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Medtronic Navigation, Inc. recalls RadiaLux Lighted Retractor (Pink), REF: 50-101-1
Recalled January 18, 2023 · FDA recall Z-0953-2023 · Medtronic Navigation
Hazard
Defect in sterile pouch seal, incomplete seal, of lighted Retractors, increases the risk of contamination, which can lead to post-operative infection. · FDA Class II
Units
2317
Sold at
US Nationwide distribution including in the states of OH, CA, FL, NJ, NY, MN, IN, VA, WA, MS, SC, MO, GA, PA, KS, TN, LA, TX, ME, MA, AL, NC, MD, NH, IL, AZ, MI, NV, MT, OK, SD, RI, CO, CT, NM, NE, DE, WI.
Description
Defect in sterile pouch seal, incomplete seal, of lighted Retractors, increases the risk of contamination, which can lead to post-operative infection.
Product
RadiaLux Lighted Retractor (Pink), REF: 50-101-1
Manufacturer(s)
Medtronic Navigation, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →