Open, Classified

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

FDA Recall Z-0953-2023 · Posted 2023-01-12

Recalling FirmMedtronic Navigation, Inc.

Recall StatusOpen, Classified

Product CodeGAD

Date Initiated2022-12-08

Product Quantity2317

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.

Firm Action

On 11/17/22 customers were verbally notified to quarantine affected devices. On 12/08/22, recall notices were sent to customers asking them to take the following action: 1) Discontinue use of affected devices. 2) Return affected devices to the recalling firm. 3) Complete and return the customer confirmation form that can be emailed to [email protected] 3) The notice needs to be shared with all who need to be aware within your organization and any organization where the potentially affected devices have been transferred. Customers with questions are encouraged to call/email: Medtronic Technical Services at 1-888-826-5603/[email protected]

Root Cause

Equipment maintenance

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.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.