The Recall Desk
LowFDA (Devices)·Z-1849-2020·Announced 2020-05-13

Epimed RF Injector Cannula Recalled for Incorrect Expiration Date

Epimed International is recalling 1,374 units of RF Injector Cannulas due to incorrect expiration dates on the packaging.

What this means for you

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: The recall is due to a documentation and packaging error (incorrect expiration date) with no reported injuries or illnesses, fitting the criteria for a Low severity recall.

Plain-English summary

Epimed International is recalling 1,374 units of R-F Injector Cannulas (Catalog #257-1810 and #257-1810D) because the packaging displays incorrect expiration dates. The product is a sterile medical device intended for use in radiofrequency heat lesion procedures for the relief of pain.

The recall covers specific sterile lots with expiration dates ranging from February 2023 to September 2024. The affected units were distributed worldwide, including nationwide in the United States and in Australia, Chile, and the United Kingdom.

Healthcare providers and consumers should stop using the affected cannulas and contact Epimed International for further instructions or a replacement.

The recalled product

Product
R-F Injector Cannula. 18gx10cm-STERILE. REF/UDI: 257-1810/(01)00828788021496; REF/UDI: 257-1810D(01)10818788021493 - Product Usage: The Epimed RF Introduction Cannula is intended for use in radiofrequency (RF) heat lesion procedures for the relief of pain.
Affected units
1,374

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 →