Z-0953-2023Class II

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

Name: Z-0953-2023 RadiaLux Lighted Retractor (Pink), REF: 50-101-1
Creator: Medtronic Navigation, Inc.
Published: 2022-12-08
License: https://open.fda.gov/license/

Medtronic Navigation, Inc / initiated 2022-12-08 / Open, Classified / root cause: manufacturing process

FDA source

Medtronic Navigation, Inc. began a recall of RadiaLux Lighted Retractor (Pink), REF: 50-101-1 on 2022-12-08. FDA classified it as Class II and gives the reason as "Defect in sterile pouch seal, incomplete seal, of lighted Retractors, increases the risk of contamination, which can lead to post-operative infection". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0953-2023
Classification: Class II
Status: Open, Classified
Initiated: 2022-12-08
Posted: 2023-01-12
Recalling firm: Medtronic Navigation, Inc
Product: RadiaLux Lighted Retractor (Pink), REF: 50-101-1
Product code: GAD Retractor
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.
Root cause tag: manufacturing process
FDA root cause: Equipment maintenance
Action: On 11/17/22 customers were verbally notified to quarantine affected devices. On 12/08/22, recall notices were sent to customers asking them to take the following action: 1) Discontinue use of affected devices. 2) Return affected devices to the recalling firm. 3) Complete and return the customer confirmation form that can be emailed to [email protected] 3) The notice needs to be shared with all who need to be aware within your organization and any organization where the potentially affected devices have been transferred. Customers with questions are encouraged to call/email: Medtronic Technical Services at 1-888-826-5603/[email protected]
Quantity in commerce: 2317
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.
Product codes and lots: UDI-DI/Lot: 00763000432805/ 705F, 706F, 707F, 708F, 709F

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0953-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0953-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-01-18	2023-01-12

Product code GAD

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)