💊 Drugs Class I - Dangerous
Lack of Assurance of Sterility
All Recalls
95,114 total recalls in our database
💊 Drugs Class I - Dangerous
CGMP Deviations
💊 Drugs Class I - Dangerous
Lack of Assurance of Sterility
Pioglitazone Tablets USP, 45 mg, 500 count bottles, Distributed by: Aurobindo Pharma USA, Inc., East Windsor, NJ -- NDC 57237-221-05
Aurobindo Pharma USA
💊 Drugs Class I - Dangerous
Superpotent and Failed Tablet/Capsule Specifications
💊 Drugs Class I - Dangerous
CGMP Deviations
💊 Drugs Class I - Dangerous
cGMP deficiencies
💊 Drugs Class I - Dangerous
Lack of Assurance of Sterility
🏥 Medical Devices Class I - Dangerous
Philips has identified a specific lot of non-conforming material manufactured by one of its suppliers. A Philips supplier incorrectly used polyester-based polyurethane (PE-PUR) sound abatement foam, a non-conforming material in the devices and repair kits. PE-PUR foam may degrade into particles which may enter the device s air pathway and be ingested or inhaled by the user. The foam degradation may be exacerbated by use of unapproved cleaning methods such as unapproved ozone cleaners, and the PE-PUR foam may off-gas certain chemicals during initial use of the device.
🏥 Medical Devices Class I - Dangerous
The firm identified that the Vscan Extend device will not power on because of depleted battery, due to the device not being turned off prior to battery removal or when being connected to a computer without AC power.
GE Vscan Extend, being sold as "Vscan Extend Dual USB"
GE Healthcare
🏥 Medical Devices Class I - Dangerous
The firm identified that the Vscan Extend device will not power on because of depleted battery, due to the device not being turned off prior to battery removal or when being connected to a computer without AC power.
Artis pheno with software VE20C- diagnostic imaging angiography system Model: 10849000
Siemens Medical Solutions USA
🏥 Medical Devices Class I - Dangerous
Four potential software issues with Artis pheno and Artis icono systems with software VE20C: 1. Updated calibration data not saved with measurement after scene+/-; 2. No x-ray possible, system shutdown/restart might be required during intervention; 3. Corrupted Image during Roadmap; 4. Unintended shutdown of Imaging System with UPS (Uninterruptable Power Supply) option
GE Vscan Extend, being sold as "Vscan Extend Dual Wi-Fi"
GE Healthcare
🏥 Medical Devices Class I - Dangerous
The firm identified that the Vscan Extend device will not power on because of depleted battery, due to the device not being turned off prior to battery removal or when being connected to a computer without AC power.
Artis icono biplane with software VE20C-diagnostic imaging angiography system Model: 11327600
Siemens Medical Solutions USA
🏥 Medical Devices Class I - Dangerous
Four potential software issues with Artis pheno and Artis icono systems with software VE20C: 1. Updated calibration data not saved with measurement after scene+/-; 2. No x-ray possible, system shutdown/restart might be required during intervention; 3. Corrupted Image during Roadmap; 4. Unintended shutdown of Imaging System with UPS (Uninterruptable Power Supply) option
GE Vscan Extend, being sold as "Vscan Extend Sector USB"
GE Healthcare
🏥 Medical Devices Class I - Dangerous
The firm identified that the Vscan Extend device will not power on because of depleted battery, due to the device not being turned off prior to battery removal or when being connected to a computer without AC power.
🏥 Medical Devices Class I - Dangerous
The firm identified that the Vscan Extend device will not power on because of depleted battery, due to the device not being turned off prior to battery removal or when being connected to a computer without AC power.
GE Vscan Extend, being sold as "Vscan Extend Console"
GE Healthcare
🏥 Medical Devices Class I - Dangerous
The firm identified that the Vscan Extend device will not power on because of depleted battery, due to the device not being turned off prior to battery removal or when being connected to a computer without AC power.
Artis icono floor with software VE20C-diagnostic imaging angiography system Model: 11327700
Siemens Medical Solutions USA
🏥 Medical Devices Class I - Dangerous
Four potential software issues with Artis pheno and Artis icono systems with software VE20C: 1. Updated calibration data not saved with measurement after scene+/-; 2. No x-ray possible, system shutdown/restart might be required during intervention; 3. Corrupted Image during Roadmap; 4. Unintended shutdown of Imaging System with UPS (Uninterruptable Power Supply) option
🏥 Medical Devices Class I - Dangerous
Risk of misidentification or delayed results with the absence of identification due to thermoforming defect.
🏥 Medical Devices Class I - Dangerous
Friction rubber block in the clamping mechanism was missing in the Footrest. It may slip down along the patient table while in use with a patient. This accessory is designed to use with Intelli-C, Right and Intelli-C, Left.
🏥 Medical Devices Class I - Dangerous
The firm is reinforcing the IFU instructions: "Do not use if the package is damaged." If upon inspection of the packaging, any damage is observed, including pinholes or tears in the pouch, the product should not be used.