Intellis AdaptiveStim Product Number 97715, Spinal Cord Stimulator
Medtronic Neuromodulation
🏥 Medical Devices Class I - Dangerous
inability to reprogram one device
All Recalls
95,114 total recalls in our database
RayStation 12.0.0.932, 12.1.0.1221, 12.0.3.68, 12.0.4.12 &12.3.0.119. Radiation Therapy Treatment Planning System.
RAYSEARCH LABORATORIES AB
🏥 Medical Devices Class I - Dangerous
Potential for reported SSD to be too high.
🏥 Medical Devices Class I - Dangerous
Thread form issue for the locking holes in that the locking screws may not properly mate with the plate. The improperly mated screw may not be readily recognizable by the user since the screw may not correctly lock, may result in delay in surgery or loss of fixation resulting further intervention
IPS e.max ZirCAD CER/in. Prime B1 C17/5 -A zirconium oxide block for the fabrication of fixed, full-contour restorations in anterior and posterior teeth. Article Number: 758441
IVOCLAR VIVADENT AG
🏥 Medical Devices Class I - Dangerous
Defective blocks may show cracks after sintering If cracks are unnoticed, restorations may fracture in the patient's mouth and require restoration
🏥 Medical Devices Class I - Dangerous
Thread form issue for the locking holes in that the locking screws may not properly mate with the plate. The improperly mated screw may not be readily recognizable by the user since the screw may not correctly lock, may result in delay in surgery or loss of fixation resulting further intervention
🏥 Medical Devices Class I - Dangerous
Thread form issue for the locking holes in that the locking screws may not properly mate with the plate. The improperly mated screw may not be readily recognizable by the user since the screw may not correctly lock, may result in delay in surgery or loss of fixation resulting further intervention
🏥 Medical Devices Class I - Dangerous
One lot of product was exposed to more than the approved number of Ethylene Oxide (EO) sterilization cycles. This may decrease the tensile strength of the sutures over time, which could result in harms such as wound dehiscence, hemorrhage, blood loss, bleeding, tissue breakdown, peritonitis, unspecified infection, vision loss (when used in ophthalmic application), and/or prolonged surgery.
IPS e.max ZirCAD CER/in. Prime A1 C17/5 - A zirconium oxide block for the fabrication of fixed, full-contour restorations in anterior and posterior teeth. Article Number: 758437
IVOCLAR VIVADENT AG
🏥 Medical Devices Class I - Dangerous
Defective blocks may show cracks after sintering If cracks are unnoticed, restorations may fracture in the patient's mouth and require restoration
RayStation 14.0.0.3338. Radiation Therapy Treatment Planning System.
RAYSEARCH LABORATORIES AB
🏥 Medical Devices Class I - Dangerous
Potential for reported SSD to be too high.
RayStation 9.1.0.933 and 9.2.0.483. Radiation Therapy Treatment Planning System.
RAYSEARCH LABORATORIES AB
🏥 Medical Devices Class I - Dangerous
Potential for reported SSD to be too high.
POWERSEAL 5 mm, 23 cm, Curved Jaw Sealer and Divider, Double Action is indicated for use in general surgery and such surgical specialties as urologic, colorectal, bariatric, vascular, thoracic, and gynecologic. Model/Catalog Number: PS-0523CJDA
Olympus Corporation of the Americas
🏥 Medical Devices Class I - Dangerous
Upon initial activation of the seal function, the POWERSEAL non-conformance results in an immediate Incomplete Seal Cycle tone with the accompanying message on the generator screen, and no energy would be delivered to the device resulting in delay in surgery.
🏥 Medical Devices Class I - Dangerous
Potential for a leak path at the seal interface between the left ventricle assist system inflow cannula and the titanium apical cuff.
POWERSEAL 5 mm, 37 cm, Curved Jaw Sealer and Divider, Double Action is indicated for use in general surgery and such surgical specialties as urologic, colorectal, bariatric, vascular, thoracic, and gynecologic. Model/Catalog Number: PS-0537CJDA
Olympus Corporation of the Americas
🏥 Medical Devices Class I - Dangerous
Upon initial activation of the seal function, the POWERSEAL non-conformance results in an immediate Incomplete Seal Cycle tone with the accompanying message on the generator screen, and no energy would be delivered to the device resulting in delay in surgery.
🏥 Medical Devices Class I - Dangerous
Thread form issue for the locking holes in that the locking screws may not properly mate with the plate. The improperly mated screw may not be readily recognizable by the user since the screw may not correctly lock, may result in delay in surgery or loss of fixation resulting further intervention
🏥 Medical Devices Class I - Dangerous
Thread form issue for the locking holes in that the locking screws may not properly mate with the plate. The improperly mated screw may not be readily recognizable by the user since the screw may not correctly lock, may result in delay in surgery or loss of fixation resulting further intervention
Abbott Aveir Leadless Pacemaker, REF: LSP112V, STERILEEO
Abbott Medical
🏥 Medical Devices Class I - Dangerous
Their is a potential that electromagnetic interference may cause leadless pacemaker may result in mode change.
🏥 Medical Devices Class I - Dangerous
Thread form issue for the locking holes in that the locking screws may not properly mate with the plate. The improperly mated screw may not be readily recognizable by the user since the screw may not correctly lock, may result in delay in surgery or loss of fixation resulting further intervention
Honda Lawnmowers, Replacement Engines, and Pressure Washers Engines
American Honda Motor Co. Inc., of Torrance, California
🏠 Consumer Products Class II - Moderate
The improperly manufactured camshafts in the engines can cause the starter rope to suddenly retract when pulling to start, posing an injury hazard.
Arctic Cat 8000 and 9000 Series Snowmobiles
Arctic Cat, of Thief River Falls, Minnesota
🏠 Consumer Products Class III - Low Risk
The recalled snowmobile's drive clutch can break, allowing fragments to escape the snowmobile shielding, posing a laceration hazard.
Project Watson Eyelid Wipes for Dogs
Unknown Manufacturer
🏠 Consumer Products Class II - Moderate
When the recalled dog eyelid wipes are opened and in use, bacteria and fungi, which are organisms found widely in the environment, soil, and water, can be introduced and grow in the container, posing a risk of serious infection to people with weakened immune systems. Individuals with wounds may also be at higher risk of infection. People with healthy immune systems are not typically affected.