The Recall Desk
HighFDA (Devices)·Z-1355-2013·Announced 2013-05-29

Progressive Medical Recalls PTFE Coated Laparoscopic Electrodes

Progressive Medical is recalling PTFE coated laparoscopic electrodes because the 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 FDA classified this as a Class II recall, which indicates a reasonable probability of temporary or medically reversible adverse health consequences. The rubric maps Class II recalls without specific hospitalization reports to a High severity score.

Plain-English summary

Progressive Medical, Inc. is recalling PTFE Coated Disposable Electrosurgical Electrodes, specifically the Laparoscopic Electrode PTFE Coated Curved Blade 33cm Length (Product number P0019). The recall involves 38 boxes containing 6 units each, identified by Lot number 071212-04. These electrodes are used in electrosurgeries and were sterilized by radiation.

The recall is being conducted because the product coatings require 510K approval. The FDA has classified this recall as Class II. The affected units 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.

Healthcare providers and consumers should stop using these specific electrodes and contact Progressive Medical, Inc. for instructions on return or replacement.

The recalled product

Product
Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes -Laparoscopic Electrode PTFE Coated Curved Blade 33cm Length, Product number P0019 Rx Only. Sterilized by Radiation. Manufactured for Progressive Medical, Inc., St. Louis, MO 63128. Electrodes used in El

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 071212-04

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 →