Class II U.S. Food and Drug Administration

Northeast Scientific Inc. NES Reprocessed 2.0mm RX Turbo Elite Laser Atherectomy recall: Potential for breaches in the sterile barrier packaging

Recall published 1+ years ago

Potential for breaches in the sterile barrier packaging, compromising sterility assurance.

The hazard: Sterility or particulate concern

Particulate matter or a sterility failure prompted this notice, the most common reason injectable and ophthalmic products are withdrawn.

What the notice says: Potential for breaches in the sterile barrier packaging, compromising sterility assurance.

Why it matters: The product was made or packaged in conditions that cannot assure sterility, or visible particles were found in it. For anything injected, infused or used in the eye, that is a direct route for contamination into the body.

Symptoms and when to call a doctor

Watch for fever, chills, pain, redness, swelling or discharge at an injection site, and for a red, painful or suddenly blurred eye after using an eye product. Any of these needs same-day medical attention. Do not wait to see whether it settles, and tell the clinician which product and lot you used so it can be reported against the recall.

This page is general information, not medical advice. If you feel unwell, a clinician who can see you is the only person able to judge your case.

Recall details

Recall number
Z-0025-2026
Published
October 8, 2025
Risk level
Class II
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
Northeast Scientific Inc.
Product type
Medical devices
Units affected
141 units
Distribution
Nationwide
Made in
United States
Lot / code info
Model No R-420-159; UDI-DI 00850044399086; All Lot Numbers that are within their labeled shelf life with expiration dates prior to 29AUG2026.
UPC codes
00850044399086

Products covered by this recall

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.

Check your product

The notice names 1 code you can read straight off the package. Type the one printed on yours and the list below narrows to it.

UPC / barcode

Read the twelve digits under the barcode on the package.

  • 00850044399086

Codes are lifted verbatim from the FDA — Device enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Sterility

Northeast Scientific Inc. — Particulate matter or a sterility failure prompted this notice, the most common reason injectable and ophthalmic products are withdrawn.

  1. Stop using the affected lot and check the lot number on your own carton or vial against the codes listed above.
  2. Do not use a vial or syringe with visible particles, cloudiness or discolouration, whether or not it is on the recall list.
  3. Call your prescriber or pharmacy today about a replacement from an unaffected lot — do not simply skip doses of a medicine you depend on.
  4. If you are a clinic or pharmacy, quarantine the stock and work it through your usual recall log.

What the company owes you

A recalled medicine is the manufacturer’s cost to carry, not yours or your pharmacist’s.

  • The purchase price or co-pay is refundable, and so is the cost of returning the product if they ask you to ship it.
  • Ask the pharmacy to handle the claim where they can — they process recall returns in bulk and it saves you the correspondence.
  • Keep the carton, the leaflet and the pharmacy label together until the claim is closed.
  • Costs beyond the price of the medicine need to go to the company directly, in writing, with the recall number quoted.

Company contact: Northeast Scientific Inc. — 2142 Thomaston Ave, Waterbury, CT, 06704-1013

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Device enforcement record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Northeast Scientific Inc. medical devices recalled?

Potential for breaches in the sterile barrier packaging, compromising sterility assurance. Potential for breaches in the sterile barrier packaging, compromising sterility assurance.

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: UPC 00850044399086. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Stop using the affected lot and check the lot number on your own carton or vial against the codes listed above.

Can I get my money back?

The purchase price or co-pay is refundable, and so is the cost of returning the product if they ask you to ship it.

Where was the recalled product sold?

It was distributed nationwide.

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