# FDA recall Z-0953-2023

> **Medtronic Navigation, Inc.** · Class II · device recall initiated 2022-12-08.

## Product

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

## 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.

## 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.

## Key facts

- **Recall number:** Z-0953-2023
- **Recalling firm:** Medtronic Navigation, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-12-08
- **Report date:** 2023-01-18

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Louisville, CO, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0953-2023

## Citation

> AI Analytics. FDA recall Z-0953-2023. Retrieved 2026-07-16 from https://api.ai-analytics.org/recall/Z-0953-2023. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*