Montana recalls

Product Contamination

The FDA has issued an Advisory without batch numbers or expiration dates. At the request of the FDA, RAW FARM is issuing a Voluntary Recall of the batches of cheese below and any batches produced prior to these dates.

The canopy beams of the bed frames can collapse primarily when the bed is moved, posing impact and injury hazards to consumers.

The hair serum contains minoxidil, which must be in child-resistant packaging as required by the Poison Prevention Packaging Act. The hair serum's packaging is not child-resistant, posing a risk of serious injury or death from poisoning if the contents are swallowed by young children.

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

The chargers can ignite or cause a connected battery to ignite, posing a fire hazard and risk of serious injury and death.

The recalled bed rails violate the mandatory standard for adult portable bed rails because users can become entrapped within the bed rail or between the bed rail and the side of the mattress, posing a serious entrapment hazard and risk of death by asphyxiation. In addition, the bed rails do not bear the required warning labels.

The metal cap on the screw that connects the sauté pan to the handle can become detached and forcefully eject when heated, posing impact and burn hazards to consumers.

The hair and beard growth serum contains minoxidil, which must be in child-resistant packaging, as required by the Poison Prevention Packaging Act. The bottles are not child-resistant, posing a risk of serious injury or death from poisoning if the contents are swallowed by young children.

The recalled bed rails violate the mandatory standard for adult portable bed rails because when the bed rails are attached to a bed, users can become entrapped within the bed rail or between the bed rail and the side of the mattress, posing a serious entrapment hazard and risk of death by asphyxiation. In addition, the bed rails do not bear the required hazard warning labels.

The carabiner's gate can malfunction where the gate does not close automatically and has to be closed manually by hand, posing a risk of serious injury or death due to falling.

The recalled light-up rings violate the mandatory safety standard for toys because the battery compartment within the LED light ring contains button cell batteries that can be easily accessed by children. When button cell or coin batteries are swallowed, the ingested batteries can cause serious injuries, internal chemical burns and death.

The recalled light-up rings violate the mandatory safety standard for toys because the battery compartment within the LED light ring contains button cell batteries that can be easily accessed by children. When button cell or coin batteries are swallowed, the ingested batteries can cause serious injuries, internal chemical burns and death.

The recalled spiral tower toy sets violate the mandatory standard for toys because they contain small balls and are intended for children under three years of age, posing a deadly choking hazard.

Elevated endotoxin levels identified in affected lots. Issue may elicit strong inflammatory response if used, including local tissue irritation, delayed wound healing, or systemic effects such as fever and hypotension. In severe cases, septic shock may result.

Due to product labeling not indicating which Transport Layer Security (TLS) version that must be enabled on hospital network to ensure secure Wi-Fi communication with Point-of-Care Units

Olympus identified that the Cutting Forceps contain components for which the supplier did not adequately validate the welding process. Defective welds can result in the Cutting Forceps' jaw breaking during clinical use.

Olympus identified that the Cutting Forceps contain components for which the supplier did not adequately validate the welding process. Defective welds can result in the Cutting Forceps' jaw breaking during clinical use.

Olympus identified that the Cutting Forceps contain components for which the supplier did not adequately validate the welding process. Defective welds can result in the Cutting Forceps' jaw breaking during clinical use.

Olympus identified that the Cutting Forceps contain components for which the supplier did not adequately validate the welding process. Defective welds can result in the Cutting Forceps' jaw breaking during clinical use.

Olympus identified that the Cutting Forceps contain components for which the supplier did not adequately validate the welding process. Defective welds can result in the Cutting Forceps' jaw breaking during clinical use.

Olympus identified that the Cutting Forceps contain components for which the supplier did not adequately validate the welding process. Defective welds can result in the Cutting Forceps' jaw breaking during clinical use.

Olympus identified that the Cutting Forceps contain components for which the supplier did not adequately validate the welding process. Defective welds can result in the Cutting Forceps' jaw breaking during clinical use.

The Czech language user guide contained multiple translation errors. The most significant error was that it incorrectly instructs users to verify that the infusion set is connected to the body, when it should instead direct users to confirm that the infusion set is not connected to the body. Following this instruction could result in unintended insulin delivery, potentially leading to a hypoglycemic event.

Three software defects (Pump Error 53, BG check, and Critical Pump Error (Open Book Image)) that occurred as a result of software updates (versions 6.60, 6.61, and 6.62), which could result in a risk of hypoglycemia or hyperglycemia due to inaccuracies in insulin delivery (either under-delivery, over-delivery, or cessation of delivery).

Due to identifying a limited quantity of intraocular lenses that may have a haptic that sticks to the optic which prevents the lens from unfolding as consistently as expected.

A material mix-up had occurred during the manufacturing of Straumann¿ Custom Abutments. More specifically, a raw material bar of TAN-material (SAP #701924 / Lot 7130439) was incorrectly identified as a Titanium Bar Ti Gr4 D (SAP #701922 / Lot 7130430). As a result, RC Titanium abutments were manufactured using the TAN Bar material on Mill-from-Bar Machine 396-06.

A material mix-up had occurred during the manufacturing of Straumann¿ Custom Abutments. More specifically, a raw material bar of TAN-material (SAP #701924 / Lot 7130439) was incorrectly identified as a Titanium Bar Ti Gr4 D (SAP #701922 / Lot 7130430). As a result, RC Titanium abutments were manufactured using the TAN Bar material on Mill-from-Bar Machine 396-06.

Product labeling includes a fetal indication for use that is not cleared under its 510(k).

Drill plates manufactured out of specification can result in a bone cut in excess 00800"(2.8448mm)