All Recalls

Hematology analyzers configured with HGB photometers may result in erroneously high hemoglobin (HGB) results on samples with elevated white blood cell (WBC) counts.

Due to a faulty electrical connection between the speed control Dial and the wheelchair motor, their is a potential for lost of control of the device potentially resulting in minor or major injuries.

Labeling includes shelf life that has not been validated.

Labeling includes shelf life that has not been validated.

Foley catheter trays have incorrect inserts, user may think:1)Silicone, when it's natural rubber latex, or 2)Natural rubber latex with infection control coating, when it's silicone hydrogel with antimicrobial coating, or 3)Natural latex with infection control, when it's silicone hydrogel coated without antimicrobial coating, which may cause infection and/or local and/or systemic allergic reaction

VITROS Chemistry Products LAC Slides on VITROS XT 3400 and VITROS XT 7600 Systems are experiencing an increased occurrence of calibration failure related to lots from coating 0130 and above with Condition Code TH4-63J during calibration, causing the delay of lac test results and potentially impact patient management. The issue was identified by QuidelOrtho through an increase in customer complaints compared to the historical baseline with average failure rate of 1% for coating 0130 in 2025 while average of failure rate for other coating was 0.06% in 2025 and average of failure rate for all coatings is 0.03% for 2024.

Reverse Shoulder humeral liners have an articular surface position outside of the dimensional specification within the labeling.

Three failure modes have been identified: failure of the Heartstring Seal to load, failure of the Heartstring Seal to deploy into the aortotomy, and failure of the deployed Heartstring Seal to provide adequate hemostasis.

Lack of a 510(k) premarket clearance for the i-STAT CG8+, EG7+ and EG6+ cartridges to reflect updated sample type for potassium and ionized calcium and measurement ranges for pH and PO2.

The internal lithium-ion battery can overheat, produce smoke, and/or eject material, posing fire and burn hazards.

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

Alcohol fuel can splash or leak out of the fire pit reservoir during use and/or ignition, causing a flash fire that can spread and create larger hotter flames that can escape the unit, presenting risk of serious burn injury from flame jetting and fire hazards.

The misting fan can overheat while charging and ignite, posing a fire hazard.

The recalled baby loungers violate the mandatory standard for Infant Sleep Products. The sides are too low to contain an infant. The sleeping pad is too thick, posing a suffocation hazard. The enclosed openings at the foot of the loungers are wider than allowed, posing a fall hazard and an entrapment hazard to infants. Also, the baby loungers do not have a stand, posing a fall hazard if it is used on elevated surfaces. These violations create an unsafe sleeping environment for infants and can cause death or serious injury to infants. In addition, the recalled baby loungers come with crib bumpers, which are banned by the Federal Safe Sleep for Babies Act because the padded crib bumpers can obstruct breathing, posing a risk of serious injury or death to infants from suffocation.

The heating element can cause sugar to ignite, if a consumer uses the product without the included sugar receptacle, posing a fire hazard.

The recalled kids' helmets violate the mandatory safety standard for bicycle helmets because the helmets do not comply with the impact attenuation, positional stability, labeling and certification requirements. The helmets can fail to protect the user in the event of a crash, posing a serious risk of injury or death due to head injury.

The recalled toys violate the mandatory standard for toys containing button batteries because the compartment that holds the batteries in the remote can be accessed without the use of a common household tool. If button cell or coin batteries are swallowed, the ingested batteries can cause serious injuries, including internal chemical burns and death.

Potential for spoilage due to yeast contamination.

Products may be contaminated with Listeria monocytogenes

Product tested elevated coliform counts during routine testing