FDA Medical Device Recalls (openFDA)
Encision, Inc.: ES0110, AEM Disposable Hook Scissors, 35cm, Sterile R, Encision Inc., Boulder, CO 80301 Cutting tissue during electrosurgical procedures
- Recall number
- Z-2397-2011
- Recalling firm
- Encision, Inc.
- Product
- ES0110, AEM Disposable Hook Scissors, 35cm, Sterile R, Encision Inc., Boulder, CO 80301 Cutting tissue during electrosurgical procedures
- Status
- Terminated
- Initiated
- 2011-04-07
- Posted
- 2011-05-31
- Terminated
- 2011-08-09
- Reason
- Sterility may be compromised due to holes in packaging.
- Root cause
- Package design/selection
- Action
- Encision, Inc. sent an Important Safety Notice letter dated April 7, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to either carefully inspect any remaining pouches for readily visible holes in the Tyvek pouch, or return the affected lots to Encision for inspection. Customers were also asked to fill in and fax back the attached Confirmation to 303-444-2693.
- Quantity
- 129 Ten-Count Boxes
- Distribution
- Worldwide Distribution - USA (nationwide) and the countries of Australia and New Zealand
- Lot, serial or model codes
- Lot # QJD, QKB, QLB, RAE, RBC
- 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