💊 Drugs Class I - Dangerous
Marketed without an approved NDA/ANDA: FDA analysis determined presence of the pharmaceutical ingredients Sibutramine and Fluoxetine
All Recalls
95,114 total recalls in our database
Atorvastatin Calcium Tablets, USP 10 mg, 500-count bottles, Rx Only, Dr. Reddy's Mfd. By: Dr. Reddy's Laboratories Limited, Bachupally, 500-090 India, NDC 55111-121-05.
Dr. Reddy's Laboratories
💊 Drugs Class I - Dangerous
Failed Impurities/Degradation Specifications: due to presence of ATV cyclo IP and FP impurities
💊 Drugs Class I - Dangerous
Subpotent
🏥 Medical Devices Class I - Dangerous
The company was notified by their supplier of sterilization services for airway products in Italy of potential deviations from validated parameters for ethylene oxide sterilization.
Atellica CH 930 Analyzer with Photometer Lamp (SMN 11075676) Siemens Material Number: 11067000
Siemens Healthcare Diagnostics
🏥 Medical Devices Class I - Dangerous
Photometer Lamp May Reach Saturation Without Flagging Results, may generate erroneously elevated or depressed patient results
🏥 Medical Devices Class I - Dangerous
The company was notified by their supplier of sterilization services for airway products in Italy of potential deviations from validated parameters for ethylene oxide sterilization.
Corin TriIFit TS SIZE 2, STANDARD TAPERED STEM, CEMENTLESS, REF 694.0002. Hip prosthesis component.
Corin
🏥 Medical Devices Class I - Dangerous
Units from one batch of TriFit TS size 2 stem were found to be labeled as a TriFit CF size 7 stem. And vice versa.
Medtronic HY10L28R3, Custom Pack HY10L28R3 1/4 Pack, Custom Perfusion System, Sterile, Rx.
Medtronic Perfusion Systems
🏥 Medical Devices Class I - Dangerous
Specific lots may have been manufactured with insufficient or incomplete welds.
Medtronic CB10Y89R10, Custom Pack CB10Y89R10 ECC 3/8 A/V, Custom Perfusion System, Sterile, Rx.
Medtronic Perfusion Systems
🏥 Medical Devices Class I - Dangerous
Specific lots may have been manufactured with insufficient or incomplete welds.
E3800 PC Units (spare parts)
Radiometer Medical ApS
🏥 Medical Devices Class I - Dangerous
Due to an issue with the internal clock of the analyzers with an e3800 PC unit installed.
🏥 Medical Devices Class I - Dangerous
The lot may have experienced an anomaly during the manufacturing process, that could lead to an out of specification concentrate formulation.
Medtronic CB10W64R1, Custom Pack CB10W64R1 CH Access 3/8, Custom Perfusion System, Sterile, Rx.
Medtronic Perfusion Systems
🏥 Medical Devices Class I - Dangerous
Specific lots may have been manufactured with insufficient or incomplete welds.
Medtronic CB10W63R1, Custom Pack CB10W63R1 HL 20 1/4, Custom Perfusion System, Sterile, Rx.
Medtronic Perfusion Systems
🏥 Medical Devices Class I - Dangerous
Specific lots may have been manufactured with insufficient or incomplete welds.
Medtronic BB8M63R5, Custom Pack BB8M63R5 Adult ECC, Custom Perfusion system, Sterile, Rx.
Medtronic Perfusion Systems
🏥 Medical Devices Class I - Dangerous
Specific lots may have been manufactured with insufficient or incomplete welds.
Medtronic BB10R94R6, Custom Pack BB10R94R6 1/4 ECCPK, Custom Perfusion System, Sterile, Rx.
Medtronic Perfusion Systems
🏥 Medical Devices Class I - Dangerous
Specific lots may have been manufactured with insufficient or incomplete welds.
Medtronic CB7J98R7, Custom Pack CB7J98R7, Custom Pack CB7J98R7 3/8 Pack, Custom Perfusion System, Sterile, Rx.
Medtronic Perfusion Systems
🏥 Medical Devices Class I - Dangerous
Specific lots may have been manufactured with insufficient or incomplete welds.
Medtronic CB4W67R20, Custom Pack CB4W67R20 Adult E, Custom Perfusion System, Sterile, Rx.
Medtronic Perfusion Systems
🏥 Medical Devices Class I - Dangerous
Specific lots may have been manufactured with insufficient or incomplete welds.
Medtronic CB10R79R6, Custom Pack CB10R79R6 1/4X1/4 Loop, Custom Perfusion System, Sterile, Rx.
Medtronic Perfusion Systems
🏥 Medical Devices Class I - Dangerous
Specific lots may have been manufactured with insufficient or incomplete welds.
🏥 Medical Devices Class I - Dangerous
The IGS system can experience a single vertical line defect where the vertical line divides and horizontally shifts live monitor images into two unequal image parts within the monitor display screen.
Reports of the proximal end of the stent not immediately expanding upon deployment and remaining connected to the delivery system.