The Recall Desk
HighFDA (Devices)·Z-1353-2013·Announced 2013-05-29

Progressive Medical Recalls PTFE Coated Disposable Electrosurgical Electrodes

Progressive Medical Inc. is recalling PTFE Coated Disposable Electrosurgical Electrodes because product coatings require 510K approval.

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 the rubric assigns a score of 3 to risk-of-harm products where injury has not yet been reported.

Plain-English summary

Progressive Medical Inc. is recalling PTFE Coated Disposable Electrosurgical Electrodes, specifically the Laparoscopic Electrode PTFE Coated L Hook 44cm Length (Product number P0020X). The recall involves 20 boxes with 6 units each, identified by Lot number 082712-08.

The recall was initiated because product coatings require 510K approval. The agency has classified this recall as Class II.

The affected products were distributed nationwide, including in Arkansas, Arizona, California, Colorado, Florida, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Michigan, Minnesota, Missouri, Nebraska, Ohio, Oklahoma, Oregon, Tennessee, Texas, Washington, and Wisconsin. Consumers and healthcare facilities should stop using these products and contact Progressive Medical Inc. for further instructions.

The recalled product

Product
Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes - Laparoscopic Electrode PTFE Coated L Hook 44cm Length, Product number P0020X Rx Only. Sterilized by Radiation. Manufactured for Progressive Medical, Inc., St. Louis, MO 63128. Electrodes used in Electros

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 (1)

  • Lot number 082712-08

Distribution

Distributed nationwide across the United States.

The notice also names 23 states specifically:

Part of a larger recall action

This product is one of 17 recalled by Progressive Medical 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 17 products in this recall →