Northeast Scientific NES Reprocessed 1.7mm RX Turbo Elite Laser Atherectomy Catheter recall — FDA Z-0024-2026
Potential for breaches in the sterile barrier packaging, compromising sterility assurance.
Overview of recall records associated with Northeast Scientific Inc., including dates, categories and classifications where available.
Classification mix: Class II: 9.
Potential for breaches in the sterile barrier packaging, compromising sterility assurance.
Potential for breaches in the sterile barrier packaging, compromising sterility assurance.
Potential for breaches in the sterile barrier packaging, compromising sterility assurance.
Potential for breaches in the sterile barrier packaging, compromising sterility assurance.
Potential for breaches in the sterile barrier packaging, compromising sterility assurance.
Potential for breaches in the sterile barrier packaging, compromising sterility assurance.
Potential for breaches in the sterile barrier packaging, compromising sterility assurance.
Potential for breaches in the sterile barrier packaging, compromising sterility assurance.
510k indicated one (1) reprocessing cycle, product not cleared for additional reprocessing cycles.
This page summarizes recall records in which the official source identifies Northeast Scientific Inc. as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.