The Recall Desk
ModerateFDA (Devices)·Z-1357-2013·Announced 2013-05-29

Progressive Medical Recalls PTFE Coated Laparoscopic Electrosurgical Electrodes

Progressive Medical is recalling PTFE Coated Disposable 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, and the source text cites a regulatory compliance issue (missing 510K approval) rather than a specific physical hazard or reported injury, fitting the criteria for a moderate severity precautionary recall.

Plain-English summary

Progressive Medical, Inc. is recalling PTFE Coated Disposable Electrosurgical Electrodes, specifically the Laparoscopic Electrode PTFE Coated Spatula 33cm Length (Product number P0018). The recall involves 16 boxes containing 6 units each, identified by Lot number 082712-05.

The recall was initiated because the product coatings require 510K approval. The devices are sterilized by radiation and are intended for use in electrosurgeries.

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 facilities should stop using these specific units and contact Progressive Medical for instructions on return or replacement.

The recalled product

Product
Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes - Laparoscopic Electrode PTFE Coated Spatula 33cm Length, Product number P0018 Rx Only. Sterilized by Radiation. Manufactured for Progressive Medical, Inc., St. Louis, MO 63128. Electrodes used in Electr

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 082712-05

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 →