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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 85339

2 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
February 21, 2020
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Epimed International

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

2 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 2

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.

Z-1849-2020
Recall number
Z-1849-2020
Initiated
February 21, 2020
Classification
Class II
Status
Terminated
Recalling firm
Epimed International
Quantity
1374

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Incorrect expiration date on introduction cannula packaging.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Incorrect expiration date on introduction cannula packaging.

Code information

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/

Distribution pattern

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.

device · product 2 of 2

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.

Z-1850-2020
Recall number
Z-1850-2020
Initiated
February 21, 2020
Classification
Class II
Status
Terminated
Recalling firm
Epimed International
Quantity
701

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Incorrect expiration date on introduction cannula packaging.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Incorrect expiration date on introduction cannula packaging.

Code information

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/

Distribution pattern

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.