The Recall Desk
ModerateFDA (Devices)·Z-1850-2020·Announced 2020-05-13

Epimed RF Injector Cannula Recalled for Incorrect Expiration Date Labeling

Epimed International is recalling 701 units of R-F Injector Cannulas due to incorrect expiration dates on the packaging. The devices were distributed worldwide and across multiple US states.

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, but the specific hazard is a minor labeling error (incorrect expiration date) without reported injuries or illnesses, fitting the 'Moderate' criteria for minor labeling errors.

Plain-English summary

Epimed International is recalling 701 units of R-F Injector Cannulas (Catalog #257-2010 and #257-2010D) because the packaging displays incorrect expiration dates. The affected sterile lots include 14108680, 14108569, and 14109200, with expiration dates ranging from February 2023 to January 2024. The agency has classified this as a Class II recall.

The recalled cannulas are intended for use in radiofrequency heat lesion procedures for the relief of pain. The distribution pattern includes worldwide distribution, as well as US nationwide distribution in states including Alabama, California, Florida, Georgia, Illinois, Maryland, Michigan, Mississippi, New Jersey, New York, Oklahoma, Tennessee, Texas, Washington, and Wyoming. International distribution includes Australia, Chile, and the United Kingdom.

Consumers and healthcare providers should stop using the affected devices and contact Epimed International for further instructions. This recall is driven by a labeling error regarding the expiration date, which may affect the verification of the device's sterility and shelf life.

The recalled product

Product
R-F Injector Cannula. 20gx10cm-STERILE. REF/UDI: 257-2010/(01)10818788022124; REF/UDI: 257-2010D(01)00818788022127 - Product Usage:The Epimed RF Introduction Cannula is intended for use in radiofrequency (RF) heat lesion procedures for the relief of pain.
Affected units
701

Distribution

Distributed nationwide across the United States.

The notice also names 15 states specifically:

Part of a larger recall action

This product is one of 2 recalled by Epimed International under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →