Northeast Scientific recalls NES Reprocessed 1.4mm RX Turbo Elite Laser Atherectomy Catheter (Model R-414-159) due to potential sterile packaging breaches. Affected units sold with expiration dates before August 29, 2:06 PM, 2026.
Potential for breaches in the sterile barrier packaging, compromising sterility assurance.
Northeast Scientific is recalling a specific type of laser catheter that was reprocessed. The recall is because the sterile packaging might not stay sealed properly, which could lead to contamination during medical procedures.
The sterile packaging could become breached, meaning the catheter might not be sterile when used. This could lead to infections or other complications during medical procedures if the catheter is not properly sterilized.
Healthcare professionals using this catheter for medical procedures are likely affected. Patients receiving the catheter during procedures are at risk if the sterile packaging is compromised.
Check for the model number R-414-159 on the packaging. The catheter was sold with expiration dates before August 29, 2026.
Look for the model number R-414-159 and expiration date before August 29, 2026.
The recall indicates a potential risk to sterility, but the catheter is not cleared for marketing in the US. Healthcare professionals should follow the recall instructions.
Check the model number and expiration date. If it matches the recall criteria, contact Northeast Scientific for further instructions.
The recall focuses on potential sterility issues, not direct injury risks. The danger level is low_risk.
We’ve drafted a message you can send Northeast Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-0023-2026 — Northeast Scientific Northeast Scientific Hello, I own a Northeast Scientific that is covered by recall Z-0023-2026 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
