Progressive Medical Recalls PTFE Coated Disposable Electrosurgical Electrodes
Progressive Medical is recalling PTFE coated disposable electrosurgical electrodes because product coatings require 510K approval.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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 does not report any illnesses, injuries, or specific physical hazards, fitting the criteria for a moderate severity recall.
Plain-English summary
Progressive Medical, Inc. is recalling PTFE Coated Disposable Electrosurgical Electrodes, Product number P0014M. The recall involves 27 boxes containing 12 units each. The product is a non-stick cautery tip with a PTFE modified coated blade, 6.5 inches (16.51 cm) in length, sterilized by radiation.
The recall was initiated because product coatings require 510K approval. The affected units were distributed nationwide, including to 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 the affected electrodes and contact Progressive Medical, Inc. for further instructions.
The recalled product
- Product
- Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes -NON-STICK CAUTERY TIP PTFE Modified Coated Blade 6.5" (16.51cm) Length, Product number P0014M Rx Only. Sterilized by Radiation. Manufactured for Progressive Medical, Inc., St. Louis, MO 63128.…
- Manufacturer
- Progressive Medical Inc
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 082712-04
Distribution
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 →Related recalls
Same manufacturer · Progressive Medical Inc
See all →- ModerateProgressive Medical Recalls PTFE Coated Disposable Electrosurgical Electrodes
FDA (Devices) · 2013-05-29
- ModerateProgressive Medical Recalls PTFE Coated Electrosurgical Electrodes
FDA (Devices) · 2013-05-29
- ModerateProgressive Medical Recalls PTFE Coated Electrosurgical Electrodes
FDA (Devices) · 2013-05-29
- HighProgressive Medical Recalls PTFE Coated Disposable Electrosurgical Electrodes
FDA (Devices) · 2013-05-29
- HighProgressive Medical Recalls PTFE Coated Disposable Electrosurgical Electrodes
FDA (Devices) · 2013-05-29
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