Recall Z-0022-2026
Northeast Scientific Inc. · initiated August 29, 2025
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
NES Reprocessed 0.9mm RX Turbo Elite Laser Atherectomy Catheter. Model/Catalog Number: R-410-154. 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.
Codes / lots: Model No R-410-154; UDI-DI 00850044399062; All Lot Numbers that are within their labeled shelf life with expiration dates prior to 29AUG2026.
Reason for recall
Potential for breaches in the sterile barrier packaging, compromising sterility assurance.
FDA-determined cause: Process control
Action taken
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.
Details
- Recall number
- Z-0022-2026
- Initiated
- August 29, 2025
- Posted by FDA
- October 2, 2025
- Product code
- QTF – Reprocessed Atherectomy Catheter
- Quantity
- 795 units
- Distribution
- US Nationwide distribution to CA, FL, IL, KS, LA, MD, MI, MO, NC, NJ, NM, NV, NY, PA, TN, TX, VA.
- Recalling firm
- Northeast Scientific Inc., Waterbury, CT
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0018-2026 Class II | NES Reprocessed 0.9mm OTW Turbo Elite Laser Atherectomy Catheter. Model Number:…Potential for breaches in the sterile barrier packaging, compromising sterility assurance. | 08/29/2025Open, Classified |
| Z-0019-2026 Class II | NES Reprocessed 1.4mm OTW Turbo Elite Laser Atherectomy Catheter. Model Number:…Potential for breaches in the sterile barrier packaging, compromising sterility assurance. | 08/29/2025Open, Classified |
| Z-0020-2026 Class II | NES Reprocessed 1.7mm OTW Turbo Elite Laser Atherectomy Catheter. Model Number:…Potential for breaches in the sterile barrier packaging, compromising sterility assurance. | 08/29/2025Open, Classified |
| Z-0021-2026 Class II | NES Reprocessed 2.0mm OTW Turbo Elite Laser Atherectomy Catheter. Model Number:…Potential for breaches in the sterile barrier packaging, compromising sterility assurance. | 08/29/2025Open, Classified |
| Z-0023-2026 Class II | NES Reprocessed 1.4mm RX Turbo Elite Laser Atherectomy Catheter. Model Number:…Potential for breaches in the sterile barrier packaging, compromising sterility assurance. | 08/29/2025Open, Classified |
| Z-0024-2026 Class II | NES Reprocessed 1.7mm RX Turbo Elite Laser Atherectomy Catheter. Model Number:…Potential for breaches in the sterile barrier packaging, compromising sterility assurance. | 08/29/2025Open, Classified |
| Z-0025-2026 Class II | NES Reprocessed 2.0mm RX Turbo Elite Laser Atherectomy Catheter. Model Number:…Potential for breaches in the sterile barrier packaging, compromising sterility assurance. | 08/29/2025Open, Classified |