South Dakota recalls

The baby loungers violate the mandatory standard for Infant Sleep Products because the sides are shorter than the minimum side height limit to secure the infant; the sleeping pad's thickness exceeds the maximum limit, posing a suffocation hazard; and an infant could fall out of an enclosed opening at the foot of the lounger or become entrapped. The portable loungers do not have a stand, posing a fall hazard. These violations create an unsafe sleeping environment for infants, posing a risk of serious injury or death.

The recalled car seat adapters can fail to properly attach to the stroller, which may allow the car seat to fall, posing a risk of serious injury from a fall hazard.

The recalled children’s pajamas violate the mandatory flammability standard for children’s sleepwear, posing a risk of serious burn injuries or death.

The pajama sets violate the mandatory safety standards for children's sleepwear, posing a risk of serious injury or death to children from burns.

The pajama sets violate the mandatory safety standards for children's sleepwear, posing a risk of serious injury or death to children from burns.

The recalled drain covers violate the entrapment protection standards of the Virginia Graeme Baker Pool and Spa Safety Act (VGBA), posing entrapment and drowning hazards to consumers.

The recalled teething toys violate the mandatory standard for toys because the silicone strings are smaller and longer than permitted. The strings can reach the back of children's throat and become lodged, posing a serious risk of respiratory distress and deadly choking hazard.

The recalled toys violate the small parts ban because they are intended for children under three and the small pacifier poses a deadly choking hazard to young children. In addition, the eyes on the plush bear can detach, also posing a choking hazard.

Unreported Allergens

Boston Scientific is initiating a medical device removal of Orca Sterile, Single Use Air/Water and Suction Valves due to a higher than anticipated occurrence of the suction button sticking.

Inadvertent distribution of sealed pouches that had not undergone validated sterilization.

Inadvertent distribution of sealed pouches that had not undergone validated sterilization.

Inadvertent distribution of sealed pouches that had not undergone validated sterilization.

Inadvertent distribution of sealed pouches that had not undergone validated sterilization.

Software may fail to load adapted baseline shift plan during treatment delivery when a communication error occurs.

Software malfunction may occur during pacing capture threshold test of pacemaker resulting in programmer not successfully communicating the command to terminate the test.

Sterile anchors my lack sterility assurance.

Reusable electrodes may not meet expected performance levels.

Reusable electrodes may not meet expected performance levels.

Some units of Aluminum Chloride Gel contain the package insert for Ferric Sulfate Gel. The incorrect insert misidentifies the product and contains different first aid instructions, most critically in that the Ferric Sulfate insert instructs users to induce vomiting in the case of ingestion, while the correct Aluminum Chloride insert instructs users not to induce vomiting.

Through customer complaints, the ankle replacement system was found to contain incorrect devices: Left implant packaging and labeling bears a right implant device.

A potential positive bias in quality control (QC) and patient sample results in three lots of the Dimension Tacrolimus (TAC) Flex reagent cartridge.

It was reported that plates 2 and 3 were marked as passed , although it appeared that QC had not been performed on these plates, despite samples being measured. The potential clinical hazards include false or missed detection of M-protein (false positive); and falsely elevated or decreased M-protein concentration.

The cannulation of the CCS screw is not centered.

Yttrium-stabilized zirconium oxide discs for fixed all-ceramic dental restorations may have reduced or missing dentin layer and when used clinically in the patient's mouth there is an increased risk of fractures under functional stress.

Natus has become aware of two complaints related to the SD LTM 64 PLUS where the EEG traces acquired from two or four different amplifiers used in a multiple amplifier configuration (128 or 256 channels) running firmware version 2022.02 were displayed with a shift of 1 second between the 64channels blocks. In rare circumstances, a fixed 1-second temporal delay may appear between two 64-channel modules with firmware 2021.02, 2022.01 or 2022.02 in a multi-module SEEG configuration, potentially leading to misinterpretation of results.

Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.

Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.

Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.

Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.