AEM Fixed-Tip L-Diamond Electrode, 5mm, Reusable recallZ-1074-04 · Encision, Inc. · initiated Jun 11, 2004
Terminated All recalls posted in September 2004
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
Electrosurgical tip may break or come off during use.
FDA root cause category: Other
What the company is doing
Customers were notified beginning 6/15/2004 by phone or visit.
Recall details
- Recall number
- Z-1074-04
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Jun 11, 2004
- Posted by the FDA
- Sep 22, 2004
- Recalling firm
- Encision, Inc.
- Quantity
- 335 units
- Product code
- GEI
- FDA submissions
- K912780
- Distribution
- AL, CT, GA, IA, MN, MS, NC, OK, OR, TN, WA. Foreign distribution to Canada and Australia.
Product description
AEM Fixed-Tip L-Diamond Electrode, 5mm, Reusable.
Code information (models, lots, serial numbers)
Catalog ES3511B, Lots EKA, FB, FE, FI, FL, GA, GC, GF, GH, GI, GIA, GL, GLA, HC, HCA, HE.
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
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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