Lower risk Medical device recall · FDA · Published December 8, 2022

Medtronic RadiaLux Lighted Retractor Recall: Contamination Risk

Medtronic recalls pink RadiaLux Lighted Retractors with specific serial numbers due to potential contamination risk leading to post-operative infections. Affected units may need replacement.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-0953-2023Medical device Medtronic ›

Lower-risk recall

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

Take action

Contact the company

Recalling firmMedtronic Navigation, Inc.826 Coal Creek Cir · Louisville, CO 80027-9710

✎ GovInfoNow plain-language explainer

Medtronic is recalling pink RadiaLux Lighted Retractors with certain serial numbers because a defect in the sterile pouch seal could cause contamination. This increases the risk of post-operative infections for patients who have or will have surgery using these retractors. Read more at govinfonow.com/recall/59187-medtronic-radialux-lighted-retractor-recall-contamination-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/59187-medtronic-radialux-lighted-retractor-recall-contamination-risk · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0953-2023

Cite this page

“Medtronic RadiaLux Lighted Retractor Recall: Contamination Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/59187-medtronic-radialux-lighted-retractor-recall-contamination-risk. Based on FDA recall #Z-0953-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0953-2023%22&limit=1).

The FDA announced on Dec. 8, 2022, that Medtronic Navigation, Inc. is recalling RadiaLux Lighted Retractors (Pink) due to a defective sterile pouch seal that increases the risk of contamination and post-operative infection. This voluntary Class II recall affects 2,317 units distributed nationwide.

How to tell if you have it

Brand: Medtronic
Product: RadiaLux Lighted Retractor (Pink)
REF: 50-101-1
UDI-DI/Lot: 00763000432805/ 705F, 706F, 707F, 708F, 709F

The hazard

The recall addresses a defect in the sterile pouch seal of the lighted retractors. This incomplete seal increases the risk of contamination, which can lead to post-operative infection.

Context

GovInfoNow's records show Medtronic Navigation, Inc. has 25 other recalls on record since June 7, 2017. Recent issues include a Dec. 4, 2024, recall of PIN surgical pins that may not fit patient reference frames and an Aug. 22, 2024, recall of StealthStation S8 App versions 1.3.0 and 1.3.2 due to software anomalies. Other recent recalls of similar products include Medtronic DLP Retrograde Cannula Recall (April 21, 2026), Medtronic GUNDRY Cannula Recall (April 21, 2026), and Medtronic DLP Cannula Recall (April 21, 2026).

How to tell if you have this one

Check for the pink color and the specific serial numbers: 00763000432805/ 705F, 706F, 707F, 708F, 709F. These units were sold with the reference number 50-101-1.

Brand
Medtronic
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Product Serial Number
Look for the serial numbers 00763000432805 or 705F through 709F on the product.

Where it went and when

Where it was distributed

Distributed nationwide; the notice names 38 states.

FDA distribution: “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.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Alabama, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Illinois, Indiana, Kansas, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, Ohio, Oklahoma, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Virginia, Washington, Wisconsin.

Recall timeline

FDA published this recall 41 days after the firm started it.

Dec 8, 2022Firm started the recall
Jan 12, 2023FDA classified it Class II
Jan 18, 2023Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/59187-medtronic-radialux-lighted-retractor-recall-contamination-risk">Medtronic RadiaLux Lighted Retractor Recall: Contamination Risk (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-0953-2023 (December 8, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0953-2023 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.