Class II U.S. Food and Drug Administration

Northeast Scientific Inc. NES Reprocessed 1.7mm OTW 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

The concern here is contamination of a product that bypasses the body’s normal defences, which is why the threshold for recalling it is low.

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-0020-2026
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
165 units
Distribution
Nationwide
Made in
United States
Lot / code info
Model No R-417-152; UDI-DI 00850044399093; All Lot Numbers that are within their labeled shelf life with expiration dates prior to 29AUG2026
UPC codes
00850044399093

Products covered by this recall

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.

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.

  • 00850044399093

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. — The concern here is contamination of a product that bypasses the body’s normal defences, which is why the threshold for recalling it is low.

  1. Stop using the affected lot and check the lot number on your own carton or vial against the codes listed above.
  2. If you are a clinic or pharmacy, quarantine the stock and work it through your usual recall log.
  3. Report any infection or reaction you think the product caused to FDA MedWatch.
  4. Do not use a vial or syringe with visible particles, cloudiness or discolouration, whether or not it is on the recall list.

Getting a replacement supply

Do not let a refund question interrupt your treatment. Deal with the supply first and the money second.

  • Call the pharmacy before you run low. They can see which lot they dispensed to you and will usually swap it the same day.
  • Insurers do not normally count a recall replacement against a refill limit. If one is refused, ask the pharmacist to call it through as a recall override.
  • Over-the-counter products are refunded at the till like any other purchase; the recall notice on your phone is enough to explain the return.
  • If the manufacturer runs a direct reimbursement form, it will be linked from the official notice on this page.

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 00850044399093. 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?

Call the pharmacy before you run low. They can see which lot they dispensed to you and will usually swap it the same day.

Where was the recalled product sold?

It was distributed nationwide.

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