Medtronic RadiaLux Lighted Retractor recalled for defective sterile pouch seal
Medtronic is recalling 2,317 RadiaLux Lighted Retractor units due to defects in the sterile pouch seal that increase contamination risk and potential post-operative infection.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall of a critical surgical instrument where the sterile barrier (pouch seal) is defective, creating a theoretical but serious risk of post-operative infection. No illnesses or injuries have been reported, placing it in the High category per the rubric: 'risk-of-harm products where injury has not yet been reported.'
Plain-English summary
Medtronic Navigation, Inc. is recalling the RadiaLux Lighted Retractor (Pink), REF 50-101-1, across the United States. The recall affects 2,317 units distributed nationwide.
The sterile pouch seal on the affected units is defective or incomplete. This defect increases the risk of contamination of the surgical instrument, which can lead to post-operative infection when the retractor is used in surgical procedures.
This recall affects medical facilities that received affected units, identified by lot codes 705F, 706F, 707F, 708F, and 709F. Healthcare facilities using these units should discontinue use of recalled retractors and contact Medtronic for instructions on replacement or return.
Patients or healthcare providers with questions about this recall should contact Medtronic Navigation, Inc. for additional information.
The recalled product
- Product
- RadiaLux Lighted Retractor (Pink), REF: 50-101-1
- Manufacturer
- Medtronic Navigation, Inc.
- Affected units
- 2,317
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (5)
- UDI-DI/Lot: 00763000432805/ 705F
- 706F
- 707F
- 708F
- 709F
Distribution
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