FDA Device recall Z-0953-2023
RadiaLux Lighted Retractor (Pink), REF: 50-101-1
- FDA Device
- Class II
- ongoing
- Published 2023-01-18
On 2023-01-18 the FDA classified a Class II recall of RadiaLux Lighted Retractor (Pink), REF: 50-101-1 by Medtronic Navigation, citing defect in sterile pouch seal, incomplete seal, of lighted Retractors, increases the risk of contamination, which can lead to post-operative infection.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0953-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-12-08 |
| Published | 2023-01-18 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Medtronic Navigation |
| Distribution | US |
Product
RadiaLux Lighted Retractor (Pink), REF: 50-101-1
Reason
Defect in sterile pouch seal, incomplete seal, of lighted Retractors, increases the risk of contamination, which can lead to post-operative infection.
Identifiers
| code_info | UDI-DI/Lot: 00763000432805/ 705F, 706F, 707F, 708F, 709F |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0953-2023%22
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