CLASS II ONGOING Device recall · Reported 18 Jan 2023 · FDA Enforcement Report
RadiaLux Lighted Retractor (Pink) recalled by Medtronic Navigation
Medtronic Navigation is recalling RadiaLux Lighted Retractor (Pink), distributed nationwide in the US. The recall was initiated on 8 Dec 2022 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0953-2023
- FDA event ID
- 91328
- Recalling firm
- Medtronic Navigation, Louisville, CO
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 8 Dec 2022
- FDA classified
- 12 Jan 2023
- Reported
- 18 Jan 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Surgical Instruments
Timeline
| 8 Dec 2022 | Recall initiated by company | |
| 12 Jan 2023 | Classified by FDA | +35 days |
| 18 Jan 2023 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
RadiaLux Lighted Retractor (Pink), REF: 50-101-1
Where it was distributed
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.
Nationwide AlabamaArizonaCaliforniaColoradoConnecticutDelawareFloridaGeorgiaIllinoisIndianaKansasLouisianaMassachusettsMarylandMaineMichiganMinnesotaMissouriMississippiMontana
Questions about this recall
Why was it recalled?
Defect in sterile pouch seal, incomplete seal, of lighted Retractors, increases the risk of contamination, which can lead to post-operative infection.
Which lots are affected?
UDI-DI/Lot: 00763000432805/ 705F, 706F, 707F, 708F, 709F
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Medtronic Navigation
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|---|---|---|---|---|---|
| Device | CLASS II | Medtronic NDI Passive Spheres recalled by Medtronic Navigation | Medtronic Navigation | Sterility | 44 states |
| Device | CLASS II | Medtronic NDI Passive Spheres recalled by Medtronic Navigation | Medtronic Navigation | Sterility | 44 states |
| Device | CLASS II | Medtronic NDI Passive Spheres recalled by Medtronic Navigation | Medtronic Navigation | Sterility | 44 states |
| Device | CLASS II | Medtronic Biopsy Needle Kit recalled by Medtronic Navigation | Medtronic Navigation | Sterility | 44 states |
| Device | CLASS II | Medtronic Pin Sterile Percutaneous recalled by Medtronic Navigation | Medtronic Navigation | Other | Nationwide |
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All 3,905| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Pentax Medical Ultrasound Endoscope recalled by Pentax of America | Pentax of America | Sterility | Nationwide |
| Device | CLASS II | Pentax Medical Ultrasound Endoscope recalled by Pentax of America | Pentax of America | Sterility | Nationwide |
| Device | CLASS II | Pentax Medical Ultrasound Endoscope recalled by Pentax of America | Pentax of America | Sterility | Nationwide |
| Device | CLASS II | Pentax Medical Ultrasound Endoscope recalled by Pentax of America | Pentax of America | Sterility | Nationwide |
| Device | CLASS II | Ethilon Nylon Suture recalled by Ethicon | Ethicon | Device Malfunction | CA |