AEM Fixed-Tip Needle Electrode - 5mm, Reusable recallZ-0470-03 · Encision, Inc. · initiated Jan 15, 2003
Terminated All recalls posted in January 2003
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
Reports of needle fixed-tip electrodes becoming loose or breaking off.
FDA root cause category: Other
What the company is doing
All consignees will be notified by phone or visit beginning 01/15/2003.
Recall details
- Recall number
- Z-0470-03
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Jan 15, 2003
- Posted by the FDA
- Jan 30, 2003
- Recalling firm
- Encision, Inc.
- Quantity
- 58 devices.
- Product code
- GEI
- FDA submissions
- K912780
- Distribution
- Domestic distribution to LA, MA, MN, OR, UT and WA.
Product description
AEM Fixed-Tip Needle Electrode - 5mm, Reusable REF/CAT ES3521B
Code information (models, lots, serial numbers)
Catalog # ES3521B. Lots FI, GC, GH, GL, HH, HI.
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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