Use cautionMedical device recall · FDA · Published November 22, 2021
Uromedica Implantation Instrument Set Recall: Risk of Device Damage During Surgery
Uromedica recalls specific implantation instrument sets (REF 750041) due to potential damage to ProACT devices during surgery. Affected units have lot numbers UM00794 or UM00817.
The U-channel sheaths may cause damage to ProACT implant devices when the devices are passed through the sheath during a ProACT implantation procedure.
Take action
Contact the company
📍Recalling firmUromedica Inc.1840 Berkshire Ln N · Plymouth, MN 55441-3723
“Uromedica Implantation Instrument Set Recall: Risk of Device Damage During Surgery.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61508-uromedica-implantation-instrument-set-recall-risk-of-device-damage-during. Based on FDA recall #Z-0458-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0458-2022%22&limit=1).
Uromedica Inc. recalled the UROMEDICA Implantation Instrument Set (Sheath and Sharp Trocar), REF 750041, nonsterile, due to a potential for device damage, according to the Food and Drug Administration on November 22, 2021.
How to tell if you have it
Brand: Uromedica
Product: UROMEDICA Implantation Instrument Set (Sheath and Sharp Trocar)
REF: 750041
Lot numbers: UM00794, UM00817
UDI: 00180668000106
Quantity: 18 devices
The hazard
The U-channel sheaths may cause damage to ProACT implant devices when the devices are passed through the sheath during a ProACT implantation procedure.
Context
GovInfoNow's records show Uromedica Inc. has one other recall on record since April 10, 2019. Other recent recalls of similar products include Olympus HX-400U-30 Ligating Device Recall (October 30, 2025), Medtronic Bio-Medicus Adult Cannula Kit Recall (May 25, 2026), and Medtronic DLP Retrograde Cannula Recall (April 21, 2026).
How to tell if you have this one
Check for lot numbers UM00794 or UM00817 on the UROMEDICA Implantation Instrument Set (REF 750041). The product is nonsterile and sold under UDI 00180668000106.
Brand
Uromedica
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Product Details
Identify the lot number on the instrument set to confirm if it's affected (UM00794 or UM00817).
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 7 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “US Nationwide distribution in the states of AZ, CA, CO, KS, MD, TX, and WI.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Arizona, California, Colorado, Kansas, Maryland, Texas, Wisconsin.
Recall timeline
FDA terminated this recall 21 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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-0458-2022 (November 22, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0458-2022 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 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.