The Recall Desk
HighFDA (Devices)·Z-2295-2012·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 are intended for cutting and coagulation of soft tissue.

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 and involves a risk-of-harm product (sterility failure in a surgical device) where specific injury reports are not detailed in the source text, fitting the High severity criteria.

Plain-English summary

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

The recalled products are labeled as "Standard PTFE Coated Blade with Extended Insulation 2.50 (6.40cm) Length" with reorder number ES0012M. The specific lots affected include 030509-07, 052909-02, 062309-02, 052909-05, and 062309-02. A total of 6,600 units were distributed nationwide, including the state of Illinois.

Healthcare providers and consumers should stop using these specific electrosurgical electrodes immediately. Users should check their inventory for the listed lot numbers and contact Unimed Surgical Products or Medline Industries for further instructions on how to return or dispose of the affected units.

The recalled product

Product
Product is labeled in part: "***MEDLINE***Standard PTFE Coated Blade with Extended Insulation 2.50 (6.40cm) Length***Reorder: ES0012M***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
6,600

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 (2)

  • Lot # 052909-05
  • 062309-02.

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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