Northeast Scientific Inc. recalls NES Reprocessed 1.4mm RX Turbo Elite Laser Atherectomy Catheter. Model Number: R-414-15…
Reason for recall
Potential for breaches in the sterile barrier packaging, compromising sterility assurance.
Affected product
Check your device
Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.
NES Reprocessed 1.4mm RX Turbo Elite Laser Atherectomy Catheter. Model Number: R-414-159. The NES Reprocessed Turbo-Elite Laser Atherectomy Catheter is indicated for use in the treatment, including atherectomy, of infrainguinal stenoses and occlusions. This model is not cleared for marketing in the US.
Lot / code information
- Model
- R-414-159
- UDI
- 00850044399123; All
- Lot #
- that are within their labeled shelf life with expiration dates prior to 29AUG2026
What the firm is doing
Northeast Scientific notified consignees via an "URGENT: Medical Device Recall Notification" letter dated 8/29/2025 and email. Consignees were instructed to immediately discontinue use of affected products, quarantine and return any unused affected units, and complete and return the enclosed Recall Response Form, even if you no longer have any affected product. If product were further distributed, consignees were instructed to notify those customers immediately and ensure they also discontinue use and return the devices. Northeast Scientific will provide replacement product (if available) or credit for returned product. In addition, Northeast Scientific has initiated an investigation and is implementing corrective actions to prevent recurrence. If you have any questions or concerns, please reach out to your Northeast Scientific Sales Representative or contact us at Sales@nescientific.com or 203-756-2111.
DistributionShow detailsHide
US Nationwide distribution to CA, FL, IL, KS, LA, MD, MI, MO, NC, NJ, NM, NV, NY, PA, TN, TX, VA.
Use of the product may cause temporary or medically reversible adverse health consequences.
Sources & references
- FDA enforcement recordOfficial FDA database entry for Z-0023-2026
- FDA device classification · QTFOfficial FDA classification for this device type
- CFR regulation · 21 CFR 870.4875The federal regulation governing this device
- FDA recall announcementSearch FDA.gov for the official press announcement
- Find Northeast Scientific Inc.Search for the manufacturer's official notice
- News coverageRecent reporting on this recall and manufacturer
- openFDA data recordThe raw JSON record this page is built from
Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.
Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.
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