All Recalls

Difficult to expel Geistlich Bio-Oss granules from the pen, resistance could suddenly drop, and the granules may be expelled all at once, causing surrounding tissue, particularly in use for the sinus lift indication and while unlikely, could pose a risk for patient harm, including irritation of the oral mucosa or even a perforation of the Schneiderian membrane

Difficult to expel Geistlich Bio-Oss granules from the pen, resistance could suddenly drop, and the granules may be expelled all at once, causing surrounding tissue, particularly in use for the sinus lift indication and while unlikely, could pose a risk for patient harm, including irritation of the oral mucosa or even a perforation of the Schneiderian membrane

There have been issues experienced with the peg preparation steps, specifically drilling of the Femoral posterior peg. Upon drilling, the shaft portion of the drill may bind within the Posterior Peg drill guide. The extended length of the drill guide and tight tolerances to ensure accurate preparation seem to be contributing to this situation. There is a potential of a delay in surgery if this issue were to recur.

When the video stylet cuff is over-inflated there is potential for occlusion of the corrugated section of the ETT, and increased resistance to gas flow and difficulty in ventilating the patient.

There have been issues experienced with the peg preparation steps, specifically drilling of the Femoral posterior peg. Upon drilling, the shaft portion of the drill may bind within the Posterior Peg drill guide. The extended length of the drill guide and tight tolerances to ensure accurate preparation seem to be contributing to this situation. There is a potential of a delay in surgery if this issue were to recur.

The candles' high flames can ignite the surface of the wax or cause the glass to break, posing fire and burn hazards.

Potential salmonella contamination in elderberries.

Product may be contaminated with Listeria monocytogenes.

Possible contamination with Listeria monocytogenes.

Processing error resulting in mixing of pasteurized and raw cider into final product.

Firm was notified by supplier of Elder Berries of a recall due to potential Salmonella contamination.

Undeclared Wheat and Milk.

Stabilizer was made with Citric Acid instead of Sodium Citrate.

Stabilizer was made with Citric Acid instead of Sodium Citrate.

Potential Foreign Material

CGMP Deviations: Next Advanced Antibacterial Hand Sanitizer was found to be below the label claim for ethanol content and contained methanol. Other products were recalled because they were manufactured in the same facility as the product found to contain methanol.

Labeling: Product Contains Undeclared API; Incorrect formulation

GMP Deviations

Failed Dissolution Specifications: Out of specification for dissolution.