Recall Z-0018-2026— Northeast Scientific Inc.
Class II · Ongoing
Class II FDA medical device recall by Northeast Scientific Inc., initiated 2025-08-29. It names one FDA 510(k) clearance: K220171. Product: NES Reprocessed 0.9mm OTW Turbo Elite Laser Atherectomy Catheter. Model Number: R-410-152. The NES Reprocessed Turbo-Elite Laser Atherectomy Catheter is indicated for use in the treatment, including atherectomy, of infrainguinal stenoses and occlusions.. Reason: Potential for breaches in the sterile barrier packaging, compromising sterility assurance..
- Recalling firm
- Northeast Scientific Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2025-08-29
- Firm location
- Waterbury, CT, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
NES Reprocessed 0.9mm OTW Turbo Elite Laser Atherectomy Catheter. Model Number: R-410-152. The NES Reprocessed Turbo-Elite Laser Atherectomy Catheter is indicated for use in the treatment, including atherectomy, of infrainguinal stenoses and occlusions.
Reason for recall
Potential for breaches in the sterile barrier packaging, compromising sterility assurance.
Data sourced from openFDA. This site is unofficial and independent of the FDA.