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All product recalls associated with Medtronic Sofamor Danek USA Inc.
Total Recalls
606
Past Year
25
Class I (Serious)
0
Most Recent
Nov 2025
Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.
The firm received complaints regarding the use of the product in patients with poor bone quality, translational instability, difficulty implanting the cover plate and case of cover plate detachment.
Medtronic is recalling one lot of STREAMLINE Bipolar Myocardial Temporary Pacing Leads, Model 6495, Lot JGD880205F. This lot of product contains incorrect inner pouch labeling, instead of 6495 it is labeled 6500. The outer carton, shelf box labeling, and instructions for use are correct, and the actual product shipped was consistent with the product ordered. No adverse patient effects have b
Product not sterile: 10 units were released for distribution without undergoing sterilization process.