🏥 Medical Devices Class I - Dangerous
Tri-Ball Tunneler may contain loosely affixed metal shavings, potential for the metal shaving to embolize, possibly requiring removal via surgical procedure.
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95,083 total recalls in our database
🏥 Medical Devices Class I - Dangerous
Tri-Ball Tunneler may contain loosely affixed metal shavings, potential for the metal shaving to embolize, possibly requiring removal via surgical procedure.
Clinical Chemistry Calibration Serum (Catalog number Cal2351) that is 20x5ml lyophilized human based serum covering 38 commonly used clinical chemistry tests.
Randox Laboratories
🏥 Medical Devices Class I - Dangerous
Randox Laboratories has identified that Inorganic Phosphate in Calibration Serum Level 3, CAL2351 & CAL10388, is running with a negative bias on RX Series instruments compared to other methods.
🏥 Medical Devices Class I - Dangerous
Tri-Ball Tunneler may contain loosely affixed metal shavings, potential for the metal shaving to embolize, possibly requiring removal via surgical procedure.
GE Healthcare Allia IGS 5 Pulse, Interventional fluoroscopic x-ray systems
GE Medical Systems, SCS
🏥 Medical Devices Class I - Dangerous
GE HealthCare has become aware of the potential that adhesive material might not have been applied to some bolts of certain Innova IGS, Discovery IGS, Interact IGS, Allia IGS and Allia Pulse IGS products. This could result in a potential fall of the Detector/Elevator or X-ray tube of the frontal Gantry assembly.
🏥 Medical Devices Class I - Dangerous
Tri-Ball Tunneler may contain loosely affixed metal shavings, potential for the metal shaving to embolize, possibly requiring removal via surgical procedure.
GE Healthcare Innova IGS 5, computed tomography x-ray system
GE Medical Systems, SCS
🏥 Medical Devices Class I - Dangerous
GE HealthCare has become aware of the potential that adhesive material might not have been applied to some bolts of certain Innova IGS, Discovery IGS, Interact IGS, Allia IGS and Allia Pulse IGS products. This could result in a potential fall of the Detector/Elevator or X-ray tube of the frontal Gantry assembly.
GE Healthcare Allia IGS 7, Interventional fluoroscopic x-ray systems
GE Medical Systems, SCS
🏥 Medical Devices Class I - Dangerous
GE HealthCare has become aware of the potential that adhesive material might not have been applied to some bolts of certain Innova IGS, Discovery IGS, Interact IGS, Allia IGS and Allia Pulse IGS products. This could result in a potential fall of the Detector/Elevator or X-ray tube of the frontal Gantry assembly.
🏥 Medical Devices Class I - Dangerous
Tri-Ball Tunneler may contain loosely affixed metal shavings, potential for the metal shaving to embolize, possibly requiring removal via surgical procedure.
GE Healthcare Innova IGS 6, Interventional fluoroscopic x-ray systems
GE Medical Systems, SCS
🏥 Medical Devices Class I - Dangerous
GE HealthCare has become aware of the potential that adhesive material might not have been applied to some bolts of certain Innova IGS, Discovery IGS, Interact IGS, Allia IGS and Allia Pulse IGS products. This could result in a potential fall of the Detector/Elevator or X-ray tube of the frontal Gantry assembly.
🏥 Medical Devices Class I - Dangerous
Ultrasound system with: 1) transesophageal echocardiography transducer (TEE) connected/not selected 2) 1, 2 non-TEE connected 3) Imaging with non-TEE 4) Selected/not selected imaging transducer removed 5) Transducer connected 6) Non-TEE imaging continues, Then though TEE is unselected, it may have power, no temperature monitoring/control, and may result in temperature above limit and patient burns
GE Healthcare Allia IGS 5 Pulse, Interventional fluoroscopic x-ray systems
GE Medical Systems, SCS
🏥 Medical Devices Class I - Dangerous
GE HealthCare has become aware of the potential that adhesive material might not have been applied to some bolts of certain Innova IGS, Discovery IGS, Interact IGS, Allia IGS and Allia Pulse IGS products. This could result in a potential fall of the Detector/Elevator or X-ray tube of the frontal Gantry assembly.
🏥 Medical Devices Class I - Dangerous
Tri-Ball Tunneler may contain loosely affixed metal shavings, potential for the metal shaving to embolize, possibly requiring removal via surgical procedure.
Baxter Spectrum IQ Infusion Pump, Product Code 3570009
Baxter Healthcare
🏥 Medical Devices Class I - Dangerous
One device was improperly performed testing prior to release from a Service Center.
🏥 Medical Devices Class I - Dangerous
Due to a software issue, there is the potential for a missing digit, letter, or decimal in either the "distance to target" or "tip stop point" display during navigation.
Stryker 1,5/1,7MM DYNAMIC MESH- STD-MEDIUM-Intended for the reconstruction, stabilization and rigid fixation of the bony areas of the cranial skeleton. Catalog Number: 56-90614
Stryker Leibinger GmbH & Co. KG
🏥 Medical Devices Class I - Dangerous
Mislabeled: Product labeled 56-90614 (90x90 Gold Mesh), was actually 56-90314 (90x90 Blue Mesh), may cause a delay in procedure
🏥 Medical Devices Class I - Dangerous
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Zegoo Children's Nightgowns
Unknown Manufacturer
🏠 Consumer Products Class II - Moderate
The children's nightgowns violate the flammability standards for children's sleepwear, posing a risk of burn injuries to children.
SIORO Children's Robes
Unknown Manufacturer
🏠 Consumer Products Class II - Moderate
The children's robes violate the flammability standards for children's sleepwear, posing a risk of burn injuries to children.
Toy Pinwheels
Unknown Manufacturer
🏠 Consumer Products Class II - Moderate
The pinwheel's fastener cap can come loose and detach, posing a choking hazard to young children.