Cosman Medical Nitinol TC Reusable Electrodes Recall: Risk of Incomplete Cleaning After
Cosman Medical recalls Nitinol TC Reusable Electrodes (TCN) models 10, 15, 20, 5 with specific lot numbers due to potential damage to epoxy resin after reprocessing, which may cause incomplete cleaning and tissue residuals.
Lower-risk recall
After multiple reprocessing cycles, the epoxy resin which holds the TCN Electrode in the hub can exhibit signs of damage. In some cases, this damage may result in the inability to fully remove blood and/or tissue residuals prior to cleaning and re-sterilizing the device.
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What happened, in plain English
Cosman Medical is recalling Nitinol TC Reusable Electrodes (TCN) models 10, 15, 20, and 5 with specific lot numbers because repeated reprocessing can damage the epoxy resin holding the electrode in place. This damage might prevent proper cleaning and sterilization, leading to tissue or blood residuals that could cause infection or injury during future use. Read more at govinfonow.com/recall/73461-cosman-medical-nitinol-tc-reusable-electrodes-recall-risk-of-incomplete.
Source Summary by GovInfoNow · govinfonow.com/recall/73461-cosman-medical-nitinol-tc-reusable-electrodes-recall-risk-of-incomplete · Updated September 21, 2026 · FDA enforcement record: FDA #Z-0687-2018
Cite this page
“Cosman Medical Nitinol TC Reusable Electrodes Recall: Risk of Incomplete Cleaning After.” GovInfoNow, updated September 21, 2026. https://govinfonow.com/recall/73461-cosman-medical-nitinol-tc-reusable-electrodes-recall-risk-of-incomplete. Based on FDA recall #Z-0687-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0687-2018%22&limit=1).
Why it’s dangerous
After multiple reprocessing cycles, the epoxy resin that holds the electrode in the hub can become damaged. This damage may prevent the device from fully removing blood and tissue residuals before cleaning and re-sterilizing, potentially leading to infection or injury during subsequent use.
Who’s affected
Healthcare professionals using these electrodes for radiofrequency nerve procedures are most at risk if they reprocess the devices multiple times without proper cleaning. The recall affects specific model numbers and lot numbers listed in the official notice.
How to tell if you have this one
Check the model number and lot number on the electrode. The affected models include TCN-10, TCNK-10-R, TCN-10-3M, TCNK-15, TCN-15, TCN-20, TCN-5, and others with specific lot numbers listed in the recall notice.
- Brand
Cosman Medical- Category
Medical device
What to do — step by step
Check Model and Lot Numbers
Identify the model number and lot number on the electrode to determine if it is affected by this recall.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
FDA distribution: “Worldwide Distribution: US (nationwide) and country of Canada.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA terminated this recall 14 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-0687-2018 (July 5, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0687-2018 to see it in context.
- Plain-language summary written by qwen3:4b on September 21, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.