Neurotherm Curved Radiofrequency Cannula Recalled for Mislabeling
Neurotherm, Inc. is recalling 135 curved radiofrequency cannulas because straight needles were incorrectly labeled as curved.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard is a labeling error (straight needle labeled as curved) without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Neurotherm, Inc. is recalling 135 units of the Neurotherm Curved Radiofrequency (RF) cannula, 10 cm, 18 gauge, 10 mm active tip, Model Number C-1010-R-18. The recall was initiated because straight needles were incorrectly labeled as curved needles. The device is a radiofrequency needle used for the application of radiofrequency energy to achieve thermo coagulation of nervous tissue for pain relief.
The affected product, identified by Lot number 12131-1C, was distributed nationwide in the United States, specifically in the states of California, Colorado, Ohio, and Oregon. The recall involves 27 boxes containing a total of 135 cannulas.
Healthcare providers and consumers should stop using the affected devices immediately. Neurotherm, Inc. is the recalling firm responsible for managing this recall. Users should contact the manufacturer for further instructions on how to return or dispose of the mislabeled products.
The recalled product
- Product
- Neurotherm Curved Radiofrequency (RF) cannnula 10 cm 18 gauge, 10 mm active tip Model Number: C-1010-R-18 Product Usage: The device is a radiofrequency needle, used for the application of radiofrequency energy with as intended result, thermo coagulation of nervous tissue…
- Manufacturer
- Neurotherm, Inc.
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot number: 12131-1C
Distribution
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