Baby and kids' product recalls

Incorrect Urea results may be generated sporadically on cobas b 221<6>Roche OMNI S6 system and cannot be detected by QC. QC measurement results can be affected as well. This issue is only detectable if comparison result of a second measurement is available. The cause for this issue is an error in the software measurement procedure. In children, decreased urea results can point at inborn disorders or urea cycle. Therefore, false normal urea values could lead to delayed/incorrect diagnosis of such a disorder. Besides the patients most at risk, the risk for the overall patient population with falsely low or high values is considered remote. No severe adverse health effects are expected; but, unnecessary diagnostic measures may be initiated. Falsely normal results may result in further necessary examination not being carried out, with the possibility of a delay in the diagnosis and treatment. A medical risk cannot entirely be excluded.

Oxygen tubing and the oxygen connector of the Hamilton-MR1 could potentially become loose during the preparation for ventilation.

The weld between the slide bedway and sidewall can crack and separate. A child's fingers can get caught in the space, posing an amputation hazard.

The bath seats/chairs fail to meet the federal safety standard, including requirements for stability and the bath seats can tip over while a baby is in it, posing a drowning hazard to babies.

The firm announced a voluntary recall of various dietary supplement products due to misbranding and some products may contain undeclared HCG.

ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.

ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.

ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.

ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.

ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.

ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.

ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.

ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.

Stryker received several complaints describing incidence of harm secondary to taper lock failure for specific lots of numerous catalog numbers of LFIT Anatomic CoCr V40 Femoral Heads.

The rivets on the shoes have sharp edges, posing a laceration hazard.

The alarm can fail to continue to chirp when it reaches its 7-year end of life if the batteries are replaced, leading consumers to believe it is still working. This poses a risk of consumers not being alerted to a fire or CO incident in their home.

Labeling: Incorrect or Missing Package Insert - Xarelto prescribing information outserts may be affixed to the exterior of Invokamet bottles in place of the Invokamet prescribing information outsert.

A relay on the circuit board can fail causing the vehicle's motor to overheat and ignite, posing fire and burn hazards.

The firm received complaints that the wrong size scoop was in the product canister. Use of this scoop would only yield 60% nutrition instead of 100% nutrition.

Triceutical Inc. has recalled all dietary supplements due to lack of good manufacturing practices.

Triceutical Inc. has recalled all dietary supplements due to lack of good manufacturing practices.

Misbranding, Unreported Allergens

The carabiners attached to the strap system contain small internal parts that can become dislodged, posing a choking hazard to young children.

The gel clings can separate and expose the inner decal and LED/button battery compartment, posing choking and button battery ingestion hazards to children.

Siemens received multiple customer complaints indicating an increase in false positive and indeterminate patient sample results and increased imprecision for several lots of Rubella IgM assay on the IMMMULITE 2000/IMMULITE 2000 XPi platforms.

Siemens received multiple customer complaints indicating an increase in false positive and indeterminate patient sample results and increased imprecision for several lots of Rubella IgM assay on the IMMMULITE 2000/IMMULITE 2000 XPi platforms.

Two customer complaints suggest that excessive rotation of the cable in one direction (clockwise or counter-clockwise) without allowing the cable to unwind to its normal condition may cause the cable to break suddenly and the body shield to fall. While no injuries or deaths occurred in either failure, the Zero-GravityTM body shield weighs 55 pounds, and in the event of a cable failure, the body shield will fall immediately. A fall of this nature places the user, associated staff and the patient at risk for a potential injury.

Some packages of Taylor Farms Cranberry Walnut Salad kits may have the incorrect back label with ingredients for Taylor Farms Spinach Salad with Bacon and not properly declare walnuts or wheat. The Walnuts are clearly visible through the packaging.

The carriers' side strap can loosen unexpectedly from the buckle, posing a fall hazard to the child in the carrier.

The light cube's lithium polymer battery can overheat and catch fire, posing a fire hazard.