Baby and kids' product recalls

Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in pressure monitoring, or an inability to zero the device due to either a leak within the TranStar Disposable Pressure Transducer or from a defect within the TranStar Disposable Pressure Transducer chip.

The term Bladder Stone was incorrectly translated in both Spanish and Portuguese to Kidney Stone(Clculo renal) on the systems Graphical User Interface (GUI), a potential to deliver an incorrect or unintended amount of energy to the patients anatomy.

The term Bladder Stone was incorrectly translated in both Spanish and Portuguese to Kidney Stone(Clculo renal) on the systems Graphical User Interface (GUI), a potential to deliver an incorrect or unintended amount of energy to the patients anatomy.

The recalled ATVs fail to comply with the requirements of the federal mandatory ATV safety regulations. The youth ATVs' mechanical suspension fails to comply with safety requirements, posing a crash hazard. The adult ATVs' service brakes fail to sufficiently stop the vehicle, posing a crash hazard, and the handlebars pose a laceration hazard if the adult rider's body or head impacts the handlebars. ATVs that fail to meet the mandatory safety regulations pose a risk of serious injury or death.

Beckman Coulter has become aware of an increase in customer complaints for intermittent IRISpec CB negative glucose control failure, resulting in false positive control results when used in conjunction with iChemVELOCITY Urine Chemistry Strips (PNs 800-7204 and 800-7212) on the iChemVELOCITY Analyzer. This issue may delay the reporting of patient results, with a worst-case scenario of a delay in diagnosis or treatment of metabolic disorders, kidney function abnormalities, urinary tract infections, and liver function.

Product is labeled as electrolytes but is actually caffeine

The recalled lighters do not have child-resistant mechanisms and were not tested to the federal regulatory requirements for child resistance. Young children under 5 years of age could ignite the lighters, posing fire and burn hazards.

The swing should never be used for sleep and bedding materials should never be added to it. If the product is used for sleep or bedding material is added, the headrest and body support insert on the seat pad can increase the risk of suffocation.

The recalled playpens violate the federal safety regulations for play yards. The included basketball hoop accessory can be a head entrapment hazard and children can become entrapped beneath the mattress, posing a suffocation hazard.

The recalled helmets do not comply with the positional stability, retention system, impact, labeling and certification requirements of the mandatory federal safety regulations for bicycle helmets. The helmets can fail to protect the wearer in the event of a crash, posing a risk of head injury.

The recalled youth ATVs fail to comply with the requirements of the federal mandatory ATV regulations. The handlebars pose a laceration hazard if the child rider's body or head impacts the handlebars at a high rate of speed. ATVs that fail to meet the mandatory safety requirements pose a risk of serious injury or death.

The reason for this recall is Healgen Scientific Ltd. has determined that their Urinary Reagent Strip products have shown reduced sensitivity, or potential false negative results for the detection of urinary protein by way of uneven color fading on the total protein test pad. This could lead to a delay in the identification of potential kidney diseases, their evaluation, and/or other conditions associated with elevated protein levels in urine and subsequently a delay in patient treatment.

Due to a software issue, affected devices that are set up with High Pressure Oxygen (HPO), if the flow alignment alarm occurs, the device will deliver room air only. If this happens, a patient my experience oxygen desaturation that could lead to hypoxia.

Due to possible packaging damage (indentations/cuts) cause by manufacturing process. As a result of the packaging damage, may cause the sterile barrier to be compromised.

GE HealthCare has become aware that complete electrical safety testing was not conducted during manufacturing of certain Giraffe and Panda iRes Warmers. There are multiple electrical safety protections included in the product design. However, because the electrical safety testing in manufacturing was incomplete for these devices, there is the potential for leakage current to exceed IEC 60601 limits.

GE HealthCare has become aware that complete electrical safety testing was not conducted during manufacturing of certain Giraffe and Panda iRes Warmers. There are multiple electrical safety protections included in the product design. However, because the electrical safety testing in manufacturing was incomplete for these devices, there is the potential for leakage current to exceed IEC 60601 limits.

Smith & Nephew, Inc., has initiated a field action to voluntarily remove two batches of K-Wires due to a packaging error. A complaint was received indicating that a package contained K-WIRE .062X9 2PT DM wires instead of K-WIRE .045X9 2PT DM as described on the product label.

Smith & Nephew, Inc., has initiated a field action to voluntarily remove two batches of K-Wires due to a packaging error. A complaint was received indicating that a package contained K-WIRE .062X9 2PT DM wires instead of K-WIRE .045X9 2PT DM as described on the product label.

The recalled Baby Tummy Time Gallery art card pockets have clear plastic coverings that contain levels of a phthalate that exceeds the federal phthalates ban. Phthalates are toxic if ingested by young children and can cause adverse health effects.

The rings contain levels of lead that exceed the federal lead content ban and levels of cadmium that are prohibited in children's products by the Federal Hazardous Substances Act. Lead and cadmium are toxic if ingested by young children and can cause adverse health effects.

During positioning within the system's 3D to 3D matching mode while transferring CBCT images, when the Float Image Selection button is pressed, it may display CBCT images that are insufficient in number.

During positioning within the system's 3D to 3D matching mode while transferring CBCT images, when the Float Image Selection button is pressed, it may display CBCT images that are insufficient in number.

During positioning within the system's 3D to 3D matching mode while transferring CBCT images, when the Float Image Selection button is pressed, it may display CBCT images that are insufficient in number.

Due to reported adverse events, Medline Industries, LP. is issuing a recall on specific SKUs and lots of 1500 cc semi-rigid liners manufactured from 09/2023-11/2023 due to the potential loss of suction or low suction during intermittent suction use.

Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

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Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

The recalled high chairs violate the regulations for high chairs, as the leg openings on the high chair are too wide, posing an entrapment hazard to infants. Additionally, the high chairs pose a fall hazard because the tray can become disengaged from the product.