UROMEDICA Implantation Instrument Set (Sheath and Sharp… recallZ-0458-2022 · Uromedica Inc. · initiated Nov 22, 2021
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Uromedica Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
The U-channel sheaths may cause damage to ProACT implant devices when the devices are passed through the sheath during a ProACT implantation procedure.
FDA root cause category: Nonconforming Material/Component
What the company is doing
Letters dated 11/22/2021 were issued via email to the consignees explaining the reason for recall. The consignee is requested to identify and remove the affected u-channel sheath and sharp trocar from circulation at their facility. The consignee will be contacted by a Uromedica representative who will schedule an in-person visit and collect the affected U-channel sheath and sharp trocar. Once the instruments have been removed from the facility, replacement instruments will be provided.
Recall details
- Recall number
- Z-0458-2022
- Status
- Terminated
- Initiated by the company
- Nov 22, 2021
- Recalling firm
- Uromedica Inc.
- Quantity
- 18 devices
- Product code
- EZY
- FDA submissions
- P130018
- Distribution
- US Nationwide distribution in the states of AZ, CA, CO, KS, MD, TX, and WI.
Product description
UROMEDICA Implantation Instrument Set (Sheath and Sharp Trocar), REF 750041, nonsterile.
Code information (models, lots, serial numbers)
Lot numbers UM00794 and UM00817, UDI 00180668000106
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- ProACT - Implantation Instrument Set 750041Uromedica Inc1 recall5 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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