FDA Device recall Z-1348-2013
Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes - NON-STICK CAUTERY TIP PTFE Modified Coated Needle 2.75" (6.99cm) Le…
- FDA Device
- Class II
- terminated
- Published 2013-05-29
On 2013-05-29 the FDA classified a Class II recall of Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes - NON-STICK CAUTERY TIP PTFE Modified Coated Needle 2.75" (6.99cm) Le… by Progressive Medical, citing product coatings require 510K approval.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1348-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-04-12 |
| Published | 2013-05-29 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Progressive Medical |
| Distribution | US |
Product
Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes - NON-STICK CAUTERY TIP PTFE Modified Coated Needle 2.75" (6.99cm) Length, Product number P0013M, Rx Only. Sterilized by Radiation. Manufactured for Progressive Medical, Inc., St. Louis, MO 63128. Electrodes used in Electrosurgeries
Reason
Product coatings require 510K approval.
Identifiers
| code_info | Lot number 071212-02 |
|---|
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-1348-2013%22
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