The Recall Desk
ModerateFDA (Devices)·Z-1358-2013·Announced 2013-05-29

Progressive Medical Recalls PTFE Coated 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, but the source text does not report any injuries, illnesses, or deaths, and the hazard is related to regulatory approval rather than a direct physical defect causing harm.

Plain-English summary

Progressive Medical, Inc. is recalling PTFE Coated Disposable Electrosurgical Electrodes, specifically the Laparoscopic Electrode PTFE Coated Wire L Hook 44cm Length (Product number P0100X). The recall involves 60 boxes containing 6 units each, with lot numbers 071212-07 and 082712-14. The products were sterilized by radiation and distributed nationwide to 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 recall was initiated because the product coatings require 510K approval. The source text does not report any specific injuries, illnesses, or deaths associated with the use of these devices.

Healthcare facilities and consumers who have these specific lot numbers should stop using the electrodes and contact Progressive Medical, Inc. for further instructions on return or replacement.

The recalled product

Product
Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes - Laparoscopic Electrode PTFE Coated Wire L Hook 44cm Length, Product number P0100X Rx Only. Sterilized by Radiation. Manufactured for Progressive Medical, Inc., St. Louis, MO 63128. Electrodes used in E

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 numbers 071212-07 and 082712-14

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 →