💊 Drugs Class I - Dangerous
CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.
All Recalls
95,050 total recalls in our database
💊 Drugs Class I - Dangerous
CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.
💊 Drugs Class I - Dangerous
CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.
Mometasone Furoate Cream, 0.1%, 45 g tube, Rx Only, Manufactured by: G&W Laboratories, Inc. South Plainfield, NJ 07080, NDC 0713-0726-37
ACP Nimble Buyer
💊 Drugs Class I - Dangerous
Labeling: Not Elsewhere Classified. Mometasone Furoate Cream has an NDC typographical error.
💊 Drugs Class I - Dangerous
Lack of assurance of sterility.
💊 Drugs Class I - Dangerous
CGMP Deviations
Randox CALCIUM (Ca) Colorimetric Method RX Series Cat. No. CA 3871, R1. Arsenazo Reagent 9 x 51ml GTIN: 05055273200904
Randox Laboratories
🏥 Medical Devices Class I - Dangerous
Update to the carryover avoidance technical bulletin to introduce additional steps for reagent carryover avoidance with the Calcium assay on RX instruments. Carryover to the Calcium reagent results may result in falsely elevated or decreased results to both patient and QC samples.
Medtronic Power Supply 26907, Medtronic CareLink Encore(TM) 29901 Programmer
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
🏥 Medical Devices Class I - Dangerous
There is a potential for an electrical short circuit to develop in a subset of 479 Model 26907 power supply cable plugs that connect to the Medtronic Model 29901 CareLink Encore programmer. A failure mode of the power supply has been found where an electrical short occurs on the low voltage direct current connector and results in the connector heating up, generating smoke, melting and in some cases disconnecting from the programmer.
🏥 Medical Devices Class I - Dangerous
The povidone iodine prep pads packaged with the arterial blood sampling kits will not maintain the iodine potency through its labeled 36-month expiration dating.
PageWriter TC70, Product 860315, Software revisions up to and including A.07.05.22 used to evaluate the electrocardiogram of adult and pediatric patients
Philips North America
🏥 Medical Devices Class I - Dangerous
Philips PageWriter TC cardiograph batteries which have reached end of life may overheat, causing the case to melt and/or the device to ignite, which can cause injury to patient or nearby users.
PageWriter TC50, Product 860310, Software revisions up to and including A.07.05.22 used to evaluate the electrocardiogram of adult and pediatric patients
Philips North America
🏥 Medical Devices Class I - Dangerous
Philips PageWriter TC cardiograph batteries which have reached end of life may overheat, causing the case to melt and/or the device to ignite, which can cause injury to patient or nearby users.
🏥 Medical Devices Class I - Dangerous
The povidone iodine prep pads packaged with the arterial blood sampling kits will not maintain the iodine potency through its labeled 36-month expiration dating.
🏥 Medical Devices Class I - Dangerous
Potential for the software on Automated PD System cyclers which can cause shortened dwell times during a Cycle-Based therapy
TRINIAS for diagnostic imaging and interventional procedures in cardiac angiography, neurovascular angiography, abdominal angiography, peripheral angiography, rotational angiography, multi-purpose angiography and whole body radiographic/fluoroscopic procedures.
Shimadzu Medical Systems Usa Com
🏥 Medical Devices Class I - Dangerous
Two issues: Event 1: Normal operation of the device is to power up the device in the morning, register the first patient, and then perform a fluoroscopy. If, however, the user powers up the device in the morning and makes an error by starting a fluoroscopy while the first patient is still being registered, the device application will abnormally terminate and require service intervention before it can be used again. This event will not occur after the first patient procedure. Event 2: In rare cases a synchronization error may occur in the data transmission circuit in the device due to external noise. The visibility of the displayed image may be corrupted (images become bit-shifted abnormal images). If this event occurs, it may become difficult to see the object, which may hinder the examination and treatment.
🏥 Medical Devices Class I - Dangerous
The products were manufactured with longer than specified sheaths.
🏥 Medical Devices Class I - Dangerous
Potential for the software on Automated PD System cyclers which can cause shortened dwell times during a Cycle-Based therapy
Pilling COOLEY SUMP-SUCTION TUBE, REF 351547
Teleflex Medical
🏥 Medical Devices Class I - Dangerous
The internal tip is missing from the device, causing the device to not function as intended.
🏥 Medical Devices Class I - Dangerous
A stability issue in the calibrators may cause calibration failures or atypical Quality Control results following a successful calibration.
VITEK 2 AST-N351 Test Kit
bioMerieux
🏥 Medical Devices Class I - Dangerous
False Positive ESBL Phenotype
🏥 Medical Devices Class I - Dangerous
A batch of 185cm Stingray Guidewires are incorrectly labeled as 300cm guidewires.