Northeast Scientific Inc. is recalling 3,669 units of its Reprocessed Turbo-Elite Laser Atherectomy Catheters due to potential breaches in the sterile barrier packaging. The recall affects several models (OTW and RX) in sizes ranging from 0.9mm to 2.0mm that have expiration dates before August 29, 2026. These catheters are used in medical facilities for treating blockages in leg arteries, and a compromise in the sterile packaging could lead to infection.
A breach or tear in the packaging can compromise the sterility of the catheter. Using a non-sterile device during an arterial procedure could introduce bacteria or contaminants directly into a patient's bloodstream, posing a risk of serious infection.
Recall #: Z-0018-2026. Quantity: 561 units.
Recall #: Z-0019-2026. Quantity: 173 units. This model is not cleared for marketing in the US.
Recall #: Z-0020-2026. Quantity: 165 units. This model is not cleared for marketing in the US.
Recall #: Z-0021-2026. Quantity: 199 units. This model is not cleared for marketing in the US.
Recall #: Z-0022-2026. Quantity: 795 units. This model is not cleared for marketing in the US.
Recall #: Z-0023-2026. Quantity: 1,019 units. This model is not cleared for marketing in the US.
Recall #: Z-0024-2026. Quantity: 616 units. This model is not cleared for marketing in the US.
Recall #: Z-0025-2026. Quantity: 141 units. This model is not cleared for marketing in the US.
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.
Sources: FDA iRES · Raw API Response
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