FDA Medical Device Recalls (openFDA)
Encision, Inc.: AEM Fixed-Tip L-Diamond Electrode, 5mm, Reusable.
- Recall number
- Z-1074-04
- Recalling firm
- Encision, Inc.
- Product
- AEM Fixed-Tip L-Diamond Electrode, 5mm, Reusable.
- Status
- Terminated
- Initiated
- 2004-06-11
- Posted
- 2004-09-22
- Terminated
- 2004-11-09
- Reason
- Electrosurgical tip may break or come off during use.
- Root cause
- Other
- Action
- Customers were notified beginning 6/15/2004 by phone or visit.
- Quantity
- 335 units
- Distribution
- AL, CT, GA, IA, MN, MS, NC, OK, OR, TN, WA. Foreign distribution to Canada and Australia.
- Lot, serial or model codes
- Catalog ES3511B, Lots EKA, FB, FE, FI, FL, GA, GC, GF, GH, GI, GIA, GL, GLA, HC, HCA, HE.
- 510(k) numbers
- ["K912780"]
- 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