FDA Medical devices recall ·
NES Reprocessed 0.9mm OTW Turbo Elite Laser Atherectomy Catheter recall
- Recall number
- Z-0018-2026
- Date
- (initiated August 29, 2025)
- Company / brand
- Northeast Scientific Inc.
2142 Thomaston Ave, Waterbury, CT, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 561 units
- Hazard tags
- Sterility
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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.
Why was it recalled?
Potential for breaches in the sterile barrier packaging, compromising sterility assurance.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Model No R-410-152; UDI-DI 00850044399055; All Lot Numbers that are within their labeled shelf life with expiration dates prior to 29AUG2026
Distribution
US Nationwide distribution to CA, FL, IL, KS, LA, MD, MI, MO, NC, NJ, NM, NV, NY, PA, TN, TX, VA.
States: California Florida Illinois Kansas Louisiana Maryland Michigan Missouri North Carolina New Jersey New Mexico Nevada New York Pennsylvania Tennessee Texas Virginia
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-0018-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.