Medtronic Navigation, Inc. recalls RadiaLux Lighted Retractor (Pink), REF: 50-101-1
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 notice →- Date
- 2023-01-18
- Country
- United States
- Brand
- Medtronic Navigation
- Product
- RadiaLux Lighted Retractor (Pink), REF: 50-101-1
- Classification
- Class II
- Units
- US Nationwide distribution including in the states of OH, CA, FL, NJ, NY, MN,…
- Category
- Drugs & medical
- Source
- FDA · Device
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
What to do
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- Ask the pharmacy or supplier about a replacement or refund.
General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
More Medtronic Navigation recalls
- 2023-06-14
USMedtronic Navigation, Inc. recalls StealthStation Cranial Software, Model: 9735585, used with StealthStation S7/i7 systems
In nonaxial/some axial exams if surgical plan utilized, Target Guidance selected, tip projection utilized, Navigate Projection enabled, software anomaly may occur during tumor resection/shunt placement/deep brain…
FDA · DeviceMedtronic Navigation, Inc.US Distribution: PR. OUS (foreign) distribution: ARGENTINA, AUSTRALIA,…Official notice →- US
Medtronic Navigation, Inc. recalls StealthStation Cranial Software, Models: 9735585, 9735586 (kit), 9735587 (kit), used with StealthStation S7/i7 systems
During non-axial/some axial exams, software anomalies occur during procedures affecting depth gauge graphic displays for cranial biopsy; causing displays to no longer synchronize with other navigational information…
FDA · DeviceMedtronic Navigation, Inc.Worldwide Distibution: US (nationwide): OH, IL, CA, MI, FL, LA, OK, WA, AR,…Official notice → - 2023-02-08
- US
Medtronic Navigation, Inc. recalls AxiEM" Non-Invasive Patient Tracker
Due to increasing complaint trend for the Non-Invasive Patient Tracker system where complaints analysis indicates that users are unable to successfully verify their navigation instruments during image-guided surgery.
FDA · DeviceMedtronic Navigation, Inc.Worldwide - U.S. distribution including in the states of AL, AR, AZ, CA, CO,…Official notice → - 2022-11-23
- US
Medtronic Navigation, Inc. recalls Visualase Cooled Laser Applicator System (VCLAS) 9735560 .4MM CORE FIBER 10MM TIP product. Used to necrotize or coagulate soft tissue…
Due to a defect in the outer pouch sterile seal
FDA · DeviceMedtronic Navigation, Inc.U.S. Nationwide distribution including in the states AZ, CA, CO, DC, FL, IL,…Official notice → - 2021-12-29
- US
Medtronic Navigation, Inc. recalls Stealth Autoguide Tracker, Model: 28248, which is an instrument in the Stealth Autoguide Basic Instrument Kit, Mode: 9736188, and the…
A tracker that holds and guides neurosurgical surgical instruments may be subject to separation/weld failure, where the tracker connects to the instrument tube. If a weld separation occurs and a navigation inaccuracy…
FDA · DeviceMedtronic Navigation, Inc.US: FL, NE, CA, MN, TX, OH, IL, AZ, KS, KY, OR, OK, WA, NV, MO, IN, MI, UT,…Official notice → - US
Medtronic Navigation, Inc. recalls Stealthstation System w/ Stealthstation Cranial Software 3.1.1,3.1.2,3.1. or SynergyCranial Software. Synergy Cranial, Model:…
Cranial biopsy procedure software can enter a state where the biopsy depth gauge is no longer synchronized with the rest of the navigational information on the screen and may display an incorrect position of the biopsy…
FDA · DeviceMedtronic Navigation, Inc.US: MN, FL, MD, IL, AK, NE, NH, PA, ND, AR, CA, WI, NJ, GA, SD, AZ, KY, AL,…Official notice →
Other drugs & medical recalls in the United States
- 2023-01-25
- US
Fresenius Kabi USA, LLC recalls Sensorcaine (Bupivacaine HCl and Epinephrine Injection, USP) with Epinephrine 1:200,000 (as bitartrate), 0.5%, 250 mg per 50 mL (5 mg per…
Subpotent Drug: Testing results below the defined limit for the epinephrine portion of this product.
- 2023-01-18
- US
Covidien, LLC recalls COVIDIEN Emprint Ablation Catheter with Thermosphere Technology, Bronchoscopic Ablation, REF CA108L1
The product is labeled with the incorrect expiration date.
- US
CoreLink LLC recalls CoreLink LLC, FLXFIT 15, 32MM X 8MM, CAGE, REF: AT3208
Specific lots of FLXfit implants have internal components that may have been manufactured using stainless steel rather than the specified titanium alloy.
- US
Roche Diagnostics Operations, Inc. recalls cobas infinity central lab, Material Number 07154003001
A complaint investigation revealed that an incorrect behavior relating to the rejection of orders capability of the Host Connectivity Agent (HCA) could occur where the order received from the Laboratory Information…
FDA · DeviceRoche Diagnostics Operations, Inc.Domestic distribution nationwide. Foreign distribution pending.Official notice → - US
Depuy Ireland UC recalls BIOSTOP G BIORESORBABLE CEMENT RESTRICTOR Catalog Numbers: 546308000 (Size 8); 546310000 (Size 10); 546312000 (Size 12); 546314000 (Size…
All lots of BIOSTOP G Bioresorbable Cement Restrictor are being removed as a precautionary measure because tested endotoxin levels were higher than recommended by the current FDA regulatory guidance. In general,…
FDA · DeviceDepuy Ireland UCWorldwide distribution - US Nationwide and the countries of Argentina,…Official notice → - US
Siemens Healthcare Diagnostics, Inc. recalls IMMULITE 2000 Thyroglobulin (US)- For in vitro diagnostic use with the IMMULITE 2000 Systems Analyzers (IMMULITE 2000/…
Potential for Functional Sensitivity to not meet Instructions For Use (IFU) claims with the kit lots; control level one may result outside of published ranges; when control results are in range, users may observe…
FDA · DeviceSiemens Healthcare Diagnostics, Inc.Nationwide Foreign: Argentina¿¿¿¿¿¿ Australia¿¿¿¿¿¿ Austria¿¿¿¿¿¿¿¿…Official notice →