Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Alcohol Test Strip, DiagnosUS¿ SARS-CoV-2 Antibody (IgG/IgM) Test, HealthyWiser KetoFast" Ketone Test Strips and PrestiBio" Ketone Test Strips without marketing authorization. UMI is also recall their tests because they are going out of business and would not be able to continue fulfilling any post-market responsibilities of these distributed products. UMI claims to hold 510(k)s for the other devices, purchased the intellectual property in 2015 from the previous 510(k) holder, but FDA has been unable to verify this information. The devices may have unknown performance characteristics because the firm is unable to provide any documentation that the devices were manufactured in conformance with the Quality System regulation, including documentation (e.g., DHF) that the distributed devices had not been modified since original clearance in a way that could impact their safety and effectiveness, documentation of controlled storage temperature/humidity, and post-market surveillance documentation, such as complaints and adverse events.
Specific serial numbers of GraftonTM DBM product due to the potential that a step during the inspection of the outer Tyvek pouch may not have been performed according to requirements. Based on this, batches may have been released with potential non-conformances in the outer Tyvek pouch.
The pressure cooker has incorrect volume markings on the inner pot. This can cause consumers to overfill the pot and hot food and liquids to be ejected when the pressure cooker is vented using the quick release method or opened while its contents are pressurized, posing a burn hazard to consumers.
Doosan Bobcat North America, of West Fargo, North Dakota
🏠 Consumer Products Class III - Low Risk
The dampers installed on the steering system of the mower can prevent the control levers from returning to the neutral position and the Operator Presence switch will not activate and stop the engine and blades, posing crash and laceration hazards to the operator or bystanders.
Kawasaki Motors Manufacturing Corp. U.S.A., of Maryville, Missouri
🏠 Consumer Products Class I - Dangerous
The fuel tube could have been damaged due to improper workmanship while removing the fuel tube for repair, which could cause a fuel leak, posing fire and burn hazards.
Safeway Fresh Foods of Vineland, NJ, is recalling its 32-oz. Diced Organic Butternut Squash product as it has the potential to be contaminated with Escherichia coli O45. The 32-oz. diced Butternut was distributed only to Costco in the following states, Washington DC, Maryland, Pennsylvania, and Virgnia.
Plastic fragment. Product is recalled due to potential for a thin strip of the primary packaging film to remain adhered to the cheese slice after the wrapper has been removed.