Z-0069-2010

Extended PTFE Coated Blade electrosurgical electrodes, 6.5" (16.51CM) Length, 12 each & 20 each per box...

Name: Z-0069-2010 Extended PTFE Coated Blade electrosurgical electrodes, 6.5" (16.51CM) Length, 12 each & 20 each per box...
Creator: Unimed Surgical Products, Inc.
Published: 2009-08-28
License: https://open.fda.gov/license/

Unimed Surgical Products, Inc. / initiated 2009-08-28 / Terminated / root cause: manufacturing process

FDA source

Unimed Surgical Products, Inc. began a recall of Extended PTFE Coated Blade electrosurgical electrodes, 6.5" (16.51CM) Length, 12 each & 20 each per box, Labeled MEDLINE brand. Manufactured for Medline... on 2009-08-28. The reason FDA records is "Unimed Surgical Products, Inc., Largo, FL initiated a voluntary recall of the Extended PTFE Coated Blade electrosurgical electrodes, product number ES0014, due to concerns regarding product sterility for Lot #042209-03". 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-0069-2010
Status: Terminated
Initiated: 2009-08-28
Posted: 2009-10-21
Terminated: 2010-05-12
Recalling firm: Unimed Surgical Products, Inc.
Product: Extended PTFE Coated Blade electrosurgical electrodes, 6.5" (16.51CM) Length, 12 each & 20 each per box, Labeled MEDLINE brand. Manufactured for Medline Industries, Inc. Mundelein, IL 60060 USA Made in USA MEDLINE in a registered trademark of Medline Industries, Inc. 1-800-MEDLINE.
Product code: GEI Electrosurgical, Cutting & Coagulation & Accessories
Reason for recall: Unimed Surgical Products, Inc., Largo, FL initiated a voluntary recall of the Extended PTFE Coated Blade electrosurgical electrodes, product number ES0014, due to concerns regarding product sterility for Lot #042209-03.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Unimed Surgical Products, Inc. issued a Medical Device Removal letter dated August 28, 2009. The customer, Medline Industries, Inc., was instructed to quarantine any undistributed product and to notify its customers of the recall. For further information, contact Unimed Surgical Products, Inc. at 1-727-546-1900 or 1-800-886-1225.
Quantity in commerce: 1920 units
Distribution: Nationwide Distribution -- MI
Product codes and lots: Product Order No. ES0014, Lot Number: 042209-03.

Product code GEI

K962935Class IIUnimed Coated Needle Electrode/coated Blade Electrode/coated Ball ElectrodeUnimed Surgical Products, Inc. / cleared 1996-09-03

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)