Reported Oct 8, 2025 · Ongoing
NES Reprocessed 0.9mm OTW Turbo Elite Laser Atherectomy Catheter. Model Number: R-410-152. The NES Reprocessed…
Northeast Scientific Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Northeast Scientific Inc. · 2142 Thomaston Ave · Waterbury, CT · 06704-1013
Is this the product you have?
- NES Reprocessed 0.9mm OTW Turbo Elite Laser Atherectomy Catheter
- Model NumberR-410-152. The NES Reprocessed Turbo-Elite Laser Atherectomy Catheter is indicated for use in the treatment, including atherectomy, of infrainguinal stenoses and occlusions
- Lot codes and dates
- Model No R-410-152; UDI-DI 00850044399055; All Lot Numbers that are within their labeled shelf life with expiration dates prior to 29AUG2026
- Amount recalled
- 561 units
This recall covers 8 products
The agency filed one notice per product. You are reading one of them; the other 7 are below.
Where it was sold
Why it was recalled
Potential for breaches in the sterile barrier packaging, compromising sterility assurance.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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