Quick Facts at a Glance
- Recall Date
- August 29, 2025
- Hazard Level
- HIGH
- Brand
- Northeast Scientific
- Category
- Health & Personal Care
- Sold At
- Multiple Retailers
- 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-420-159, UDI-DI 00850044399086
- Sold at
- Multiple Retailers
- 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 laser atherectomy catheter used in vascular procedures to treat infrainguinal stenoses and occlusions. Reprocessed devices are intended for reuse after cleaning and sterilization.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Hospitals and clinicians may need to replace the device and monitor patients for potential infections. The recall involves 141 units and may affect patient safety if used.
Practical Guidance
How to identify if yours is affected
- Verify model number R-420-159.
- Inspect lot numbers for shelf-life validity (expires before 29AUG2026).
Where to find product info
Recall details and identification numbers are in the FDA recall page and manufacturer letter.
What timeline to expect
Refunds or replacements, if offered, typically follow the manufacturer’s recall process communicated in the recall letter.
If the manufacturer is unresponsive
- Document all communications with the manufacturer and healthcare facility.
- Escalate to regulatory authorities if needed.
- Consult your institution's risk management team.
How to prevent similar issues
- Always verify UDI and model numbers before use.
- Ensure devices are sourced through authorized channels.
- Confirm shelf-life and packaging integrity prior to use.
Documentation advice
Keep the recall notice, packaging, serial numbers, UDI, and all correspondence with the manufacturer and healthcare providers.
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Product Details
Model No: R-420-159. UDI-DI: 00850044399086. All lot numbers within shelf life with expiration dates prior to 29AUG2026. Distribution: US nationwide to CA, FL, IL, KS, LA, MD, MI, MO, NC, NJ, NM, NV, NY, PA, TN, TX, VA. Not cleared for marketing in the US. Quantity: 141 units.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Shelf-life: expires before 29AUG2026
- Not cleared for US marketing
- Sterile barrier breach risk
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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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