Unimed Surgical Products, Inc.: Medical Device Recall in 2012 - (Recall #: Z-2295-2012)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2012.

Data Source: FDA.

Product Description:

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 registered trademark of Medline Industries, Inc. 1-800-MEDLINE***Mundelein, IL 60060 USA Made in USA.***" Part # ES0012M -- Lot # 030509-07, 052909-02, 062309-02. Product Usage: Intended for cutting and coagulation of soft tissue.

Product Classification:

Class II

Date Initiated: June 16, 2010

Date Posted: September 5, 2012

Recall Number: Z-2295-2012

Event ID: 61982

Reason for Recall:

On 6/16/2010 Unimed Surgical Products, Inc., 10401 Belcher Road, Largo, FL 33777 initiated a recall of the Medline Industries, Inc. Electrosurgical electrodes used for cutting and coagulation of soft tissue due to concerns of sterility.

Status: Terminated

Product Quantity: 6600 each

Code Information:

Lot # 052909-05, 062309-02.

Distribution Pattern:

US Nationwide Distribution - including the state of IL.

Voluntary or Mandated:

Voluntary: Firm initiated