RadiaLuxRecalls & reported problems across all models

We found 3 models of RadiaLux by Medtronic Navigation, Inc. in the FDA's device registry (GUDID). Together they are named in 8 adverse event reports in the FDA's MAUDE database, received between Nov 24, 2020 and Apr 10, 2026 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Break” (3 reports).

1 FDA recall record name at least one of these models by its device identifier, 1 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

RadiaLux recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Dec 8, 2022Open, Classified

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

   Z-0953-2023 · Root cause: Equipment maintenance · Recall details · FDA record ↗

Most reported RadiaLux problems

RadiaLux models

3 models, most reported first. Each model has its own page with its reports, recalls and device details.

• RadiaLux™ 50-101-1

  RETRACTOR
  1 recall2 reports
• RadiaLux™ 50-101-1

  RETRACTOR
  5 reports
• RadiaLux™ 50-101-1

  RETRACTOR
  1 report

Recent RadiaLux adverse event reports

The 8 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionApr 10, 2026Mechanical Problem

  ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THE DEBRIS WAS FOUND ONLY IN THE HANDPIECE PACKAGING WHICH WAS NEVER OPENED, NO DAMAGE TO THE INSTRUMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24845024 ↗
• MalfunctionNov 13, 2025Device Damaged Prior to Use; Device Contamination with Chemical or Other Material; Device Damaged Prior to Use; Device Contamination with Chemical or Other Material

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A HANDPIECE. IT WAS REPORTED THAT A HANDPIECE WAS FOUND TO HAVE A BROWN SUBSTANCE ON IT IMMEDIATELY UPON REMOVAL FROM THE PACKAGING. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23539573 ↗
• MalfunctionMar 13, 2025Device Damaged Prior to Use; Device Contamination with Chemical or Other Material; Device Damaged Prior to Use; Device Contamination with Chemical or Other Material

  INFORMATION WAS RECEIVED FROM A DISTRIBUTOR REGARDING A GENERATOR. IT WAS REPORTED THAT THE DUST PARTICLE FOUND IN STERILE PACKAGING. NO PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21591743 ↗
• MalfunctionApr 18, 2023No Device Output; No Device Output

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER REGARDING A HANDPIECE. IT WAS REPORTED THAT  WHEN PACKAGING WAS OPENED, THE ITEMS WERE BROKEN AND DID NOT WORK. THIS OCCURRED WITH TWO OF THE ITEMS.  THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16762784 ↗
• MalfunctionApr 18, 2023Break; No Device Output; Break; No Device Output

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER REGARDING A HANDPIECE. IT WAS REPORTED THAT  WHEN PACKAGING WAS OPENED, THE ITEMS WERE BROKEN AND DID NOT WORK. THIS OCCURRED WITH TWO OF THE ITEMS.  THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16762776 ↗
• MalfunctionOct 1, 2022Break; Failure to Power Up; Break; Failure to Power Up

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING TWO HANDPIECES. IT WAS REPORTED THAT THE SITE HAS TWO HANDPIECES THAT WOULD NOT POWER ON BECAUSE WHEN THE PROTECTIVE TAB WAS REMOVED, IT BROKE, PREVENTING PROPER CONTACT BETWEEN WITH THE BATTERY. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15525708 ↗
• MalfunctionOct 1, 2022Break; Failure to Power Up; Break; Failure to Power Up

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING TWO HANDPIECES. IT WAS REPORTED THAT THE SITE HAS TWO HANDPIECES THAT WOULD NOT POWER ON BECAUSE WHEN THE PROTECTIVE TAB WAS REMOVED, IT BROKE, PREVENTING PROPER CONTACT BETWEEN WITH THE BATTERY. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15524517 ↗
• MalfunctionNov 24, 2020Failure to Power Up

  MIDDLE-AGED FEMALE WITH HISTORY OF BREAST CANCER POSITIVE GENE MUTATION. HAVING SURGERY FOR BREAST RECONSTRUCTION AND IMPLANT, THE MEDTRONIC RADIALUX LIGHTED RETRACTOR WOULD NOT TURN ON. NO KNOWN HARM TO PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10894090 ↗

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