Northeast Scientific NES Reprocessed Laser Catheter Recall: Sterile Packaging Risk
Northeast Scientific recalls NES Reprocessed 1.7mm RX Turbo Elite Laser Atherectomy Catheter (Model R-417-156) due to potential sterile packaging breaches. Affected units sold with expiration dates before August 29, 2026.
Lower-risk recall
Potential for breaches in the sterile barrier packaging, compromising sterility assurance.
Contact the company
What happened, in plain English
Northeast Scientific is recalling its reprocessed laser atherectomy catheter (Model R-417-156) because the sterile packaging might be compromised. This could lead to infections during medical procedures if the device is used without proper sterility. Read more at govinfonow.com/recall/51496-northeast-scientific-nes-reprocessed-laser-catheter-recall-sterile-packaging-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/51496-northeast-scientific-nes-reprocessed-laser-catheter-recall-sterile-packaging-risk · Updated August 17, 2026 · FDA enforcement record: FDA #Z-0024-2026
Cite this page
“Northeast Scientific NES Reprocessed Laser Catheter Recall: Sterile Packaging Risk.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/51496-northeast-scientific-nes-reprocessed-laser-catheter-recall-sterile-packaging-risk. Based on FDA recall #Z-0024-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0024-2026%22&limit=1).
Why it’s dangerous
The sterile packaging may have breaches that compromise the device's sterility. If the packaging is not intact, the catheter could cause infections during medical procedures.
Who’s affected
Healthcare professionals using this catheter for vascular procedures are most at risk. Patients receiving the device during procedures could face infection if the sterile packaging is breached.
How to tell if you have this one
Check for the model number R-417-156 on the packaging. The device was sold with expiration dates before August 29, 2026.
- Brand
Northeast Scientific- Category
Medical device
All 8 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Ongoing- Distribution
US Nationwide distribution to CA, FL, IL, KS, LA, MD, MI, MO, NC, NJ, NM, NV, NY, PA, TN, TX, VA.
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| Z-0018-2026 | NES Reprocessed 0.9mm OTW Turbo Elite Laser Atherectomy Catheter. Model Number: R-410-152. The NES Reprocessed Turbo-Elite Laser Atherectomy Catheter is indicated for use in the treatment, including atherectomy, of infrainguinal stenoses and occlusions.; Model No R-410-152; UDI-DI 00850044399055; All Lot Numbers that are within their labeled shelf life with expiration dates prior to 29AUG2026 | 561 units |
| Z-0019-2026 | NES Reprocessed 1.4mm OTW Turbo Elite Laser Atherectomy Catheter. Model Number: R-414-151. The NES Reprocessed Turbo-Elite Laser Atherectomy Catheter is indicated for use in the treatment, including atherectomy, of infrainguinal stenoses and occlusions. This model is not cleared for marketing in the US.; Model No R-414-151; UDI-DI 00850044399116; All Lot Numbers that are within their labeled shelf life with expiration dates prior to 29AUG2026 | 173 units |
| Z-0020-2026 | NES Reprocessed 1.7mm OTW Turbo Elite Laser Atherectomy Catheter. Model Number: R-417-152. The NES Reprocessed Turbo-Elite Laser Atherectomy Catheter is indicated for use in the treatment, including atherectomy, of infrainguinal stenoses and occlusions. This model is not cleared for marketing in the US.; Model No R-417-152; UDI-DI 00850044399093; All Lot Numbers that are within their labeled shelf life with expiration dates prior to 29AUG2026 | 165 units |
| Z-0021-2026 | NES Reprocessed 2.0mm OTW Turbo Elite Laser Atherectomy Catheter. Model Number: R-420-006. The NES Reprocessed Turbo-Elite Laser Atherectomy Catheter is indicated for use in the treatment, including atherectomy, of infrainguinal stenoses and occlusions. This model is not cleared for marketing in the US.; Model No R-420-006; UDI-DI 00850044399079; All Lot Numbers that are within their labeled shelf life with expiration dates prior to 29AUG2026. | 199 units |
| Z-0022-2026 | NES Reprocessed 0.9mm RX Turbo Elite Laser Atherectomy Catheter. Model/Catalog Number: R-410-154. The NES Reprocessed Turbo-Elite Laser Atherectomy Catheter is indicated for use in the treatment, including atherectomy, of infrainguinal stenoses and occlusions. This model is not cleared for marketing in the US.; Model No R-410-154; UDI-DI 00850044399062; All Lot Numbers that are within their labeled shelf life with expiration dates prior to 29AUG2026. | 795 units |
| Z-0023-2026 | NES Reprocessed 1.4mm RX Turbo Elite Laser Atherectomy Catheter. Model Number: R-414-159. The NES Reprocessed Turbo-Elite Laser Atherectomy Catheter is indicated for use in the treatment, including atherectomy, of infrainguinal stenoses and occlusions. This model is not cleared for marketing in the US.; Model No R-414-159; UDI-DI 00850044399123; All Lot Numbers that are within their labeled shelf life with expiration dates prior to 29AUG2026. | 1,019 units |
| Z-0024-2026 | NES Reprocessed 1.7mm RX Turbo Elite Laser Atherectomy Catheter. Model Number: R-417-156. The NES Reprocessed Turbo-Elite Laser Atherectomy Catheter is indicated for use in the treatment, including atherectomy, of infrainguinal stenoses and occlusions. This model is not cleared for marketing in the US.; Model No R-417-156; UDI-DI 00850044399109; All Lot Numbers that are within their labeled shelf life with expiration dates prior to 29AUG2026. | 616 units |
| Z-0025-2026 | NES Reprocessed 2.0mm RX Turbo Elite Laser Atherectomy Catheter. Model Number: R-420-159. The NES Reprocessed Turbo-Elite Laser Atherectomy Catheter is indicated for use in the treatment, including atherectomy, of infrainguinal stenoses and occlusions. This model is not cleared for marketing in the US.; Model No R-420-159; UDI-DI 00850044399086; All Lot Numbers that are within their labeled shelf life with expiration dates prior to 29AUG2026. | 141 units |
What to do — step by step
Check Packaging Integrity
Inspect the sterile packaging for any signs of damage or breaches.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 17 states.
FDA distribution: “US Nationwide distribution to CA, FL, IL, KS, LA, MD, MI, MO, NC, NJ, NM, NV, NY, PA, TN, TX, VA.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: California, Florida, Illinois, Kansas, Louisiana, Maryland, Michigan, Missouri, Nevada, New Jersey, New Mexico, New York, North Carolina, Pennsylvania, Tennessee, Texas, Virginia.
Recall timeline
FDA published this recall 40 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-0024-2026 (August 29, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0024-2026 to see it in context.
- Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.