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.
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 1/5 (Low).
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.
- Manufacturer
- Epimed International
- Hazard
- Affected units
- 1,374
Distribution
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.
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