FDA Medical Device Recalls (openFDA)
Unimed Surgical Products, Inc.: Product is labeled in part: "***MEDLINE***Extended 5mm PTFE Coated Ball 5.0 (12.70cm) Length***Reorder: ES0009***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 # ES0009 -- Lot # 052709-01 Product Usage: Intended for cutting and coagulation of soft tissue.
- Recall number
- Z-2294-2012
- Recalling firm
- Unimed Surgical Products, Inc.
- Product
- Product is labeled in part: "***MEDLINE***Extended 5mm PTFE Coated Ball 5.0 (12.70cm) Length***Reorder: ES0009***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 # ES0009 -- Lot # 052709-01 Product Usage: Intended for cutting and coagulation of soft tissue.
- Status
- Terminated
- Initiated
- 2010-06-16
- Posted
- 2012-08-28
- Terminated
- 2012-08-30
- Reason
- 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.
- Root cause
- Process control
- Action
- Unimed Surgical Products, Inc. issued a Medical Device Removal letter dated June 4, 2010 to Medline Industries, Inc. The letter identified the affected product, problem and actions to be taken. Medline was instructed to quarantine any undistributed product and notify its customers of the recall. For further information, contact Unimed Surgical Product, Inc. by phone 800-531-2627 or FAX 800-886-1225.
- Quantity
- 1200 each
- Distribution
- US Nationwide Distribution - including the state of IL.
- Lot, serial or model codes
- Lot # 052709-01
- 510(k) numbers
- ["K944265","K962935"]
- PMA numbers
- not on file
- Product code
- GEI
- Firm FEI
- 1000307745
- Firm city
- Largo
- Firm state
- FL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28