95,094 total recalls in our database
Central Admixture Pharmacy Services
Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
Sub-potent Drug
Central Admixture Pharmacy Services
Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
Central Admixture Pharmacy Services
Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
Teva Pharmaceuticals USA
Labeling: Incorrect or Missing Package Insert
Central Admixture Pharmacy Services
Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
Central Admixture Pharmacy Services
Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
Central Admixture Pharmacy Services
Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
Central Admixture Pharmacy Services
Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
Central Admixture Pharmacy Services
Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
Sagent Pharmaceuticals
Lack of Assurance of Sterility
SUN PHARMACEUTICAL INDUSTRIES
Failed Dissolution Specifications; during stability testing
Siemens Medical Solutions USA
Under certain unlikely circumstances during a fluoroscopic examination, the imaging system Fluorospot Compact might sporadically display an incorrect air kerma/air kerma rate related to the patient reference point, according to IEC 60601-2-43. There is no impact on workflow or diagnosis. The error can occur only in fluoroscopy systems with a second (overhead) X-ray tube. Siemens Healthineers became aware of one customer site where this issue was identified during clinical operation.
There is a potential for a disruption in one or more of the triple layer membranes of the ventricular assist device. Recall occurred in 2018, and was retrospectively reported.
The liquid buffer component in the affected test kit lots was determined to have bacterial contamination. User may notice a slight odor when the buffer is brought close to the nose.
PHILIPS HEADQUARTERS CAMBRIDGE
Potential for Incorrect Image Orientation resulting images may be flipped or reversed result in misdiagnosis, incorrect treatment of a condition, or additional radiation exposure if a rescan is required
Olympus Corporation of the Americas
Product non-conformance pertaining to the angle of the needle does not meet manufacturing specifications and remained unbent, resulting to slight resistance experienced during needle advancement and retraction.
Ortho-Clinical Diagnostics
Potential for both unexpected positive and negative HbA1c results, may result in misdiagnosis
Olympus Corporation of the Americas
Product non-conformance pertaining to the angle of the needle does not meet manufacturing specifications and remained unbent, resulting to slight resistance experienced during needle advancement and retraction.
Windstone Medical Packaging
Light handle covers may separate from the light handle (detach and fall off) during use, this could result in a procedure delay and/or impact the sterile field which could result in an injury to the patient