Baby and kids' product recalls

The touchscreen on the treadmill can detach and fall, posing a risk of injury to consumers.

Adult users, children, pets and objects can be pulled underneath the rear of the treadmill, posing a risk of injury or death.

Infant fatalities have been reported with other manufacturers' inclined sleep products, after the infants rolled from their back to their stomach or side, or under other circumstances.

The size of the neck opening is too large for infants 0 to 6 months, which can allow an infant's head to slip into and be covered by the sleep bag, posing a risk of suffocation.

The products contain sodium hydroxide, which must be in child resistant packaging as required by the Poison Prevention Packaging Act (PPPA). The packaging of the products is not child resistant, posing a risk of chemical burns and irritation to the skin and eyes. In addition, the label on the products violate the Federal Hazardous Substance Act (FHSA) by omitting the word "poison" and other mandatory information on the packaging.

IFU and Patient Manual updated to describe Expected Alarm Duration. The Instructions for Use (IFU) is being updated to advise clinicians that alarms that resolve after a very short period may mean there is an intermittent problem and the cause of the alarm can be evaluated by analysis of the controller log files. The Patient Manual (PM) is being updated to instruct patients to contact their clinicians if they cannot identify an alarm before it is cleared as it might mean there is an intermittent problem. NOTE: this update is included in the February 2021 Urgent Medical Device Notice also covered in recalls 87456 and 87604

IFU and Patient Manual updated to describe HVAD Controller Connection Verification. The labeling is being corrected to reflect the actual verified behavior of a successful connector to the controller, which is a "beep" and not "audible click", to clarify under what alarm conditions a beep will not be heard, and identify alternate confirmation methods (visual indicator) for successful connection. NOTE: this update is included in the February 2021 Urgent Medical Device Notice also covered in recalls 87456 and 87603

Foreign object found in bottle.

The product is a dietary supplement containing iron, which must be in child resistant packaging, as required by the Poison Prevention Packaging Act (PPPA). The packaging of the product is not child resistant, posing a poisoning risk if the contents are swallowed by young children.

The packaging is not child resistant as required by the Poison Prevention Packaging Act. The pain relieving cream contains lidocaine, posing a risk of poisoning to young children if they put it on their skin or ingest it.

Inadequate images resizing and 2D measurement errors may occur when biplanar acquisition has been performed with patient orientation different from AP (Antero-Posterior).

The recalled jackets have a drawstring in the hood and a drawsting in the waist area that can become entangled or caught on playground slides, hand rails, school bus doors or other moving objects, posing a strangulation and/or an entrapment hazard to children.

Product Contamination

Product Contamination

Products show heavy growth of C. albicans after 24 hours of incubation due to misformulation (expected reaction is partial inhibition after 18-48 hours incubation) and reduce the identification of Neisseria contributing to a delay in time to definitive diagnosis or a delay in proper treatment

Products show heavy growth of C. albicans after 24 hours of incubation due to misformulation (expected reaction is partial inhibition after 18-48 hours incubation) and reduce the identification of Neisseria contributing to a delay in time to definitive diagnosis or a delay in proper treatment

The firm received positive test results for Listeria monocytogenes during in house environmental sampling on one of their meat slicers.

Labeling: Label-mixup

The abacus ring on the horses back can dislodge and release the small beads, posing a choking hazard to small children.

The heart-shaped graphics located on the knees of the romper can peel off or detach, posing a choking hazard to children.

The plastic wings can detach from the body of the teether, posing a choking hazard to young children.

Product Contamination

These products contain the substance methyl salicylate, which must be in child resistant packaging, as required by the Poison Prevention Packaging Act (PPPA). The packaging of the products is not child resistant, posing a risk of poisoning if the contents are swallowed by young children.

The capsule may fail to attach to the esophageal mucosa, which in turn may lead to the aspiration of the capsule. In the event of capsule aspiration, immediate intervention to remove the capsule is required. Potential outcomes following capsule aspiration include low oxygen saturation, intervention to retrieve the capsule, potential need to intubate the patient, extended hospital stay and a delay of treatment. Thirteen reports of capsule aspiration have been received the last 2 years.

The capsule may fail to attach to the esophageal mucosa, which in turn may lead to the aspiration of the capsule. In the event of capsule aspiration, immediate intervention to remove the capsule is required. Potential outcomes following capsule aspiration include low oxygen saturation, intervention to retrieve the capsule, potential need to intubate the patient, extended hospital stay and a delay of treatment. Thirteen reports of capsule aspiration have been received the last 2 years.

The Buttermik powder may contain a Foreign Material (metal).

The recalled bath wraps fail to meet flammability standards for children's sleepwear, posing a risk of burn injuries to children.

The bath seats fail to meet the federal safety standard for infant bath seats, including requirements for stability, and can tip over while in use, posing a drowning hazard to babies.

The products contain the substance methyl salicylate, which must be in child resistant packaging as required by the Poison Prevention Packaging Act (PPPA). The packaging of the products is not child resistant, posing a risk of poisoning if the contents are applied to the skin or swallowed by young children.

Products being recalled due to potentially elevated level of bacterial endotoxin. Patients exposed to elevated levels of bacterial endotoxins may develop an acute inflammatory response.