All Recalls

The Bodor i Series products fail to meet certain applicable Federal standards, 21 CFR 1040.10(f)(1) and 21 CFR 1040.10(f)(2).

Due to packaging discrepancy with the incorrect tibial inserts/implants being packaged. Issued discovered via a customer complaint.

The HSG Procedure Trays and Endosee System Convenience Kits contain non-sterile iodine pouches, however the peel away lid labels incorrectly identify the iodine pouches as sterile.

Bedside SpO2 Patient Monitoring System alarms not heard/recognized, resulting in: treatment delay, lack of low oxygen saturation response, respiratory failure, arrhythmia. Highlighting operator's manual: 1)For patient Safety don't silence/decrease alarm volume, 2)Sensor off alarm (no perfusion detected) is low priority alarm, 3)Set monitors to Homecare Mode outside of hospital/professional setting

Due to defects (bubbles/voids) identified during standard finished goods testing

GE HealthCare has become aware that gradient coils for certain MR systems (see affected product list in this letter), under specific conditions, can produce elevated acoustic noise during scanning. As a result, acoustic levels can exceed 99dB, the limit established by International Electrotechnical Commission (IEC 60601-2-33) when using hearing protection with a Noise Reduction Rating (NRR) of 29dB, as currently required in the Operator Manual.

Lens blisters may have an incomplete or leaking seal which may render them unsterile.

Due to complaints their is the potential that irrigation solution may leaked into the handpiece and battery pack causing it to malfunction.

Discrepancies between sterilization instructions in the Japanese language product package inserts and those published in the manufacturer product Instructions For Use (IFU).

The recalled dressers are unstable if they are not anchored to the wall, posing serious tip-over and entrapment hazards that can result in injuries or death to children. The dressers fail to meet the mandatory standard, as required by the STURDY Act.

The minifridges' internal electrical components can short circuit and ignite the surrounding plastic housing, posing fire and burn hazards.

The bottles contain turpentine, which must be in child-resistant packaging as required by the Poison Prevention Packaging Act. The packaging is not child-resistant, posing a risk of serious injury or death from poisoning if the contents are ingested by young children.

The e-bikes' lithium-ion battery can overheat and ignite, posing serious fire and burn hazards to consumers.

The rechargeable battery in the Electric Bug Zapper Racket, Fly Swatter, and Mosquito Swatter can catch fire when used for extended periods of time.

The battery compartment of the recalled light-up ruler bracelets can be opened easily by children, allowing access to the button cell batteries, violating the battery-operated toys requirements under the mandatory standard for toys. If a child swallows a button cell or coin battery, it can cause serious injuries, internal chemical burns or death.

The recalled LED gloves violate the mandatory standard for toys containing coin batteries because the compartment that holds the batteries can be easily accessed and opened by children. Additionally, the spare coin batteries provided with the toys are not in child-resistant packaging and do not have the warnings required under Reese's Law. When button cell or coin batteries are swallowed, the ingested batteries can cause serious injuries, internal chemical burns and death.

The recalled gates violate the mandatory standard for expansion gates and expandable enclosures because a child's torso can fit through the opening between the gate and the floor, posing a risk of serious injury or death due to entrapment.

The magnets on the inside cover can detach, posing an ingestion hazard to children. When high-powered magnets are swallowed, the ingested magnets can attract each other, or other metal objects, and become lodged in the digestive system. This can result in perforations, twisting and/or blockage of the intestines, infection, blood poisoning and death.