RadiaLux Lighted Retractor — Class II medical device recall Z-0953-2023
Ongoing recall by Medtronic Navigation, Inc., reported 2023-01-18, distributed nationwide. Defect in sterile pouch seal, incomplete seal, of lighted Retractors, increases the risk of contamination, whi
| Recall number | Z-0953-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medtronic Navigation, Inc., Louisville, CO, United States |
| Recall initiated | 2022-12-08 |
| Classified | 2023-01-12 |
| Reported by FDA | 2023-01-18 |
| Distributed | Nationwide (US) |
| Quantity | 2,317 |
| Reason classes | sterility, packaging |
| UPC / GTIN / UDI-DI | 00763000432805 |
| Lot numbers | 705F, 706F, 707F, 708F, 709F |
| Model numbers | 50-101-1 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0953-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.