Medtronic Navigation, Inc.: Medical Device Recall in 2023 - (Recall #: Z-0953-2023)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.

Product Description:

RadiaLux Lighted Retractor (Pink), REF: 50-101-1

Product Classification:

Class II

Date Initiated: December 8, 2022

Date Posted: January 18, 2023

Recall Number: Z-0953-2023

Event ID: 91328

Reason for Recall:

Defect in sterile pouch seal, incomplete seal, of lighted Retractors, increases the risk of contamination, which can lead to post-operative infection.

Status: Ongoing

Product Quantity: 2317

Code Information:

UDI-DI/Lot: 00763000432805/ 705F, 706F, 707F, 708F, 709F

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated