Olsen Medical, MIDAS TOUCH NEEDLE ELECTRODE, WITH MODIFIED… recallZ-0140-2010 · Kentucky Packaging Service LP · initiated Sep 24, 2009
Terminated All recalls posted in November 2009
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 Kentucky Packaging Service LP 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
THERE WERE INCONSISTENCIES NOTICED ON THE INSULATION OVERLAP. THE ELECTRODE HAS A LARGE DIAMETER SHAFT THAT TRANSITIONS TO A SMALLER DIAMETER SHAFT. THE 1ST LAYER OF INSULATION WHICH COVERS THE SMALL DIAMETER SHAFT OVERLAPS WITH THE 2ND LAYER OF INSULATION THAT COVERS THE LARGER DIAMETER SHAFT. ON SOME ELECTRODES IT APPEARS THAT THE OVERLAP IS TOO SHORT TO COVER THE TRANSITION WHICH MAKES THIS
FDA root cause category: Process control
What the company is doing
Olsen Medical issued an "Urgent: Device Recall" letter to Consignees beginning September 24, 2009 . Customers were instructed to inventory their stock and for all remaining product immediately discontinue use and return. Consignees were also instructed to contact their customers and notify them of the recall. For further information, contact Olsen Medical at 1-502-772-4272.
Recall details
- Recall number
- Z-0140-2010
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Sep 24, 2009
- Posted by the FDA
- Nov 10, 2009
- Recalling firm
- Kentucky Packaging Service LP
- Quantity
- 3,617 pieces
- Product code
- GEI
- FDA submissions
- K973234
- Distribution
- Nationwide Distribution -- AZ, FL, IA, MD, MO, NM, OR, NV, TN, TX and VA.
Product description
Olsen Medical, MIDAS TOUCH NEEDLE ELECTRODE, WITH MODIFIED TIP. Model Numbers: 30-1011, 30-1012, 30-1013, 30-1014 and 30-6011.
Code information (models, lots, serial numbers)
Model Number: 30-1011, Lot Numbers: 011898, 012733, 012988 and 013373; Model Number: 30-1012, Lot Number: 012244; Model Number: 30-1013, all lots; Model Number: 30-1014, Lot Numbers: 011668, 011970 and 012997; and Model Number: 30-6011, Lot Numbers: 012565, 012800 and 012983.
Other devices under the same FDA submission
1 device cleared under K973234 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Symmetry Olsen 30-0014Aspen Surgical Products, 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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