Northeast Scientific recalls NES Reprocessed 0.9mm OTW Turbo Elite Laser Atherectomy Catheter (Model R-410-152) due to potential sterile packaging breaches. Affected units have expiration dates before August 29, 2:2026.
Potential for breaches in the sterile barrier packaging, compromising sterility assurance.
Northeast Scientific is recalling a specific type of laser catheter that may have compromised sterile packaging, risking infection during medical procedures. This recall affects medical devices used to treat leg blockages.
The sterile packaging may have been breached during reprocessing, which could lead to contamination. This poses a risk of infection during medical procedures if the device is used without proper sterility.
Healthcare professionals using the NES Reprocessed 0.9mm OTW Turbo Elite Laser Atherectomy Catheter (Model R-410-152) for leg treatments. Patients receiving this device are at risk of infection if the sterile packaging is breached.
Check for the model number R-410-152 on the catheter. The device has an expiration date before August 29, 2026. This recall applies to all units within their labeled shelf life.
Verify the expiration date is before August 29, 2026.
Reach out to Northeast Scientific for further guidance on handling the device.
The recall indicates potential packaging breaches that could compromise sterility, so it is not recommended for use until the manufacturer confirms it is safe.
Check the expiration date and contact Northeast Scientific for instructions on handling the device.
Look for the model number R-410-152 and an expiration date before August 29, 2026.
We’ve drafted a message you can send Northeast Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-0018-2026 — Northeast Scientific Northeast Scientific Hello, I own a Northeast Scientific that is covered by recall Z-0018-2026 from Northeast Scientific. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
