💊 Drugs Class I - Dangerous
Product Mix Up. A bottle labeled as Phenazopyridine HCl tablets USP 100 mg contained Phenobarbital tablets 16.2 mg.
All Recalls
95,114 total recalls in our database
💊 Drugs Class I - Dangerous
Lack of Assurance of Sterility
💊 Drugs Class I - Dangerous
Defective Container
Preview Strep A, Streptococcal A rapid test kits, Part Numbers: a) PRE-STA-25, b) PRE-STA-A-10
Wondfo USA Co
🏥 Medical Devices Class I - Dangerous
Wondfo USA has identified unauthorized distribution of the Preview Strep A Test Kit. Unauthorized distribution of this device would include sales and distribution of this test for at-home use, non-prescription use, over-the-counter use, or direct-to-consumer customers.
🏥 Medical Devices Class I - Dangerous
Wondfo USA has identified unauthorized distribution of the Preview Strep A Test Kit. Unauthorized distribution of this device would include sales and distribution of this test for at-home use, non-prescription use, over-the-counter use, or direct-to-consumer customers.
OMTech Desktop Laser Engraver
Rygel Advanced Machines d/b/a Omtech Laser
🏥 Medical Devices Class I - Dangerous
Lack of redundant interlocks, missing required labels and certification labels as required by 21 1010.2.
🏥 Medical Devices Class I - Dangerous
Wondfo USA has identified unauthorized distribution of the Preview Strep A Test Kit. Unauthorized distribution of this device would include sales and distribution of this test for at-home use, non-prescription use, over-the-counter use, or direct-to-consumer customers.
🏥 Medical Devices Class I - Dangerous
The devices are labeled "not made with DEHP" or the DEHP free symbol; however, the glue used contains traces of DEHP.
🏥 Medical Devices Class I - Dangerous
Due to saline conductivity issues, their is a potential that dilation catheters may provide inaccurate esophageal diameter measurements that may lead to various harms.
The expiration date was not printed on the outer shipping label, leading to expired syringes being shipped to customers.
🏥 Medical Devices Class I - Dangerous
Possibility of the robotic arm to drop more than 10cm from its original position after pressing the emergency stop button due to failure of the integrated safety mechanism.
Coviden Monoject 60ml Syringe Luer-Lock Tip-used to inject fluid into or withdraw fluids from the body MMS Catalog Number: 1159851 Cardinal Catalog Number: 8881560125
Mckesson Medical-Surgical Inc. Corporate Office
🏥 Medical Devices Class I - Dangerous
Quarantined product was inadvertently distributed
MRI systems: Vantage Orian MRT-1550 (MEXL-1550), Vantage Elan MRT-2020 (MEXL-1520), Vantage Titan MRT-1504 (MEXL-1504), Vantage Titan 3T MRT-3010 (MEXL-3010), Vantage Galan 3T MRT-3020 (MEXL-3020)
Canon Medical System, USA
🏥 Medical Devices Class I - Dangerous
The terminal block used to secure the power supply cable for the gradient coil of the MRI system was not secured as designed, which could cause cable disconnection, which could lead to arcing, followed by melting of the cable, ignition, smoke, and fire.
The expiration date was not printed on the outer shipping label, leading to expired syringes being shipped to customers.
🏥 Medical Devices Class I - Dangerous
CORI Surgical System with Real Intelligence Software exhibits an increased Marker Registration Error (MRE) which may cause tracker arrays to flicker on screen of the CORI Surgical System during use, and may cause surgical delay
🏥 Medical Devices Class I - Dangerous
Wondfo USA has identified unauthorized distribution of the Preview Strep A Test Kit. Unauthorized distribution of this device would include sales and distribution of this test for at-home use, non-prescription use, over-the-counter use, or direct-to-consumer customers.
🏥 Medical Devices Class I - Dangerous
The devices are labeled "not made with DEHP" or the DEHP free symbol; however, the glue used contains traces of DEHP.
Darby Prophylaxis Paste with 1.23% Fluoride Ion, Mint Coarse
Young Dental Manufacturing I
🏥 Medical Devices Class I - Dangerous
Part number 040032, Lot number, 248607 was incorrectly labeled as part number 045032
US AquaA 900H-Typ USA-3 x 208v-Intended for the purification of water to be used for hemodialysis Vivonic Part Numbers: G02020110 Fresenius Part Number: 24-090A-1
Fresenius Medical Care Holdings
🏥 Medical Devices Class I - Dangerous
Concentrate Flow was exceeding the maximum 19.9 bar set point. The standard default set point range is between 4 and 18.Error message (F020104, "concentrate pressure alarm limit exceeded") concentrate pressure is too high and stops the dialysis water supply.
🏥 Medical Devices Class I - Dangerous
Wondfo USA has identified unauthorized distribution of the Preview Strep A Test Kit. Unauthorized distribution of this device would include sales and distribution of this test for at-home use, non-prescription use, over-the-counter use, or direct-to-consumer customers.