The Recall Desk
ModerateFDA (Devices)·Z-1348-2013·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 cites a regulatory compliance issue (510K approval) rather than a specific safety hazard or reported injury, aligning with a moderate severity for voluntary or compliance-driven recalls.

Plain-English summary

Progressive Medical Inc. is recalling PTFE Coated Disposable Electrosurgical Electrodes, specifically the NON-STICK CAUTERY TIP PTFE Modified Coated Needle 2.75" (6.99cm) Length, Product number P0013M. The recall involves 28 boxes containing 12 units each, identified by Lot number 071212-02. These electrodes are used in electrosurgeries and are sterilized by radiation.

The recall was initiated because product coatings require 510K approval. 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 further instructions or a refund.

The recalled product

Product
Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes - NON-STICK CAUTERY TIP PTFE Modified Coated Needle 2.75" (6.99cm) Length, Product number P0013M, Rx Only. Sterilized by Radiation. Manufactured for Progressive Medical, Inc., St. Louis, MO 63128. 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 071212-02

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 →