Uromedica ProACT Implantation Instrument Set Recall: U-Channel Sheath Damage Risk
Uromedica recalls ProACT Implantation Instrument Set (Model 750041, Lot UM00650) due to potential U-channel sheath damage to implant devices during use. Affected units may cause device damage when passed through sheaths.
Lower-risk recall
Potential issue with the manufacture and inspection of U-channel sheaths in Implantation Instruments Sets. Affected U-channel sheaths may be more likely to cause damage to ProACT implant devices when passes through the sheaths.
Contact the company
What happened, in plain English
Uromedica is recalling ProACT Implantation Instrument Sets (Model 750041, Lot UM00650) because U-channel sheaths might cause damage to the implant devices when passed through them. This could lead to improper implantation or device failure. Read more at govinfonow.com/recall/68365-uromedica-proact-implantation-instrument-set-recall-u-channel-sheath-damage.
Source Summary by GovInfoNow · govinfonow.com/recall/68365-uromedica-proact-implantation-instrument-set-recall-u-channel-sheath-damage · Updated August 20, 2026 · FDA enforcement record: FDA #Z-1808-2020
Cite this page
“Uromedica ProACT Implantation Instrument Set Recall: U-Channel Sheath Damage Risk.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/68365-uromedica-proact-implantation-instrument-set-recall-u-channel-sheath-damage. Based on FDA recall #Z-1808-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1808-2020%22&limit=1).
Why it’s dangerous
The U-channel sheaths in the instrument set may not be properly manufactured or inspected, increasing the chance of damage to the ProACT implant device when it passes through the sheaths. This could result in improper implantation or device failure.
Who’s affected
Surgical teams using the ProACT Implantation Instrument Set for medical procedures are most at risk. Patients receiving the implant may be affected if the device is damaged during insertion.
How to tell if you have this one
Check for the model number 750041 and lot number UM00650 on the instrument set. The product is a reusable, steam sterilizable surgical instrument set used for implant procedures.
- Brand
Uromed: ProACT- Category
Medical device
What to do — step by step
Check Product Details
Look for model number 750041 and lot number UM00650 on the instrument set.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 5 states.
FDA distribution: “Nationwide distribution to the following states: CA, GA, FL, MI, and VA.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: California, Florida, Georgia, Michigan, Virginia.
Recall timeline
FDA terminated this recall 13 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-1808-2020 (April 10, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1808-2020 to see it in context.
- Plain-language summary written by qwen3:4b on August 20, 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.