Z-1808-2020Class II

ProACT Implantation Instrument Set, is a reusable, steam sterilizable surgical instrument set consisting of a...

Name: Z-1808-2020 ProACT Implantation Instrument Set, is a reusable, steam sterilizable surgical instrument set consisting of a...
Creator: Uromedica Inc.
Published: 2019-04-10
License: https://open.fda.gov/license/

Uromedica Inc. / initiated 2019-04-10 / Terminated / root cause: manufacturing process

FDA source

Uromedica Inc. began a recall of ProACT Implantation Instrument Set, is a reusable, steam sterilizable surgical instrument set consisting of a U-Channel Sheath through which the Pro ACT... on 2019-04-10. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1808-2020
Classification: Class II
Status: Terminated
Initiated: 2019-04-10
Posted: 2020-04-28
Terminated: 2020-05-18
Recalling firm: Uromedica Inc.
Product: ProACT Implantation Instrument Set, is a reusable, steam sterilizable surgical instrument set consisting of a U-Channel Sheath through which the Pro ACT balloon implant is introduced.
Product code: KOA Surgical Instruments, G-U, Manual (And Accessories)
Reason for 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.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Uromedica sent a notification to the customers via email and letter instructing them to identify the affected sets and returned them to Uromedica within 10 business days. Uromedica will provide for the return shipping of the affected tool set and replace if free of charge.
Quantity in commerce: 11 tool sets
Distribution: Nationwide distribution to the following states: CA, GA, FL, MI, and VA.
Product codes and lots: Model 750041, Lot # UM00650

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1808-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1808-2020	Class II	Terminated	Voluntary: Firm initiated	2020-05-06	2020-04-28

Product code KOA

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)