FDA Medical Device Recalls (openFDA)
Encision, Inc.: Encision AEM Suction Irrigation Electrode, Needle Tip, REF ES3885, Encision Inc., Boulder, CO 80301.
- Recall number
- Z-3097-2011
- Recalling firm
- Encision, Inc.
- Product
- Encision AEM Suction Irrigation Electrode, Needle Tip, REF ES3885, Encision Inc., Boulder, CO 80301.
- Status
- Terminated
- Initiated
- 2011-08-24
- Posted
- 2011-08-30
- Terminated
- 2012-09-04
- Reason
- Electrode tips have been reported breaking off during use or cleaning.
- Root cause
- Device Design
- Action
- Encision Inc. sent out an "Urgent Product Recall" letter dated August 24, 2011 to all affected customers. The letter included: affected product, problem and instructed customers to discontinue use and return all affected electrodes to Encision. An enclosed reply form was to be faxed back to Encision indicating status of firm's inventory. For information on this recall call Encision at (303) 339-6917.
- Quantity
- 10 units
- Distribution
- Worldwide Distribution: Nationwide distribution, and the country of New Zealand.
- Lot, serial or model codes
- Catalog: REF ES3885. Lots: QI and RA.
- 510(k) numbers
- ["K100711"]
- PMA numbers
- not on file
- Product code
- GEI
- Firm FEI
- 1000117361
- Firm city
- Boulder
- Firm state
- CO
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28