The Recall Desk
ModerateFDA (Devices)·Z-1247-2016·Announced 2016-03-30

Neurotherm Curved Radiofrequency Cannula Recalled for Mislabeling

Neurotherm, Inc. is recalling 135 curved radiofrequency cannulas because straight needles were incorrectly labeled as curved.

What this means for you

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.

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

Distributed nationwide across the United States.

The notice also names 4 states specifically:

Same manufacturer · Neurotherm, Inc.

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