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-414-151, UDI-DI 00850044399116
- 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 vascular device used to treat infrainguinal stenoses and occlusions. It is reprocessed and marketed in some regions but not cleared for US marketing.
Industry Context
This recall is not described as part of a broader industry pattern in the notice.
Real-World Impact
Hospitals and clinics may need to quarantine affected units and review sterile-packaging controls. The recall creates potential treatment delays for patients relying on this catheter.
Practical Guidance
How to identify if yours is affected
- Verify model number R-414-151 and UDI 00850044399116 on the device label or packaging.
- Check lot numbers against shelf-life criteria (within shelf life and expiration before 29AUG2026).
- Confirm that the device was distributed in the US and returned per recall instructions.
Where to find product info
Refer to the FDA recall page for Z-0019-2026 and the NES recall notification for instructions and remedies.
What timeline to expect
Not specified by the manufacturer.
If the manufacturer is unresponsive
- Escalate with hospital procurement and risk management.
- File a complaint with the FDA if the manufacturer does not respond in a timely manner.
How to prevent similar issues
- Verify sterile barrier integrity before use in any device reuse program.
- Ensure strict adherence to packaging standards for reprocessed devices.
- Coordinate with suppliers to ensure recalled lots are removed from inventory.
Documentation advice
Keep recall notices, purchase records, packaging images, and all correspondence with the manufacturer for audit and potential claims.
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Product Details
Model No: R-414-151 UDI-DI: 00850044399116 Sold: US nationwide distribution to CA, FL, IL, KS, LA, MD, MI, MO, NC, NJ, NM, NV, NY, PA, TN, TX, VA Sold since: Not cleared for US marketing Quantity: 173 units Shelf-life: Expiration dates prior to 29AUG2026 Price: Unknown
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Not cleared for US marketing
- Shelf life through 29AUG2026
- US nationwide distribution to listed states
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