Z-0140-2010

Olsen Medical, MIDAS TOUCH NEEDLE ELECTRODE, WITH MODIFIED TIP. Model Numbers: 30-1011, 30-1012, 30-1013...

Name: Z-0140-2010 Olsen Medical, MIDAS TOUCH NEEDLE ELECTRODE, WITH MODIFIED TIP. Model Numbers: 30-1011, 30-1012, 30-1013...
Creator: Kentucky Packaging Service LP
Published: 2009-09-24
License: https://open.fda.gov/license/

Olsen Medical / initiated 2009-09-24 / Terminated / root cause: manufacturing process

FDA source

Kentucky Packaging Service LP began a recall of Olsen Medical, MIDAS TOUCH NEEDLE ELECTRODE, WITH MODIFIED TIP. Model Numbers: 30-1011, 30-1012, 30-1013, 30-1014 and 30-6011 on 2009-09-24. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0140-2010
Status: Terminated
Initiated: 2009-09-24
Posted: 2009-11-10
Terminated: 2010-10-05
Recalling firm: Olsen Medical
Product: Olsen Medical, MIDAS TOUCH NEEDLE ELECTRODE, WITH MODIFIED TIP. Model Numbers: 30-1011, 30-1012, 30-1013, 30-1014 and 30-6011.
Product code: GEI Electrosurgical, Cutting & Coagulation & Accessories
Reason for recall: 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
Root cause tag: manufacturing process
FDA root cause: Process control
Action: 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.
Quantity in commerce: 3,617 pieces
Distribution: Nationwide Distribution -- AZ, FL, IA, MD, MO, NM, OR, NV, TN, TX and VA.
Product codes and lots: 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.

Product code GEI

K973234Class IIMidas Touch Electrosurgical ElectrodeIti Medical Technologies, Inc. / cleared 1997-10-27

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)