American Contract Systems Inc LACERATION TRAY , Model No SGLA07A SGLA07B-01 SGLA07B-02 SGLA07B Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
LACERATION TRAY , Model No SGLA07A SGLA07B-01 SGLA07B-02 SGLA07B
Brand
American Contract Systems Inc
Lot Codes / Batch Numbers
UDI-DI 00191072135063 00191072223715 Lots 899241 70-050880 70-051697 70-052161 70-052662
Products Sold
UDI-DI 00191072135063 00191072223715 Lots 899241 70-050880 70-051697 70-052161 70-052662
American Contract Systems Inc is recalling LACERATION TRAY , Model No SGLA07A SGLA07B-01 SGLA07B-02 SGLA07B due to ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged . Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.
Recommended Action
Per FDA guidance
The affected distributor was notified via email on 2/16/25, and an updated letter was provided on 2/18/25. The distributor was instructed to notify their end users. Customers were provided with a list of impacted components which are included in the affected trays. Customers were provided with a labeling template and instructed to add warning labels to affected procedure trays to ensure the affected components are discarded.
Verify this information on the official source
This page aggregates publicly available data. Always confirm recall details directly with the U.S. Food and Drug Administration (FDA) before taking action.
View official FDA recall noticePage updated: Jan 10, 2026
Important Notice
This page displays information sourced from the U.S. Food and Drug Administration (FDA). IsMyProductRecalled.com aggregates public data for convenience and does not issue recalls. We are not affiliated with any government agency. Always verify recall information with the official source before taking action. This is not medical or legal advice.