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-417-152, UDI-DI 00850044399093
- 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 device is a reprocessed laser atherectomy catheter used in vascular procedures to treat infrainguinal stenoses and occlusions. It is not cleared for US marketing and is distributed to healthcare facilities.
Why This Is Dangerous
Breach in sterile barrier packaging can compromise sterility, increasing infection risk during procedures.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Hospitals and clinics must halt use. Potential procedure delays and supply disruption may occur while awaiting guidance on safe alternatives.
Practical Guidance
How to identify if yours is affected
- Verify model number R-417-152
- Inspect shelf-life dates; all lots expiring before 29AUG2026 are affected
Where to find product info
UDI label and model number on the device packaging and documentation
What timeline to expect
Notification by letters; typical processing steps for recall vary by facility
If the manufacturer is unresponsive
- Escalate to hospital risk manager
- Contact regulatory authority if supplier unresponsive
- Document all communications
How to prevent similar issues
- Verify clearance status before procurement
- Prefer devices with clear FDA clearance and traceable lot numbers
- Maintain sterile-packaging integrity checks
Documentation advice
Keep recall letter, purchase records, serial numbers, and correspondences for audit and potential claims
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Product Details
Model No. R-417-152. UDI-DI 00850044399093. Quantity: 165 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 as of 2025-08-29.
Reported Incidents
No injuries or incidents have been reported in the provided documentation.
Key Facts
- Model No. R-417-152
- Not cleared for US marketing
- Sterile barrier breach risk
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Safety Guide
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