The Recall Desk
ModerateFDA (Devices)·Z-1360-2013·Announced 2013-05-29

Progressive Medical Recalls PTFE Coated Laparoscopic Electrosurgical Electrodes

Progressive Medical is recalling PTFE coated laparoscopic electrosurgical electrodes because the product coatings require 510K approval.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, but the source text does not report any injuries, illnesses, or specific physical hazards, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

Progressive Medical, Inc. is recalling 19 boxes (114 units total) of PTFE Coated Disposable Electrosurgical Electrodes - Laparoscopic Electrode PTFE Coated J Hook 33cm Length, Product number P0021. The recall is being conducted because the product coatings require 510K approval.

The affected units are identified by Lot number 082712-09. These devices were distributed nationwide to facilities 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 facilities should stop using the affected 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 J Hook 33cm Length, Product number P0021, Rx Only. Sterilized by Radiation. Manufactured for Progressive Medical, Inc., St. Louis, MO 63128. Electrodes used in Elect

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 082712-09

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 →