Uromedica Recalls
2 recalls on record · May 6, 2020 to January 12, 2022 · Medical Devices
Recalls by year
20
22
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
January 12, 2022Medical DevicesFDA
Uromedica Inc. recalls UROMEDICA Implantation Instrument Set (Sheath and Sharp Trocar), REF 750041, nonsterile.
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.
May 6, 2020Medical DevicesFDA
Uromedica Inc. recalls ProACT Implantation Instrument Set, is a reusable, steam sterilizable surgical instrument set consisting of a U-Channel
Hazard: 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.