💊 Drugs Class I - Dangerous
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
All Recalls
95,114 total recalls in our database
Benzonatate Capsules, USP, 100 mg, 100 Capsules (10 capsules x 10 unit dose cards), Rx only, Distributed by: American Health Packaging, Columbus, Ohio 43217. Carton NDC 68084-214-01; Individual Dose NDC 68084-214-11
Amerisource Health Services
💊 Drugs Class I - Dangerous
Superpotent drug: Assay results were slightly above specification at the time zero point.
💊 Drugs Class I - Dangerous
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Vasopressin 2 Unit/2 mL in 0.9% Sodium Chloride, 2 mL per syringe, Rx Only, 719 Kasota Ave SE, Minneapolis, MN. NDC 71139-0190-1
IntegraDose Compounding Services
💊 Drugs Class I - Dangerous
Subpotent Drug
💊 Drugs Class I - Dangerous
Lack of Sterility Assurance: Aseptic process simulation failure.
💊 Drugs Class I - Dangerous
Failed Excipient Specifications: OOS for assay of Isopropyl Alcohol
🏥 Medical Devices Class I - Dangerous
BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes with ENFit Connectors, inadequate or reduced suction, decompression, and drainage occurred.
🏥 Medical Devices Class I - Dangerous
BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes with ENFit Connectors, inadequate or reduced suction, decompression, and drainage occurred.
VITROS Immunodiagnostic Products Anti-HBs Quantitative Reagent Pack, Catalog No. 6801925 VITROS Immunodiagnostic Products Anti-HBs Calibrators, Catalog No. 6801926
Ortho-Clinical Diagnostics
🏥 Medical Devices Class I - Dangerous
Affected lots may experience increased calibration failures or an increase in falsely elevated results.
🏥 Medical Devices Class I - Dangerous
BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes with ENFit Connectors, inadequate or reduced suction, decompression, and drainage occurred.
🏥 Medical Devices Class I - Dangerous
BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes with ENFit Connectors, inadequate or reduced suction, decompression, and drainage occurred.
🏥 Medical Devices Class I - Dangerous
BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes with ENFit Connectors, inadequate or reduced suction, decompression, and drainage occurred.
🏥 Medical Devices Class I - Dangerous
BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes with ENFit Connectors, inadequate or reduced suction, decompression, and drainage occurred.
🏥 Medical Devices Class I - Dangerous
Beckman Coulter has become aware that the cannula, which is found in the Flowcell and the iQClear Rinse Waste Well Assembly, may rust. Rust from the cannula has the potential to generate erroneous results.
🏥 Medical Devices Class I - Dangerous
Beckman Coulter has become aware that the cannula, which is found in the Flowcell and the iQClear Rinse Waste Well Assembly, may rust. Rust from the cannula has the potential to generate erroneous results.
🏥 Medical Devices Class I - Dangerous
Knee batteries may need replacement with conforming batteries to ensure there isn't a failure to turn on the device, or an unexpected shutdown, which is a momentary loss of power to the knee where the user may experience loss of support that can lead to a fall and potential injury.
TactiFlex Ablation Sensor Enabled Ablation Catheter, Models A-TFSE-FJ, 7.5 F shaft and an 8F distal section, Sterile.
St. Jude Medical, Atrial Fibrillation Division
🏥 Medical Devices Class I - Dangerous
When the catheters are used with the EnSiteX EP System, the system does not correctly recognize the catheter as the appropriate product model and instead reads and displays it as a different model. This results in some features specific to the catheter do not appear on the display and the catheter image may also appear inverted.
🏥 Medical Devices Class I - Dangerous
BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes with ENFit Connectors, inadequate or reduced suction, decompression, and drainage occurred.
🏥 Medical Devices Class I - Dangerous
BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes with ENFit Connectors, inadequate or reduced suction, decompression, and drainage occurred.
iQ Waste Well Adapter, Part Number: 700-3393
Beckman Coulter
🏥 Medical Devices Class I - Dangerous
Beckman Coulter has become aware that the cannula, which is found in the Flowcell and the iQClear Rinse Waste Well Assembly, may rust. Rust from the cannula has the potential to generate erroneous results.