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-410-154, R-410-154
- 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
This device is a reprocessed laser atherectomy catheter used to treat infrainguinal stenoses and occlusions. Reprocessing entails cleaning and sterilizing used devices for reuse in clinical settings.
Why This Is Dangerous
A breach in sterile barrier packaging can allow contamination, potentially leading to infection during catheter use.
Industry Context
This recall is not described as part of a broader industry pattern.
Real-World Impact
Hospitals may need to halt procedures involving this catheter and coordinate replacements or alternative therapies. Reprocessing-related recalls can drive additional cost and workflow disruption.
Practical Guidance
How to identify if yours is affected
- Verify model number R-410-154 on the device and packaging
- Confirm lot numbers fall within shelf life with expiration before 29AUG2026
- Ensure the device was distributed for US use (not cleared for US marketing)
Where to find product info
Labeling on device and packaging; recall notification letter from the manufacturer
What timeline to expect
Recall is active as of 2025-08-29. Replacement or refund timelines vary; hospitals should expect coordinated notices by letter.
If the manufacturer is unresponsive
- Escalate to hospital administration
- Contact regulatory authorities if manufacturer response is slow
- Document all communications and store correspondence for records
How to prevent similar issues
- For future purchases, verify US clearance status before use
- Implement sterile barrier integrity checks during reprocessing
- Maintain updated recall contact lists for suppliers and hospitals
Documentation advice
Keep recall letters, model and lot numbers, UDI-DI, and all correspondence with the manufacturer and hospital records.
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Product Details
Model No: R-410-154 UDI-DI: 00850044399062 Sold to: US nationwide (CA, FL, IL, KS, LA, MD, MI, MO, NC, NJ, NM, NV, NY, PA, TN, TX, VA) Sold since: Unknown Price: Unknown
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Model No R-410-154
- Not cleared for US marketing
- All lot numbers within labeled shelf life with expiration prior to 29AUG2026
- Distribution: CA, FL, IL, KS, LA, MD, MI, MO, NC, NJ, NM, NV, NY, PA, TN, TX, VA
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Safety Guide
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