Baby and kids' product recalls

Misbranding, Unreported Allergens

During the firm's review of May 2019 complaint data, a significant increase in Disposable Core Biopsy Instrument complaints were observed for Failure to Fire, Firing Problem, and Failure to Obtain Samples.

There is a potential patient health risk while performing chronic hemodialysis treatments in the home setting with for patients with low blood volume (2.4 Liters or less in a patient with body weight of 30kg or less) when prescribing larger dialysate volumes.

Firm is recalling one lot of baby broccoli because it may be contaminated with bacteria contained in dripping ice water from a drain tray in the cooler.

The battery cover can detach and expose the button-cell batteries, posing choking and ingestion hazards to young children.

A welded rung opening on the sides of the climber poses an entrapment hazard to children.

During testing on the Habib EUS RFA device, a temperature increase was observed at the tip of the EUS-FNA needle. It was determined that capacitive 5 coupling presents a risk of energy transfer from the Habib EUS RFA active tip to the introducer device. This capacitive coupling could result in thermal injury to tissue outside of the targeted treatment area due to its use with an un-insulated EUS-FNA needle requiring little or no medical intervention.

During testing on the Habib EUS RFA device, a temperature increase was observed at the tip of the EUS-FNA needle. It was determined that capacitive 5 coupling presents a risk of energy transfer from the Habib EUS RFA active tip to the introducer device. This capacitive coupling could result in thermal injury to tissue outside of the targeted treatment area due to its use with an un-insulated EUS-FNA needle requiring little or no medical intervention.

The firm received a customer complaint describing a metal filament in a bottle of one lot of Sofrito Cilantro 32 oz. Further investigation determined that the same type of metal filament was found in raw material (dehydrated minced onion) used in the manufacture of Sofrito Cilantro 32 oz and other products.

The firm received a customer complaint describing a metal filament in a bottle of one lot of Sofrito Cilantro 32 oz. Further investigation determined that the same type of metal filament was found in raw material (dehydrated minced onion) used in the manufacture of Sofrito Cilantro 32 oz and other products.

The firm received a customer complaint describing a metal filament in a bottle of one lot of Sofrito Cilantro 32 oz. Further investigation determined that the same type of metal filament was found in raw material (dehydrated minced onion) used in the manufacture of Sofrito Cilantro 32 oz and other products.

The firm received a customer complaint describing a metal filament in a bottle of one lot of Sofrito Cilantro 32 oz. Further investigation determined that the same type of metal filament was found in raw material (dehydrated minced onion) used in the manufacture of Sofrito Cilantro 32 oz and other products.

Defective delivery system; product is not foaming or is coming out as liquid.

The chests are unstable and can tip over if not anchored to the wall, posing serious tip-over and entrapment hazards that can result in death or injuries to children. The chests do not comply with the performance requirements of the U.S. voluntary industry standard (ASTM F2057-17).

Small stones can be present in the pockets or waistband of the pants from the stone washing manufacturing process, posing aspiration or choking hazards to young children.

Giraffe Incubator, Giraffe OmniBed, Giraffe Incubator Carestation, and Giraffe OmniBed Carestation Bedside panels and portholes can appear closed without being latched. Potential patient fall.

Giraffe Incubator, Giraffe OmniBed, Giraffe Incubator Carestation, and Giraffe OmniBed Carestation Bedside panels and portholes can appear closed without being latched. Potential patient fall.

Giraffe Incubator, Giraffe OmniBed, Giraffe Incubator Carestation, and Giraffe OmniBed Carestation Bedside panels and portholes can appear closed without being latched. Potential patient fall.

Giraffe Incubator, Giraffe OmniBed, Giraffe Incubator Carestation, and Giraffe OmniBed Carestation Bedside panels and portholes can appear closed without being latched. Potential patient fall.

The bassinet's support legs can break, posing a fall hazard to babies.

Separation of the pawl assembly and hub may cause the swing arms on the Easy Cover tarping system to unexpectedly swing to the back of the dump body, increasing the risk of injury.

Product contains high levels of sulfites (114.65 mg/serving)

Lack of Assurance of Sterility

Lack of Assurance of Sterility

Hazards include infant fatalities, fire, burn, choking, fall, laceration, skin irritation, explosion or other injuries depending on the product.

Product Contamination

The product contains the substance methyl salicylate, 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.

Product Contamination

FDA determined that marketing claims surrounding product rendered product a medical device which was adulterated and misbranded.

The product contains the substance methyl salicylate, 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.