🏥 Medical Devices Class I - Dangerous
Product did not meet the acceptance criteria for packaging testing, which included 3-year age acceleration testing, therefore, the sterility of the device may be compromised.
All Recalls
95,018 total recalls in our database
🏥 Medical Devices Class I - Dangerous
Due to a manufacturing defect which results in a visible gap between the connector's top and bottom housing.
🏥 Medical Devices Class I - Dangerous
Specific GXL acetabular polyethylene liners, packaged in non-conforming bags, may adversely impact the device and contribute to accelerated wear.
🏥 Medical Devices Class I - Dangerous
Due to a manufacturing defect which results in a visible gap between the connector's top and bottom housing.
🏥 Medical Devices Class I - Dangerous
Product did not meet the acceptance criteria for packaging testing, which included 3-year age acceleration testing, therefore, the sterility of the device may be compromised.
🏥 Medical Devices Class I - Dangerous
Product did not meet the acceptance criteria for packaging testing, which included 3-year age acceleration testing, therefore, the sterility of the device may be compromised.
🏥 Medical Devices Class I - Dangerous
Acidified Concentrate Distribution System potential electrical safety hazard may result in electric shock, arching
🏥 Medical Devices Class I - Dangerous
Product did not meet the acceptance criteria for packaging testing, which included 3-year age acceleration testing, therefore, the sterility of the device may be compromised.
Specific GXL acetabular polyethylene liners, packaged in non-conforming bags, may adversely impact the device and contribute to accelerated wear.
Verify SixCess Challenge Pack. Used to confirm that critical parameters of steam sterilization have been reached within a challenging test pack design.
Steris Corporation Hopkins Facility
🏥 Medical Devices Class I - Dangerous
Product contains incorrect chemical indicators in packaging.
🏥 Medical Devices Class I - Dangerous
Due to a manufacturing defect which results in a visible gap between the connector's top and bottom housing.
Disposable Subdermal Needle Electrode, Pt/lr, 12 x 0.40mm, product number TE/S46/638, 25 needles per package, sterile.
Technomed Europe
🏥 Medical Devices Class I - Dangerous
Burns of varying degrees can occur to patients with electrodes left in while in the MRI scanner as a result of inadequate safety information in the IFU.
Surpria 64: Software Version V3.11, V3.22
FUJIFILM Healthcare Americas
🏥 Medical Devices Class I - Dangerous
Error 00003050 or 00003052 may occur during scanning, the captured images will not be reconstructed and the Raw Data will not be displayed in the work list.result, may result in the need for additional scanning to capture the images properly for reconstruction, thereby exposing the patient to additional radiation
🏥 Medical Devices Class I - Dangerous
Specific GXL acetabular polyethylene liners, packaged in non-conforming bags, may adversely impact the device and contribute to accelerated wear.
🏥 Medical Devices Class I - Dangerous
Sterility with new cotton source not validated
🏥 Medical Devices Class I - Dangerous
Primary Pump Tubing Spare Part is incorrect. If the tubing is installed onto an ALCOR iSED ESR Analyzer, there is a potential of a biohazard leak from the iSEDs Probe Tube
BIOPHEN UFH Control Plasma
Aniara Diagnostica
🏥 Medical Devices Class I - Dangerous
Incorrect product labeling was included in the package.
Specific GXL acetabular polyethylene liners, packaged in non-conforming bags, may adversely impact the device and contribute to accelerated wear.
🏥 Medical Devices Class I - Dangerous
Product did not meet the acceptance criteria for packaging testing, which included 3-year age acceleration testing, therefore, the sterility of the device may be compromised.
PTS Panels CHOL+GLU Test Strips (REF 1765)
Polymer Technology Systems, Inc.
🏥 Medical Devices Class I - Dangerous
Incorrect instructions for use were packaged into the final product.