Quick Facts at a Glance
- Recall Date
- August 29, 2025
- Hazard Level
- HIGH
- Brands
- Northeast Scientific, NES
- Category
- Health & Personal Care
- Sold At
- Unknown
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL, PREGNANT, PETS
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, NES
- Product type
- Atherectomy Catheter
- Model numbers
- R-414-159, UDI-DI 00850044399123
- Sizes
- 1.4mm
- 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
This reprocessed 1.4mm RX Turbo Elite Laser Atherectomy Catheter is used by interventional cardiologists and vascular surgeons in peripheral arterial interventions to remove plaque from infrainguinal vessels.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Hospitals must assess inventory, implement retesting of sterility, and consider alternative devices to avoid infection risks. Users face potential delays in procedures and patient safety concerns.
Practical Guidance
How to identify if yours is affected
- Check model number R-414-159.
- Check shelf life expiration dates prior to 29AUG2026.
Where to find product info
Find serial numbers and UDI on the device label and packaging.
What timeline to expect
Refund/replacement timelines not specified; coordinate with NES and hospital procurement.
If the manufacturer is unresponsive
- Escalate to regulatory authorities and document correspondence.
- Consult hospital compliance for recall response.
How to prevent similar issues
- Verify US clearance status before procurement.
- Routinely audit sterile barrier packaging integrity.
- Ensure suppliers provide clear recall notices before use.
Documentation advice
Document product lot numbers, procurement records, and patient exposure history.
Get instant alerts for Health & Personal Care recalls
Be the first to know. Free instant alerts to your inbox.
Product Details
Model No. R-414-159. UDI-DI 00850044399123. Quantity 1,019 units. Distribution: US nationwide to CA, FL, IL, KS, LA, MD, MI, MO, NC, NJ, NM, NV, NY, PA, TN, TX, VA. Status: ACTIVE. Recall Date: 2025-08-29. Report Date: 2025-10-08. Brand: Northeast Scientific (NES). Category: Medical Devices. Sold as reprocessed device not cleared for US marketing.
Reported Incidents
No specific incidents or injuries are mentioned in the recall notice.
Key Facts
- Model No R-414-159
- Shelf life expiration prior to 29AUG2026
- US nationwide distribution to 15 states
Browse More Recalls
Safety Guide
Not sure what to do next? Our guide walks you through the process step by step.
Read: What to Do When You Find a Recalled ProductGet Alerts for Health & Personal Care Recalls
Get instant alerts for recalls that affect you. Free forever.