The Recall Desk
ModerateFDA (Devices)·Z-1349-2013·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 illnesses, injuries, or hospitalizations, and the hazard is regulatory (missing 510K approval) rather than a direct physical injury risk.

Plain-English summary

Progressive Medical, Inc. is recalling PTFE Coated Disposable Electrosurgical Electrodes, Product number P0014. The recall involves 19 boxes containing 12 units each, 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 specific lot number is 071212-03.

The reason for the recall is that product coatings require 510K approval. The source text does not provide further details on the specific nature of the coating defect or any reported injuries.

Healthcare providers and consumers should stop using the affected electrodes and contact Progressive Medical, Inc. for further instructions or a return.

The recalled product

Product
Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes - NON-STICK CAUTERY TIP PTFE Coated Blade 6.5" (16.51cm) Length, Product number P0014, Rx Only. Sterilized by Radiation. Manufactured for Progressive Medical, Inc., St. Louis, MO 63128. Electrodes used i

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 071212-03

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 →