FDA Device recall Z-2286-2012
Product is labeled in part: "***MEDLINE***Extended PTFE Needle 6.5" (16.51cm) Length***Reorder: ES0016***Contents: 1 Each***SINGLE USE ONLY…
- FDA Device
- Class II
- terminated
- Published 2012-09-05
On 2012-09-05 the FDA classified a Class II recall of Product is labeled in part: "***MEDLINE***Extended PTFE Needle 6.5" (16.51cm) Length***Reorder: ES0016***Contents: 1 Each***SINGLE USE ONLY… by Unimed Surgical Products, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2286-2012 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2010-06-16 |
| Published | 2012-09-05 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Unimed Surgical Products |
| Distribution | US |
Product
Product is labeled in part: "***MEDLINE***Extended PTFE Needle 6.5" (16.51cm) Length***Reorder: ES0016***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 # ES0016 -- Lot #: 030608-01 and 121808-19. Product Usage: Intended for cutting and coagulation of soft tissue.
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.
Identifiers
| code_info | Lot #s: 030608-01, 121808-19. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2286-2012%22
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