Quick Facts at a Glance
- Recall Date
- August 29, 2025
- Hazard Level
- HIGH
- Brands
- Northeast Scientific, NES Reprocessed
- 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 Reprocessed
- Product type
- Laser Atherectomy Catheter
- Model numbers
- R-410-152, UDI-DI 00850044399055
- Sizes
- 0.9mm
- 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
Laser atherectomy catheters are used in endovascular procedures to treat infrainguinal stenoses and occlusions. Reprocessing of devices involves cleaning and re-sterilization for reuse in healthcare settings.
Why This Is Dangerous
A breached sterile barrier can lead to contamination and infection risk for patients undergoing procedures with the catheter.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
The recall focuses on sterility risk rather than immediate device malfunction. Affected facilities must implement recall procedures and monitor for potential post-procedure infections.
Practical Guidance
How to identify if yours is affected
- Check Model R-410-152.
- Confirm shelf life date not past 29AUG2026.
Where to find product info
Model numbers and UDI codes are on device packaging and labeling.
What timeline to expect
Recall processing and refunds/replacements may take several weeks.
If the manufacturer is unresponsive
- Document all communications with the vendor.
- Escalate to hospital risk management or regulatory bodies if the vendor is unresponsive.
How to prevent similar issues
- Ensure sterile barrier integrity during packaging and re-sterilization processes.
- Follow manufacturer reprocessing guidelines.
- Verify packaging before use in any endovascular procedure.
Documentation advice
Keep recall letter, packaging, lot numbers, and any healthcare facility communications; photograph packaging seals and labels.
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Product Details
Model No R-410-152. UDI-DI 00850044399055. Distribution: US nationwide to CA, FL, IL, KS, LA, MD, MI, MO, NC, NJ, NM, NV, NY, PA, TN, TX, VA. Quantity: 561 units. Sold/used in medical settings prior to recall date 2025-08-29.
Reported Incidents
No specific injuries or incidents were reported in the recall notice.
Key Facts
- Model No R-410-152
- Shelf life through 29AUG2026
- US nationwide distribution to listed states
- Sterile barrier breach could compromise sterility
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Safety Guide
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