The Recall Desk
HighFDA (Devices)·Z-2296-2012·Announced 2012-09-05

Unimed Recalls Medline Electrosurgical Electrodes Due to Sterility Concerns

Unimed Surgical Products is recalling Medline electrosurgical electrodes due to sterility concerns. The affected units were distributed nationwide in the US.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a risk-of-harm product (sterility failure in a surgical device) where injury has not yet been reported, fitting the High severity criteria.

Plain-English summary

Unimed Surgical Products, Inc. initiated a recall of Medline Industries, Inc. electrosurgical electrodes on June 16, 2010. The recall was initiated due to concerns regarding the sterility of the devices. These electrodes are intended for the cutting and coagulation of soft tissue.

The specific product involved is the Extended PTFE Coated Blade with Extended Insulation, 6.5 (16.51cm) Length, Reorder Number ES0014M. The recall covers 3,600 units from Lot # 050609-05, 052909-05, and 062309-04. The products were distributed nationwide in the United States, including the state of Illinois.

Healthcare providers and facilities should stop using the affected electrosurgical electrodes and contact Unimed Surgical Products for further instructions. Consumers should not use these medical devices if they have them in their possession.

The recalled product

Product
Product is labeled in part: "***MEDLINE***Extended PTFE Coated Blade with Extended Insulation 6.5 (16.51cm) Length***Reorder: ES0014M***Contents: 1 Each***SINGLE USE ONLY**latexfree***RX Only***STERILE EO***www.medline.com Manufactured for Medline Industries, Inc. MEDLINE is a
Manufacturer
Unimed Surgical Products, Inc.
Category
Medical Device — Electrosurgical Instruments
Hazard
Affected units
3,600

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (3)

  • Lot # 050609-05
  • 052909-05
  • 062309-04.

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 11 recalled by Unimed Surgical Products, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 11 products in this recall →

Related recalls

Same manufacturer · Unimed Surgical Products, Inc.

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Same hazard · sterility failure

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