💊 Drugs Class I - Dangerous
Lack of assurance of sterility: Potential channel leaks near the threaded vial port.
All Recalls
95,114 total recalls in our database
💊 Drugs Class I - Dangerous
Failed Impurities/Degradation Specifications: failed specification for unknown impurity at the 24 month stability testing.
🏥 Medical Devices Class I - Dangerous
A single distributed ZNN Greater Trochanter Femoral Nail may have been dented. Potential for fatigue of implant prior to sufficient fracture healing, which may result in need for implant removal and revision of fracture fixation to assure proper healing and avoid fracture malunion or nonunion.
Sorin Stockert Heater-Cooler 3T, 120 V / 60 Hz Temperature control for extracorporeal perfusion of durations up to 6 hours.
Sorin Group USA
🏥 Medical Devices Class I - Dangerous
Potential colonization of organisms, including Mycobacteria, in Sorin Heater Cooler Devices, if proper disinfection and maintenance is not performed per Instructions for Use.
🏥 Medical Devices Class I - Dangerous
Incorrect thread form on the screw.
🏥 Medical Devices Class I - Dangerous
The dials in the Autopens are not working - the dial does not stay dialed, but springs right back to 0. As a result, the patient could not dial up a dose of medicine to deliver via an injection.
🏥 Medical Devices Class I - Dangerous
One dimension of the affected instrument is incorrect. Therefore this instrument cannot be used to remove the metal adapter as intended.
🏥 Medical Devices Class I - Dangerous
Accessories to the GYC-1000 laser were missing Laser Aperture labels.
🏥 Medical Devices Class I - Dangerous
Product may breach the inner and outer sterile pouches during shipping or handling.
🏥 Medical Devices Class I - Dangerous
Shipped to a single consignee prior to completion of final inspection.
🏥 Medical Devices Class I - Dangerous
EIZO is recalling the RadiForce LCD Monitors could display abnormally while connecting to particular graphics boards with DisplayPort.
🏥 Medical Devices Class I - Dangerous
Sterile packaging was not sealed. The implantation of an unsterile screw may lead to infection.
🏥 Medical Devices Class I - Dangerous
The G7 Variant Elution Buffer HiS no. 1 (M) is incorrectly labeled with an expiration date of October 2015. The correct expiration date is October 2014.
Sorin Stockert Heater-Cooler 3T, 230 V Temperature control for extracorporeal perfusion of durations up to 6 hours.
Sorin Group USA
🏥 Medical Devices Class I - Dangerous
Potential colonization of organisms, including Mycobacteria, in Sorin Heater Cooler Devices, if proper disinfection and maintenance is not performed per Instructions for Use.
Allofix Insertion Kit, 2.0 mm, Single Drill, Product Usage: MTF Surgical Instruments are designed for the specific needs of the orthopedic surgeon and are intended to be used in conjunction with the associated allograft. This kit is for single use only.
Musculoskeletal Transplant Foundation
🏥 Medical Devices Class I - Dangerous
Musculoskeletal Transplant Foundation is recalling a certain lot of Allofix Insertion Kits because they are labeled as having a 2.0mm diameter drill however it may contain a 2.4 mm diameter drill.
🏥 Medical Devices Class I - Dangerous
A problem exists in MOSAIQ resulting in the incorrect field size being sent to the treatment machine for stereotactic plans using cones.
Shipped to a single consignee prior to completion of final inspection.
🏥 Medical Devices Class I - Dangerous
Inadequate curing of adhesive, may cause the two halves of the spheres to separate.
🏥 Medical Devices Class I - Dangerous
It was reported that the RIA Drive Shaft, Tube Assembly, and Reamer Head have the potential to break when incorrectly assembled or used improperly. Precautionary statements are being added to the Reamer / Irrigator / Aspirator (RIA) Surgical Technique Guide .
🏥 Medical Devices Class I - Dangerous
EIZO is recalling the RadiForce LCD Monitors could display abnormally while connecting to particular graphics boards with DisplayPort.