95,083 total recalls in our database
Qinhuangdao Zizhu Pharmaceutical
cGMP Deviations; lack of quality assurance.
Qinhuangdao Zizhu Pharmaceutical
cGMP Deviations; lack of quality assurance.
Qinhuangdao Zizhu Pharmaceutical
cGMP Deviations; lack of quality assurance.
Failed Tablet/Capsule Specifications; during an internal inspection, capsules were found with illegible print.
cGMP Deviations; manufacturer initiated recall of API product after deficiencies noted during a recent FDA inspection
Failed Impurities/Degradation Specifications: high out of specification results for one of the known degradation products, m-chlorobenzoic acid.
cGMP Deviations; manufacturer initiated recall of API product after deficiencies noted during a recent FDA inspection
Chemical Contamination
Allergan Sales
Failed Impurities/Degradation Specifications
Use of the software may show an incorrect value to the user when viewing the Fractional Flow Reserve (FFR) results during recording.
Smiths Medical ASD
Smiths Medical has become aware that the drawing on the Instructions for Use (IFU) on certain yellow striped CADD¿ Administration Sets (part number 21-7339-24), incorrectly represent the actual filter size of the product. Although the text description on the IFU correctly identifies the product to include a 0.2 micron filter, the illustration on the IFU identifies the filter size as 2.0 microns.
Windstone Medical Packaging
AMS custom kits containing Medtronic Covidien Curity Eye Pad are recalled due to the potential for the sterile packaging of the eye pad to be compromised.
For over a year, the Accessory Packages in the Hyfrecator 2000 ESU cartons were packaged in error by the manufacturer with non-sterile P/N 7-796-19 Handpiece Sheaths in pouches that were labeled as Sterile. This could cause an end user to use a non-sterile sheath as if it were Sterile.
During an FDA inspection it was found that the firm claims unapproved therapy and medical claims on product information and website.
Windstone Medical Packaging
AMS custom kits containing Medtronic Covidien Curity Eye Pad are recalled due to the potential for the sterile packaging of the eye pad to be compromised.
Intuitive Surgical has become aware that in specific scenarios with system software P6 and the da Vinci Xi Suction Irrigator (PN 480299-03), users can experience unexpected motion of a system arm.
A complaint was received on January 1, 2017 stating the pigtail on line 2 of the oxygenator was assembled to the port where the yellow cap and the clear cap remained on the center port.
ORTHO-CLINICAL DIAGNOSTICS
Increased frequency of calibration failures for VITROS Immunodiagnostic Products NT-proBNP Reagent Lots 1568, 1570, 1580 and 1590, due to background signals for these affected NT-proBNP lots that have been increasing with time since release testing, resulting in higher than expected VITROS Immunodiagnostic Products NT-proBNP level 1 calibrator signals produced, leading to calibration failures.
2k Innovations
During an FDA inspection it was found that the firm claims unapproved therapy and medical claims on product information and website.
Merge Healthcare
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