CLASS II Device recall · Reported 13 May 2020 · FDA Enforcement Report

R-F Injector Cannula recalled by Epimed International

Epimed International is recalling R-F Injector Cannula, distributed nationwide in the US. The recall was initiated on 21 Feb 2020 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesCatalog #257-2010 Sterile Lot #/Expiration Date/ 1. 14108680/exp. 3-29-23/ 2. 14108569/exp. 2-4-23/ 3. 14109200/exp. 1-21-24 Catalog #257-2010D Sterile Lot #/Expiration Date/ 1. 14109200/exp. 1-21-24/

Quantity recalled701

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1850-2020
FDA event ID: 85339
Recalling firm: Epimed International, Farmers Branch, TX
Classification: Class II
Status: Terminated
Recall initiated: 21 Feb 2020
FDA classified: 4 May 2020
Reported: 13 May 2020
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Sterility
Device type: Heart & Vascular Devices

Timeline

21 Feb 2020	Recall initiated by company
4 May 2020	Classified by FDA	+73 days
13 May 2020	Published in enforcement report	+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Incorrect expiration date on introduction cannula packaging.

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

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.

Where it was distributed

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.

Nationwide Alabama California Florida Georgia Illinois Maryland Michigan Mississippi New Jersey New York Oklahoma Tennessee Texas Washington Wyoming

Questions about this recall

Is R-F Injector Cannula recalled?

Yes. Epimed International recalled R-F Injector Cannula on 21 Feb 2020. The recall is Class II and its status is Terminated. Recall number Z-1850-2020.

Why was it recalled?

Incorrect expiration date on introduction cannula packaging.

Which lots are affected?

Catalog #257-2010 Sterile Lot #/Expiration Date/ 1. 14108680/exp. 3-29-23/ 2. 14108569/exp. 2-4-23/ 3. 14109200/exp. 1-21-24 Catalog #257-2010D Sterile Lot #/Expiration Date/ 1. 14109200/exp. 1-21-24/

Where was it sold?

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.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Epimed International

All 11

Reported	Class	Recall	Company	Reason	Where
25 Aug 2021Device	CLASS II	Neo-kath Epidural Catheter Set recalled by Epimed International	Epimed International	Sterility	Nationwide
25 Aug 2021Device	CLASS II	Neo-kath(TM) Caudal Set recalled by Epimed International	Epimed International	Sterility	Nationwide
24 Mar 2021Device	CLASS II	Feth-R-Kath Catheter recalled by Epimed International	Epimed International	Device Malfunction	Nationwide
13 May 2020Device	CLASS II	R-F Injector Cannula recalled by Epimed International	Epimed International	Sterility	Nationwide
31 Jul 2019Device	CLASS II	Versa - Kath Mini Kit, with plastic L.O.R Syringe, Sterile ED recalled	Epimed International	Labeling Errors	8 states

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All 6,190

Reported	Class	Recall	Company	Reason	Where
9 Sep 2026Device	CLASS II	Presource Packs Containing CliniClean Pericare Wipes within recalled	Cardinal Health 200	Other	Nationwide
9 Sep 2026Device	CLASS II	Presource Packs Containing CliniClean Pericare Wipes within recalled	Cardinal Health 200	Other	Nationwide
9 Sep 2026Device	CLASS II	Presource Packs Containing CliniClean Pericare Wipes within recalled	Cardinal Health 200	Other	Nationwide
9 Sep 2026Device	CLASS II	Presource Packs Containing CliniClean Pericare Wipes within recalled	Cardinal Health 200	Other	Nationwide
9 Sep 2026Device	CLASS II	Presource Packs Containing CliniClean Pericare Wipes within recalled	Cardinal Health 200	Other	Nationwide