Quick Facts at a Glance
- Recall Date
- August 29, 2025
- Hazard Level
- HIGH
- Brands
- Northeast Scientific, NES
- Category
- Health & Personal Care
- Sold At
- Multiple Retailers
- 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
- Laser Atherectomy Catheter
- Model numbers
- R-417-156, UDI-DI 00850044399109
- 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 NES Reprocessed Turbo-Elite Laser Atherectomy Catheter is a medical device used in endovascular treatment, including atherectomy, of infrainguinal stenoses and occlusions. It is not cleared for US marketing.
Why This Is Dangerous
A breach in sterile barrier packaging could compromise sterility assurance and pose infection risk to patients.
Industry Context
This recall is not clearly part of a broader industry pattern in the provided data.
Real-World Impact
Direct impact on patient safety and hospital workflow; immediate device discontinuation required and potential investigation for affected procedures.
Practical Guidance
How to identify if yours is affected
- Verify model number R-417-156 on the device and UDI-DI 00850044399109
- Check shelf-life expiration dates prior to 29AUG2026
- Confirm US distribution status with the hospital’s procurement records
Where to find product info
FDA recall page Z-0024-2026 and manufacturer communications
What timeline to expect
Refunds or replacements are not specified; follow manufacturer guidance and FDA updates
If the manufacturer is unresponsive
- Escalate to hospital compliance department
- Contact FDA recall coordinator if manufacturer is slow to respond
How to prevent similar issues
- Ensure devices are US-cleared before marketing or use
- Verify sterile packaging integrity prior to use
- Implement strict receiving QC to detect packaging breaches
- Maintain documentation of lot numbers and expiration dates
- Consider non-reprocessed device options for high-risk procedures
Documentation advice
Document model, lot, UDI, lot expiration, and communications with manufacturer; retain packaging and labeling for records
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Product Details
Model: R-417-156. UDI-DI: 00850044399109. Quantity: 616 units. Distribution: US nationwide to CA, FL, IL, KS, LA, MD, MI, MO, NC, NJ, NM, NV, NY, PA, TN, TX, VA. Sold/used by Northeast Scientific Inc. as reprocessed devices. Not cleared for marketing in the US.
Reported Incidents
No specific patient injuries or incidents are referenced in the provided recall notice.
Key Facts
- Shelf life expiration prior to 29AUG2026
- Not cleared for US marketing
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Safety Guide
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