All recalls7,869 total
A potential issue with the seal integrity of header bag packaging.
The possibility for this product that is intended for demonstration purposes only to be placed in patients.
Device kits contained an incorrectly sized 4mm x 4cm urinary tract balloon catheter (BURS0404) instead of the correct 8mm x 15cm nephrostomy tract balloon catheter (BPCN0815). All other components in the kits were correctly included and packaged in the kit.
Potential of negative recovery of the HBsAg analyte across two (2) lots of Multichem ID-B Positive Control when tested on the Alinity i platform.
A potential issue with the seal integrity of header bag packaging.
A potential issue with the seal integrity of header bag packaging.
A potential issue with the seal integrity of header bag packaging.
A potential issue with the seal integrity of header bag packaging.
Software application that receives digital images and data to be communicated, processed, manipulated, enhanced, stored, displayed has a bug that could cause data loss in Relevant Clinical Info field when modifying studies through Case Editor in either Technologist Portal or Referring Physician Portal, which could result in loss of clinical information, which could impact clinical decision-making.
Cooked egg ingredient for Ready-to-Eat products tested positive for Listeria Monocytogenes
Elevated levels of lead. FDA ground cinnamon sample was found to contain 2.92 mg/kg.
Cooked egg ingredient for Ready-to-Eat products tested positive for Listeria Monocytogenes
Failed Impurities/Degradation Specification: presence of N-nitroso Prazosin impurity C above the Carcinogenic Potency Categorization Approach (CPCA) acceptable intake limit
Failed Impurities/Degradation Specification: presence of N-nitroso Prazosin impurity C above the Carcinogenic Potency Categorization Approach (CPCA) acceptable intake limit
Failed Impurities/Degradation Specification: presence of N-nitroso Prazosin impurity C above the Carcinogenic Potency Categorization Approach (CPCA) acceptable intake limit
Affected system contains components that do not meet the required distance between electrodes for compliance with the IEC 60601-1 standard for medical electrical equipment.
Due to an issue (potential breakage) with the shaft for the mounting of the X-ray tube assembly that could potentially result assembly coming off the rotating shaft.
Products may contain elevated levels of lead.
Products may be contaminated with Listeria monocytogenes.
Products may be contaminated with Listeria monocytogenes.
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Half-pint chocolate fat free milk is recalled due to potential quality control issues.
CGMP Deviations: Potential presence of metal particulate matter
CGMP Deviations: Potential presence of metal particulate matter
CGMP Deviations: Potential presence of metal particulate matter
CGMP Deviations: Potential presence of metal particulate matter
CGMP Deviations: Potential presence of metal particulate matter
CGMP Deviations: Potential presence of metal particulate matter
CGMP Deviations: Potential presence of metal particulate matter
CGMP Deviations: Potential presence of metal particulate matter
CGMP Deviations: Potential presence of metal particulate matter
CGMP Deviations: Potential presence of metal particulate matter
CGMP Deviations: Potential presence of metal particulate matter
CGMP Deviations: Potential presence of metal particulate matter
CGMP Deviations: Potential presence of metal particulate matter
CGMP Deviations: Potential presence of metal particulate matter
CGMP Deviations: Potential presence of metal particulate matter
BD has confirmed through internal testing that certain device trays failed routine biocompatibility testing.
Continued reports of positive cultures and infections have identified updates to the reprocessing materials to minimize potential deviations in TJF duodenoscope reprocessing. Olympus is informing users of these changes, reminding users to closely follow the operation and reprocessing instructions, and providing updated materials to users.
Bicarbonate reagent may generate falsely high Bicarbonate results due to interference with Lactate Dehydrogenase (LDH) in the test sample.
Undeclared Yellow 5, Yellow 6
Subpotent drug; Clavulanate Potassium component