FDA Medical Device Recalls (openFDA)
Uromedica Inc.: UROMEDICA Implantation Instrument Set (Sheath and Sharp Trocar), REF 750041, nonsterile.
- Recall number
- Z-0458-2022
- Recalling firm
- Uromedica Inc.
- Product
- UROMEDICA Implantation Instrument Set (Sheath and Sharp Trocar), REF 750041, nonsterile.
- Status
- Terminated
- Initiated
- 2021-11-22
- Posted
- not on file
- Terminated
- 2023-08-11
- Reason
- The U-channel sheaths may cause damage to ProACT implant devices when the devices are passed through the sheath during a ProACT implantation procedure.
- Root cause
- Nonconforming Material/Component
- Action
- 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.
- Quantity
- 18 devices
- Distribution
- US Nationwide distribution in the states of AZ, CA, CO, KS, MD, TX, and WI.
- Lot, serial or model codes
- Lot numbers UM00794 and UM00817, UDI 00180668000106
- 510(k) numbers
- not on file
- PMA numbers
- ["P130018"]
- Product code
- EZY
- Firm FEI
- 3003477176
- Firm city
- Plymouth
- Firm state
- MN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28