💊 Drugs Class I - Dangerous
CGMP Deviations
All Recalls
95,114 total recalls in our database
💊 Drugs Class I - Dangerous
CGMP Deviations
💊 Drugs Class I - Dangerous
Cross Contamination with other products: trace amounts of lidocaine
Imatinib Mesylate Tablets 100 mg, Rx Only, 90-count Bottle, Manufactured by: Shilpa Medicare Limited, India, Distributed by: Armas Pharmaceuticals Inc., Manalapan, NJ 07726, NDC 72485-202-90.
Shilpa Medicare Limited
💊 Drugs Class I - Dangerous
CGMP Deviations
💊 Drugs Class I - Dangerous
Lack of CGMPs:
MAC VU360, Electrocardiograph
GE Healthcare
🏥 Medical Devices Class I - Dangerous
Incorrect patient identification and/or patient demographic errors.
Instruction Manual for Mayfield A2000 Skull Cap - Product Usage: intended for or rigid skeletal fixation during neurosurgical procedures. P/N: 451A2000
Integra LifeSciences
🏥 Medical Devices Class I - Dangerous
Revised Instruction Manual to reflect the most accurate illustration for Mayfield Skull Clamp A2000 Position Diagram
Potential for Transcatheter Aortic Valve (TAV) leaflet damage when performing a post-implant balloon dilatation (PID).
MassChrom Amino Acid Analysis Plasma Control Level I, Order No. 0471 - Product Usage: The kit is intended for amino acid metabolic screening, confirmation of a tentative diagnosis, and monitoring of treatment in individuals diagnosed with a metabolic disorder.
Chromsystems Instruments & Chemicals GmbH
🏥 Medical Devices Class I - Dangerous
Products do not meet stability criteria and may impact results.
🏥 Medical Devices Class I - Dangerous
Potential exposure of product to microbial contamination.
🏥 Medical Devices Class I - Dangerous
All-in-One Tab Removal Tool may cause cracking and/or separating at the threaded interface between tool s metal shaft component and handle, resulting in leakage of Loctite from handle cracks
3PLUS1 Multilevel Plasma Calibrator Set, Order No. 75128 - Product Usage: The kit is intended for amino acid metabolic screening, confirmation of a tentative diagnosis, and monitoring of treatment in individuals diagnosed with a metabolic disorder.
Chromsystems Instruments & Chemicals GmbH
🏥 Medical Devices Class I - Dangerous
Products do not meet stability criteria and may impact results.
🏥 Medical Devices Class I - Dangerous
Detachment of the Male AIV Adaptor from the Y-Connector.
🏥 Medical Devices Class I - Dangerous
The firm has identified a problem with the control software for the celling arm of the X-Ray System . This software issue could cause the ceiling arm of the device to move after the operator has released the movement lever. This could result in possible collision or harm to the patient or system operator.
🏥 Medical Devices Class I - Dangerous
Potential exposure of product to microbial contamination.
🏥 Medical Devices Class I - Dangerous
There is a potential that the adjustable handle option on the X-Ray system may have been installed with improper bolts. This could result in improper driving operation which could lead to harm of individuals around the device.
🏥 Medical Devices Class I - Dangerous
Potential exposure of product to microbial contamination.
🏥 Medical Devices Class I - Dangerous
Potential for Transcatheter Aortic Valve (TAV) leaflet damage when performing a post-implant balloon dilatation (PID).
ELI 380 Electrocardiograph - Product Usage: intended to be a high-performance, multichannel resting electrocardiograph. As a resting electrocardiograph, the ELI 380 simultaneously acquires data from each lead.
WELCH ALLYN, INC/MORTARA
🏥 Medical Devices Class I - Dangerous
The radio within the device can become disassociated with the wireless access point.
MassChrom Amino Acid Analysis Plasma Control Level III, Order No. 0473 - Product Usage: The kit is intended for amino acid metabolic screening, confirmation of a tentative diagnosis, and monitoring of treatment in individuals diagnosed with a metabolic disorder.
Chromsystems Instruments & Chemicals GmbH
🏥 Medical Devices Class I - Dangerous
XXX