Progressive Medical Recalls PTFE Coated Laparoscopic Electrosurgical Electrodes
Progressive Medical is recalling PTFE coated laparoscopic electrosurgical electrodes because the 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, but the source text does not report any injuries, illnesses, or specific physical hazards, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Progressive Medical, Inc. is recalling 19 boxes (114 units total) of PTFE Coated Disposable Electrosurgical Electrodes - Laparoscopic Electrode PTFE Coated J Hook 33cm Length, Product number P0021. The recall is being conducted because the product coatings require 510K approval.
The affected units are identified by Lot number 082712-09. These devices were distributed nationwide to facilities 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 facilities should stop using the affected electrodes and contact Progressive Medical, Inc. for instructions on return or replacement.
The recalled product
- Product
- Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes - Laparoscopic Electrode PTFE Coated J Hook 33cm Length, Product number P0021, Rx Only. Sterilized by Radiation. Manufactured for Progressive Medical, Inc., St. Louis, MO 63128. Electrodes used in…
- 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 082712-09
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 Disposable Electrosurgical Electrodes
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- ModerateProgressive Medical Recalls PTFE Coated Electrosurgical Electrodes
FDA (Devices) · 2013-05-29
- ModerateProgressive Medical Recalls PTFE Coated Electrosurgical Electrodes
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- HighProgressive Medical Recalls PTFE Coated Disposable Electrosurgical Electrodes
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