Quick Facts at a Glance
- Recall Date
- August 29, 2025
- Hazard Level
- HIGH
- Brand
- Northeast Scientific
- Category
- Health & Personal Care
- Sold At
- Unknown
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- Northeast Scientific
- Product type
- Laser Atherectomy Catheter
- Model numbers
- R-420-006
- Sold at
- Unknown
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
August 29, 2025
Reported by FDA DEVICE
October 8, 2025
RecallRadar source check
April 18, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
Potential for breaches in the sterile barrier packaging, compromising sterility assurance.
What You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Northeast Scientific Inc. or your healthcare provider for instructions. Notification method: Letter
About This Product
The device is a reprocessed 2.0mm OTW Turbo Elite Laser Atherectomy Catheter used to treat infrainguinal stenoses and occlusions.
Why This Is Dangerous
A breach in the sterile barrier packaging can compromise sterility, raising infection risk during procedures.
Industry Context
This recall is not described as part of a broader industry pattern.
Real-World Impact
Healthcare facilities must identify affected lots, halt use, and follow manufacturer instructions to safeguard patients.
Practical Guidance
How to identify if yours is affected
- Verify model R-420-006 on the device labeling.
- Confirm lot numbers and expiration dates prior to 29AUG2026.
- Ensure devices are not used or distributed further.
Where to find product info
Device labeling and the FDA recall page provide model and UDI details.
What timeline to expect
Immediate recall actions with manufacturer notification by letter; continue to monitor for updates.
If the manufacturer is unresponsive
- Document all contact attempts with the manufacturer.
- Escalate concerns to the FDA recall contact or medical device reporting channels if needed.
How to prevent similar issues
- Verify FDA clearance status before procuring reusable or reprocessed devices.
- Inspect sterile packaging before use and discard any breached packaging.
- Ask suppliers for current recall status and UDI information.
- Maintain an inventory log to isolate recalled lots quickly.
Documentation advice
Keep recall notice, capture device lot and serial numbers, save correspondence with the manufacturer and facilities, document any patient exposure.
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Product Details
Model No: R-420-006 UDI-DI: 00850044399079 Not cleared for US marketing Distribution: US nationwide to CA, FL, IL, KS, LA, MD, MI, MO, NC, NJ, NM, NV, NY, PA, TN, TX, VA Quantity: 199 units Sold since: Unknown Price: Unknown
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Model No R-420-006
- Not cleared for US marketing
- All lots within shelf life expiring before 29AUG2026
- Distributes nationwide across 17 states
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Safety Guide
Not sure what to do next? Our guide walks you through the process step by step.
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