RadiaLux recallZ-0953-2023 · Medtronic Navigation, Inc. · initiated Dec 8, 2022
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Medtronic Navigation, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Defect in sterile pouch seal, incomplete seal, of lighted Retractors, increases the risk of contamination, which can lead to post-operative infection.
FDA root cause category: Equipment maintenance
What the company is doing
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]
Recall details
- Recall number
- Z-0953-2023
- Status
- Open, Classified
- Initiated by the company
- Dec 8, 2022
- Posted by the FDA
- Jan 12, 2023
- Recalling firm
- Medtronic Navigation, Inc.
- Quantity
- 2317
- Product code
- GAD
- 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.
Product description
RadiaLux Lighted Retractor (Pink), REF: 50-101-1
Code information (models, lots, serial numbers)
UDI-DI/Lot: 00763000432805/ 705F, 706F, 707F, 708F, 709F
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- RadiaLux™ 50-101-1Medtronic Navigation, Inc. · RETRACTOR1 recall2 reports
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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