The oxygen and air wall inlet fittings and/or labels on the back panel of the resuscitation systems may have been reversed during assembly, potentially reversing the air/oxygen concentrations... Lumenis VersaCut Tissue Morcellator: Class I Recall
Recall due to labeling correction of certain models, potential for air embolisms to occur if the aspiration tubing is hooked up backwards to the aspiration control box housing...Ad-Tech Macro Micro Subdural Electrodes: Class I Recall
Potential for abrasion of brain tissue and for broken pieces to remain in the brain tissue when the physician removes the electrode...
St. Jude Medical, AMPLATZER TorqVue FX Delivery System: Class I Recall
In a small number of cases, the distal end of the core wire of the TorqVue FX Delivery System could potentially fracture when exposed to a combination of certain cardiac anatomies and usage conditions...
DePuy Orthopaedics LPS Diaphyseal Sleeve: Class I Recall
The LPS diaphyseal sleeve to diaphyseal sleeve base taper connection may not be sufficient to accommodate potential physiologic loads that may be transferred to the junction during normal gait activities by some patients...
Extreme Weather Effects on Medical Device Safety and Quality - Federal Register Notice
FDA is studying the potential effects of extreme weather and natural disasters on medical device safety and quality and is requesting for comments on this topic...
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