The Recall Desk
ModerateFDA (Devices)·Z-1359-2013·Announced 2013-05-29

Progressive Medical Recalls PTFE Coated Disposable Electrosurgical Electrodes

Progressive Medical Inc. 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, but the source text does not report any injuries, illnesses, or specific physical hazards, aligning with the rubric for moderate severity involving regulatory or labeling issues without reported harm.

Plain-English summary

Progressive Medical Inc. is recalling PTFE Coated Disposable Electrosurgical Electrodes, specifically the Laparoscopic Electrode PTFE Coated Wire L Hook Split 33cm Length (Product number P0020S). The recall involves 20 boxes containing 6 units each, identified by Lot number 082712-07. The products were distributed nationwide to specific states including AR, AZ, CA, CO, FL, ID, IL, IN, KS, KY, LA, MA, MI, MN, MO, NE, OH, OK, OR, TN, TX, WA, and WI.

The reason for the recall is that the product coatings require 510K approval. The source text does not specify any reported injuries, illnesses, or specific safety hazards associated with the use of these electrodes.

Healthcare facilities and consumers who have these products should stop using them and contact Progressive Medical Inc. for further instructions on return or disposal.

The recalled product

Product
Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes - Laparoscopic Electrode PTFE Coated Wire L Hook Split 33cm Length,Product number P0020S Rx Only. Sterilized by Radiation. Manufactured for Progressive Medical, Inc., St. Louis, MO 63128. Electrodes use

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 082712-07

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 →