Pet food and pet product recalls

The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospital's technical room, resulting in Smoke and/or fire

The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospital's technical room, resulting in Smoke and/or fire

Salmonella typhimurium in organic basil

X-ray system C-arm may experience uncontrolled motion if 1) AC motor controller firmware has a faulty setting, 2) the Motor/gear assembly is worn, 3) CAT movement is driven at maximum speed and angulated more than 75 deg. from vertical, and 4) the emergency stop or touch guard is activated during the breaking sequence, which could lead to the C-arm hitting the patient or operator.

The steering caps, which are used to hold the handlebar in place, can crack and cause the handlebars to become unstable, posing a crash hazard.

When the recalled dog eyelid wipes are opened and in use, bacteria and fungi, which are organisms found widely in the environment, soil, and water, can be introduced and grow in the container, posing a risk of serious infection to people with weakened immune systems. Individuals with wounds may also be at higher risk of infection. People with healthy immune systems are not typically affected.

The recalled snowmobile's drive clutch can break, allowing fragments to escape the snowmobile shielding, posing a laceration hazard.

Due to complaints of particulates, residue, occlusions, and bent tips for sterile cannulas.

Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil.

The recalled area rugs violate the mandatory federal flammability regulations for carpets and rugs, posing a fire hazard.

Inadequate reprocessing validation evidence

The potential presence of a foreign metal object in the product, i.e. a stainless-steel ring.

The potential presence of a foreign metal object in the product, i.e. a stainless-steel ring.

The potential presence of a foreign metal object in the product, i.e. a stainless-steel ring.

The recalled children's pajamas violate the flammability regulations for children's sleepwear, posing a risk of burn injuries to children.

The brake line can come in contact with the brake disc, which can cause damage to the brake line and result in brake loss, posing an injury hazard.

Potential contamination of Listeria monocytogenes

The recalled children's pajama sets violate the flammability regulations for children's sleepwear, posing a risk of burn injuries to children.

Illegible Label

The biometric lock on the safes can fail and be opened by unauthorized users, posing a serious injury hazard and risk of death if the safe is used to store firearms.

The rugs violate the federal flammability regulations for carpets and rugs, posing a fire hazard.

Undeclared egg

The fishing game does not comply with the requirements of the mandatory federal toy regulation because it contains one or more magnets that fit within CPSC's small parts cylinder and the magnets are stronger than permitted. When high-powered magnets are swallowed, the ingested magnets can attract to each other, or another metal object, and become lodged in the digestive system. This can result in perforations, twisting and/or blockage of the intestines, infection, blood poisoning and death.

Undeclared Allergen - Coconut

Misbranding, Unreported Allergens

In affected products, the tubing outer diameter may vary in size or the length of tubing may be too short. Both issues may lead to false air-in-line alarms, which will stop the infusion and interrupt therapy. Interruptions or delays in medication administration may result in serious injury to patients which may be life-threatening (e.g. interruption of a vasopressor to a hemodynamically unstable patient) or may lead to death.

Contains Sodium Nitrite recalled for potential metal contamination

The vehicle can move when on an incline and "park" is displayed on the digital dash. This can allow the vehicle to roll away, posing a crash hazard.

The recalled loungers fail to meet the safety requirements of CPSC's Infant Sleep Products Rule, creating an unsafe sleeping environment for infants and posing a suffocation risk and fall and entrapment hazards to infants. The failures include not having a stand and not meeting the requirements for side height and fabric-sided openings. The product's sides are shorter than the minimum side height limit; the sleeping pad's thickness exceeds the maximum limit; and an infant could fall out of an enclosed opening at the foot of the lounger or become entrapped.

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.