– KinderFarms, LLC is voluntarily recalling all lots of KinderMed Infants’ Pain & Fever (oral suspension) and KinderMed Kids’ Pain & Fever (oral suspension) to the retail and consumer level. These products are being voluntarily recalled due to acetaminophen instability. The two products were manufa
Asensus Surgical Inc. is recalling the Senhance Surgical System, used in laparoscopic procedures, due to malfunctions and needing a software update.
The FDA is informing patients and health care providers that pulse oximeters have limitations and a risk of inaccuracy that must be considered.
The Novum IQ syringe pump, intended to be used for the controlled administration of fluids, is being recalled due to downstream occlusion false alarms.
Sanxin Single Use Syringes are used for hemodialysis treatments. They are recalled for blood or heparin solution leaking from the syringe.
Mumbai, Maharashtra, Kilitch Healthcare India Limited is voluntarily recalling the eye drops products listed in the table below to the consumer level with all lots within expiry with expiration dates ranging from November, 2023 to September, 2025 for all the below mentioned products. These products
Some Cardinal Health Monoject Luer-lock tip syringes have demonstrated recognition and compatibility issues with certain syringe infusion pumps.
Covidien LLC recalls McGRATH™ MAC Video Laryngoscope to remove stolen defective items being sold illegally by unauthorized third parties.
The safety and effectiveness of surgical mesh in breast surgery, including in augmentation and reconstruction of the breast, has not been determined by the FDA.
The Teleflex and Arrow International, Pressure Injectable Catheter Kits are being recalled for incorrect labeling of the product code and product name.
Nurse Assist, LLC initiated a voluntary recall of 0.9% sodium chloride irrigation USP and sterile water for irrigation USP, due to the potential for a lack of sterility assurance, which could result in a nonsterile product. In populations most at risk, such as patients who are immunocompromised, the
Nurse Assist, LLC announced a recall because the products may not be sterile. Patients are at risk of infection.
La Vergne, TN, The Harvard Drug Group, LLC d/b/a Major® Pharmaceutical and Rugby® Laboratories is initiating a voluntarily recall for all lots of Polyvinyl Alcohol, 1.4% Lubricating Eye Drops and Lubricating Tears Eye Drops (Dextran/Hypromellose, 0.1%/0.3%) supplied by Velocity Pharma, LLC to the co
Dublin, OH, Cardinal Health, Inc. is initiating a voluntarily recall for all lots of ophthalmic products supplied by Velocity Pharma, LLC to the consumer level. Cardinal Health, Inc. received information from FDA indicating investigators found insanitary conditions in the manufacturing facility and
The Olympus High Flow Insufflation Unit delivers carbon dioxide gas into the abdomen or colon. The unit may over-inflate air into the body with no warning.
Lenoir, North Carolina. Exela Pharma Sciences, LLC, (Exela) is voluntarily recalling the products listed in the table below to the consumer level. Particulate matter identified as silicone was observed during routine inspection of retain samples. Risk Statement: Administration of an injectable pro
The FDA is evaluating the potential risk of exposure to toxic compounds when using certain Fresenius Medical Care hemodialysis machines
Fresenius Medical Care 2008 Series Hemodialysis Machines are recalled for the potential for toxic compounds leaching from chlorinated peroxide cured silicone tubing.
The FDA expanded its evaluation of the potential risk of exposure to toxic compounds when using hemodialysis and peritoneal dialysis systems
Philips Respironics recalls V60 and V60 Plus Ventilators because the PM PCBAs do not conform with ventilators standards.