95,018 total recalls in our database
Central Admixture Pharmacy Services
Lack of Assurance of Sterility:Lack of validation data for sanitization cycles
Central Admixture Pharmacy Services
Lack of Assurance of Sterility:Lack of validation data for sanitization cycles
Central Admixture Pharmacy Services
Lack of Assurance of Sterility:Lack of validation data for sanitization cycles
Central Admixture Pharmacy Services
Lack of Assurance of Sterility:Lack of validation data for sanitization cycles
Central Admixture Pharmacy Services
Lack of Assurance of Sterility:Lack of validation data for sanitization cycles
Central Admixture Pharmacy Services
Lack of Assurance of Sterility:Lack of validation data for sanitization cycles
Central Admixture Pharmacy Services
Lack of Assurance of Sterility:Lack of validation data for sanitization cycles
Marketed Without an Approved NDA/ANDA: FDA analysis found the product to be tainted with sildenafil an ingredient found in a FDA approved product for the treatment of male sexual enhancement, making this an unapproved drug.
Olympus Corporation of the Americas
Complaint of endoscope model becoming lodged in the endotracheal tube connector due to diameter being too large.
Siemens Healthcare Diagnostics
There is potential for discrepant high glucose results in samples with glucose results on the lower end of the reportable range.
Users were reporting that the device was not charging as expected. It was discovered that users were unaware that the Cardiosave console was not completely inserted into the hospital cart. If the console is not fully inserted back into the cart the battery(ies) will not charge.
Epoxy used during manufacturing of the LifeSPARC Pump may have uncured epoxy. if undetectable curing may result in added risk of early pump failure,
Users were reporting instances of "Gas Loss in IAB Circuit" and "Gas Gain in IAB Circuit" alarms while providing therapy. An internal investigation of the complaints determined that there is a potential trigger for these alarms that was not listed in the IFU: Patient Movement (coughing, general movement, and swallowing). Blood in the circuit, kins and abrasions of the tubing/catheter and certain patient conditions could also trigger these alarms. The HHE also identified hardware issues related to these alarms.
Oculus Optikgeraete GMBH
Their is a potential that optical devices with insufficient anti-reflective coating may lead to incorrect axial length measurements.
Siemens Healthcare Diagnostics
Reagent Carryover from LDL Cholesterol Direct (DLDL), Total Protein II (TP), Triglycerides (Trig), and Triglycerides_2 (Trig_2) Impacting Magnesium (Mg) Results
Olympus Corporation of the Americas
Complaint of endoscope model becoming lodged in the endotracheal tube connector due to diameter being too large.
Olympus Corporation of the Americas
Complaint of endoscope model becoming lodged in the endotracheal tube connector due to diameter being too large.
Siemens Healthcare Diagnostics
Potential for reagent carryover on the Atellica CH 930 resulting in a positive bias that could impact quality control (QC), patient samples, and calibrator results with from Atellica¿CH Total Bilirubin_2 (TBil_2), Atellica¿ CH LDL Cholesterol (LDLC), Atellica¿ CH Gamma-Glutamyl Transferase (GGT) and Atellica¿ CH HDL Cholesterol (HDLC)
Siemens Healthcare Diagnostics
Potential for reagent carryover on the Atellica CH 930 resulting in a positive bias that could impact quality control (QC), patient samples, and calibrator results with from Atellica¿ CH Total Bilirubin_2 (TBil_2), Atellica¿ CH LDL Cholesterol (LDLC), Atellica¿ CH Gamma-Glutamyl Transferase (GGT) and Atellica CH HDL Cholesterol (HDLC)
Siemens Healthcare Diagnostics
Reagent Carryover from LDL Cholesterol Direct (DLDL), Total Protein II (TP), Triglycerides (Trig), and Triglycerides_2 (Trig_2) Impacting Magnesium (Mg) Results