💊 Drugs Class I - Dangerous
Failed Impurities/Degradation Specifications: High Out Of Specification results for impurities detected during routine stability testing.
All Recalls
95,038 total recalls in our database
💊 Drugs Class I - Dangerous
Failed Impurities/Degradation Specifications
💊 Drugs Class I - Dangerous
Failed Impurities/Degradation Specifications
💊 Drugs Class I - Dangerous
Microbial Contamination of Non-Sterile Products: products were found to be contaminated and above specification for lidocaine assay.
💊 Drugs Class I - Dangerous
Failed Impurities/Degradation Specifications
💊 Drugs Class I - Dangerous
Failed Impurities/Degradation Specifications
💊 Drugs Class I - Dangerous
Failed Impurities/Degradation Specifications
💊 Drugs Class I - Dangerous
Superpotent Drug: products were found to be contaminated and above specification for lidocaine assay.
💊 Drugs Class I - Dangerous
Failed Impurities/Degradation Specifications
💊 Drugs Class I - Dangerous
Superpotent Drug: products were found to be contaminated and above specification for lidocaine assay.
💊 Drugs Class I - Dangerous
Failed Impurities/Degradation Specifications
💊 Drugs Class I - Dangerous
Failed Impurities/Degradation Specifications
💊 Drugs Class I - Dangerous
Superpotent Drug: products were found to be contaminated and above specification for lidocaine assay.
Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System, labeled as EMBLEM MRI S-ICD Pulse Generator
Boston Scientific
🏥 Medical Devices Class I - Dangerous
Potential need for device replacement - Elective Replacement Indicator (ERI) or End of Life (EOL) - earlier than expected due to compromised performance of an electrical component causing accelerated battery depletion.
Hemospray Endoscopic Hemostat
Wilson-Cook Medical
🏥 Medical Devices Class I - Dangerous
Potential for Hemospray device to be unable to spray powder due to misassembly of devices.
Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System, labeled as EMBLEMTM S-ICD Pulse Generator
Boston Scientific
🏥 Medical Devices Class I - Dangerous
Potential need for device replacement - Elective Replacement Indicator (ERI) or End of Life (EOL) - earlier than expected due to compromised performance of an electrical component causing accelerated battery depletion.
AD-TECH Drill Sleeve Guides, used with Ad-Tech Placement Kits: (a) REF DSG-90-2.3N (b) REF DSG-6.3-090-2.4N
Ad-Tech Medical Instrument
🏥 Medical Devices Class I - Dangerous
The inner diameter of the drill sleeve guide raw material was found to be under tolerance, potentially resulting in the drill bit seizing in the guide during surgery.
LEEP Return Patient Pads (10/ box) Model # 6050Pl used in electrosurgical procedures.
CooperSurgical
🏥 Medical Devices Class I - Dangerous
Discrepancy between the correct expiration dates on the individual pouches inside the boxes and incorrect expiration dates on the outer boxes, where the month and day were reversed.
🏥 Medical Devices Class I - Dangerous
Remote Antenna Cable Used with Philips MX4O Monitors Does Not Have the Required Rating for Some Installations
Maquet Cardiopulmonary (MCP)/Getinge HLS Set Advanced 7.0. Model Number BEQ-HLS-7050 USA, Part Number 701052794
Maquet Cardiovascular Us Sales
🏥 Medical Devices Class I - Dangerous
The sets are configured with quick connectors that have been assembled in reverse on the arterial and venous lines, resulting in blue (venous) to red (arterial) and red (arterial) to blue (venous) connections. Due to this incorrect assembly, the sets cannot be primed from the reservoir prior to use, and the device may not function as intended.