Z-1849-2020Class II

R-F Injector Cannula. 18gx10cm-STERILE. REF/UDI: 257-1810/(01)00828788021496; REF/UDI...

Name: Z-1849-2020 R-F Injector Cannula. 18gx10cm-STERILE. REF/UDI: 257-1810/(01)00828788021496; REF/UDI...
Creator: Epimed International
Published: 2020-02-21
License: https://open.fda.gov/license/

Epimed International, Inc. / initiated 2020-02-21 / Terminated / root cause: labeling and UDI

FDA source

Epimed International began a recall of R-F Injector Cannula. 18gx10cm-STERILE. REF/UDI: 257-1810/(01)00828788021496; REF/UDI: 257-1810D(01)10818788021493 - Product Usage: The Epimed RF Introduction... on 2020-02-21. FDA classified it as Class II and gives the reason as "Incorrect expiration date on introduction cannula packaging". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1849-2020
Classification: Class II
Status: Terminated
Initiated: 2020-02-21
Posted: 2020-04-16
Terminated: 2021-01-28
Recalling firm: Epimed International, Inc.
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.
Product code: GXI Probe, Radiofrequency Lesion
Reason for recall: Incorrect expiration date on introduction cannula packaging.
Root cause tag: labeling and UDI
FDA root cause: Labeling design
Action: On 02/21/2020, URGENT: MEDICAL DEVICE RECALL letters were sent to customers by way of Standard U.S. Mail services.
Quantity in commerce: 1374
Distribution: Worldwide distribution - US Nationwide distribution including the states of AL, CA, FL, GA, IL, MD,MI, MS, NJ, NY, OK, TN, TX, WA and WY and the countries of Australia, Chile, United Kingdom.
Product codes and lots: Catalog #257-1810 Sterile Lot #/Expiration Date/ 1. 14108679/exp. 3-29-23/ 2. 14109199/exp. 1-21-24/ 3. 14108568/exp. 2-4-23/ Catalog #257-1810D Sterile Lot #/Expiration Date/ 1. 14109199/ exp. 1-21-24/ 2. 14109690/exp. 9-26-24/

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1849-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1849-2020	Class II	Terminated	Voluntary: Firm initiated	2020-05-13	2020-05-04
Z-1850-2020	Class II	Terminated	Voluntary: Firm initiated	2020-05-13	2020-05-04

Product code GXI

K041021Class IIRF Introduction CannulaEpimed International, Inc. / cleared 2004-09-16

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)