All Recalls

Potential to be contaminated with Clostridium botulinum. Product was tested and found to have pH level of 4.9.

Potential to be contaminated with Clostridium botulinum. Product was tested and found to have pH level of 4.9.

Brie cheese has the potential to be contaminated with Listeria monocytogenes.

Subpotent Drug: Out of specification for assay

Chemical Contamination and CGMP Deviations: trace amounts of methanol found in one of the components during the manufacturing process.

cGMP Deviations: Out of specification for assay of one of the preservative ingredients.

Label Mix - up; a bottle labeled as Atenolol 25mg Tablets contained Clopidogrel 75mg Tablets

Defective Container: Complaints received of vial breakage and glass flying when pressurized while preparing the product for administration

Defective Container: Complaints received of vial breakage and glass flying when pressurized while preparing the product for administration

CGMP Deviations: Detection of N-Nitroso-quinapril impurity above the acceptable daily intake limit.

Chemical Contamination and CGMP Deviations: trace amounts of methanol found in one of the components during the manufacturing process.

Inadvertent energy delivery from surgical system instrument if 1) Force bipolar and bipolar instruments installed on system 2) Force bipolar connected to Force Triad generator, bipolar not connected to generator 3) Yellow pedal associated with force bipolar is pressed, released with head in surgeon console 4) Blue pedal associated with bipolar is pressed, resulting in force bipolar energy delivery

The balloon volume is incorrectly described as 34cc instead of 40cc on one of the three internal labels enclosed for hospital use. A labelling error may result in user confusion and/or delay in initiating therapy. Therapy delays may impact those patients who are more hemodynamically unstable.

Adult Blood Culture Collect kit and Pre-Op Changing Bathing Kit contain an incorrect expiration date on a component with the kit. CHG Solution with the Pre-Op Changing Bathing Kit and Bactec bottle plastic both have an expiration date that does not match the date listed on the kit.

impaired functionality of the release liner

impaired functionality of the release liner

Hip liner implant boxes may contain knee inserts and knee insert boxes may contain hip liner implants, which may lead to implants not being available for surgeries, which may cause delays in surgery.

Biopsy Systems have components that are misaligned due to an issue with the manufacturing assembly equipment, which may lead to the needle ejecting when triggered outside the body, which may result in user or patient needle stick injury.

The tibial tray lock detail is oversized (larger than specification).

A part defect with the wash 1 syringe of an SARS-CoV-2 assay could lead to incomplete extraction thereby producing an invalid or false negative assay result.