPORATION recalls SeaSpine Mariner Deformity Product Name: Extended Polyaxial Head
The proximal thread depth of the spinal device is out of design 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, 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.
482 recalls
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
Sage Products, LLC recalls 2% Chlorhexidine Gluconate* Cloth
Cross Contamination with Other Products
· FDA · Nationwide
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
Medicines & devicesClass II
Stryker Sustainability Solutions recalls BARD EP XT DECAPOLAR STEERABLE
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
Percussionaire Corporation recalls 7 products
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
Cardinal Health 200, LLC recalls 4 products
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
Philips North America Llc recalls Philips Medical Systems Technologies Ltd
The Bolus tracking scan application may crash with a system error message. Bolus Tracker shots may continue to occur even if the contrast threshold is reached. This may result in the patient receiving additional radiatio
· FDA
Medicines & devicesClass II
Wright Medical Technology, Inc. recalls CHARLOTTE CLAW Screw
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 II
Baxter Healthcare Corporation recalls 3 products
There is an error in the product description on the Unique Device Identification (UDI) label. These discrepancies in labeling do not align with the approved product or product specifications and may lead to incorrect pro
· FDA · Nationwide
Medicines & devicesClass II
Olympus Corporation of the Americas recalls POWERSEAL 5 MM (in diameter) 23 CM (long)
Potential labeling deficiency in which an outer shelf box is incorrectly labeled as a 37-cm device.
· FDA · Nationwide
Medicines & devicesClass I
Baxter Healthcare Corporation recalls Dextrose Injection
Presence of Particulate Matter: particulate matter identified as stainless steel particles in the solution.
· FDA · Nationwide
Medicines & devicesClass I
Baxter Healthcare Corporation recalls 0
Presence of particulate matter: Particulates identified as fiberglass
· FDA
Medicines & devicesClass II
Mylan Pharmaceuticals Inc recalls Prasugrel Tablets
Failed Dissolution Specifications; product failed to meet 18-month stability testing acceptance criteria
· FDA · Nationwide
Medicines & devicesClass II
Microgenics Corporation recalls MAS Omni IMMUNE PRO Liquid Assayed Integrated Immunoassay Control
Vial-to-vial variability in MAS¿ Omni"IMMUNE PRO Liquid Assayed Integrated Immunoassay Control, Level 1, Lot OPRO29061A results in low Parathyroid Hormone (PTH) recovery, which may lead to a delay in reporting patient PT
· FDA · Nationwide
Medicines & devicesClass II
Siemens Healthcare Diagnostics, Inc. recalls Atellica CH Revised C-Reactive Protein (RCRP)
The potential for falsely elevated results.
· FDA · Nationwide
Medicines & devicesClass II
Allies Group Inc. recalls 4 products
Subpotent Product: Firm Testing indicated the affected product may not reliably provide the SPF 50 protection stated on the label.
· FDA · Nationwide
Medicines & devicesClass II
Medline Industries, LP recalls 2 products
The front fork stem bolt/wheel assembly may disconnect from the rollator frame tubing. If the front fork stem bolt/wheel assembly disconnects from the rollator frame tubing, the front wheels may become loose or detach fr
· FDA · Nationwide
Medicines & devicesClass I
Medline Industries, LP recalls 2 products
Potential fire hazard involving the hand control pendant and associated wiring used with affected beds. Pendant or pendant wiring may overheat, potentially leading to smoking, sparking, melting, burning, or fire. Additio
· FDA · Nationwide
Medicines & devicesClass II
American Nitrile Operations Llc recalls 3 products
Gloves may exhibit defects such as tears, missing fingers, and debris. Use of defective gloves may lead to healthcare personnel and patient exposure to infectious pathogens leading to infection or cross-contamination, or
· FDA · Nationwide
Medicines & devicesClass II
Safecor Health, LLC recalls 6 products
Failed Stability Specifications
· FDA · Nationwide
Medicines & devicesClass II
Apotex Corp. recalls Paxil CR
Failed Dissolution Specifications; product failed to meet 24-month stability testing acceptance criteria
· FDA · Nationwide
Medicines & devicesClass II
Becton Dickinson & Co. recalls 2 products
Potential for quality control failures with Klebsiella pneumoniae ATCC BAA-1705 when using the CPO Ambler classification feature.
· FDA · Nationwide
Medicines & devicesClass I
B BRAUN MEDICAL INC recalls Lactated Ringer's Injection USP
Presence of Particulate matter.
· FDA · Nationwide
Medicines & devicesClass II
Medtronic Sofamor Danek USA Inc recalls 2 products
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
Beckman Coulter, Inc. recalls 2 products
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
BioFire Diagnostics, LLC recalls 3 products
Due to potential contaiminated of spefic lots of pneumonia and joint infection panels that could result in false positive results
· 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.