ES0101, AEM Disposable Curved Scissors, 1/2", 35cm, Sterile… recallZ-2395-2011 · Encision, Inc. · initiated Apr 7, 2011
Terminated All recalls posted in May 2011
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Encision, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Sterility may be compromised due to holes in packaging.
FDA root cause category: Package design/selection
What the company is doing
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.
Recall details
- Recall number
- Z-2395-2011
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Apr 7, 2011
- Posted by the FDA
- May 31, 2011
- Recalling firm
- Encision, Inc.
- Quantity
- 574 Ten-Count Boxes, 24 Kits
- Product code
- GEI
- FDA submissions
- K912780
- Distribution
- Worldwide Distribution - USA (nationwide) and the countries of Australia and New Zealand
Product description
ES0101, AEM Disposable Curved Scissors, 1/2", 35cm, Sterile R, Encision Inc., Boulder, CO 80301 Cutting tissue during electrosurgical procedures
Code information (models, lots, serial numbers)
Lot # QJC, QKD, QLE, RAG, RBD
Other devices under the same FDA submission
3 devices cleared under K912780 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Insert, Wave Grasper ES0537Encision, Inc. · Electrosurgical, Cutting & Coagulation & Accessories2 reports
- Fixed Tip Electrode, J-Hook ES3510BEncision, Inc. · Electrosurgical, Cutting & Coagulation & Accessories1 report
- Insert, Curved Scissors ES0002Encision, Inc. · Electrosurgical, Cutting & Coagulation & Accessories1 report
Other products in the same recall event
The FDA groups related products into one recall event (event 58518).
- Z-2396-2011 · TerminatedES0102, AEM Disposable Curved Scissors, 3/4", 35cm, Sterile R, Encision Inc., Boulder, CO 80301 Cutting tissue during electrosurgical procedures
- Z-2397-2011 · TerminatedES0110, AEM Disposable Hook Scissors, 35cm, Sterile R, Encision Inc., Boulder, CO 80301 Cutting tissue during electrosurgical procedures
- Z-2398-2011 · TerminatedES0120, AEM Disposable Low Profile Scissors, 3/4", 35cm, Sterile R, Encision Inc., Boulder, CO 80301 Cutting tissue during electrosurgical procedures
- Z-2399-2011 · TerminatedES0101-45, AEM Disposable Curved Scissors, 1/2", 45cm, Sterile R, Encision Inc., Boulder, CO 80301 Cutting tissue during electrosurgical procedures
- Z-2400-2011 · TerminatedES0102-45, AEM Disposable Curved Scissors, 3/4", 45cm, Sterile R, Encision Inc., Boulder, CO 80301 Cutting tissue during electrosurgical procedures
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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