Pet food and pet product recalls

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.

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.

The activity centers' straps can detach or break while a child is in the activity center, posing fall and injury hazards to the child.

Microbial Contamination of Non-Sterile Products: identified as Bacillus cereus.

Packs contain recalled components (equipment drapes, table cover, and surgical room turnover (SRT) kits).

The recalled pet products can contain bacteria, including Pseudomonas aeruginosa, an environmental organism found widely in soil and water. People with weakened immune systems or external medical devices who are exposed to Pseudomonas aeruginosa face a risk of serious infection that may require medical treatment. The bacteria can enter the body if inhaled, through the eyes, or through a break in the skin. People with healthy immune systems are usually not affected by the bacteria.

The passenger side seat belt buckle bracket was not properly welded, which could result in the seat belt anchor point separating from the frame, posing an injury hazard to consumers.

The plastic binding rings can detach from the books, posing a choking hazard to young children.

There is potential for discrepant high glucose results in samples with glucose results on the lower end of the reportable range.

Perishable products were not held at an appropriate temperature.