FDA Medical Device Recalls (openFDA)
Encision, Inc.: AEM Fixed-Tip Needle Electrode - 5mm, Reusable REF/CAT ES3521B
- Recall number
- Z-0470-03
- Recalling firm
- Encision, Inc.
- Product
- AEM Fixed-Tip Needle Electrode - 5mm, Reusable REF/CAT ES3521B
- Status
- Terminated
- Initiated
- 2003-01-15
- Posted
- 2003-01-30
- Terminated
- 2003-04-14
- Reason
- Reports of needle fixed-tip electrodes becoming loose or breaking off.
- Root cause
- Other
- Action
- All consignees will be notified by phone or visit beginning 01/15/2003.
- Quantity
- 58 devices.
- Distribution
- Domestic distribution to LA, MA, MN, OR, UT and WA.
- Lot, serial or model codes
- Catalog # ES3521B. Lots FI, GC, GH, GL, HH, HI.
- 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