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Open, Classified

GENERAL LAPAROSCOPIC PACK-LF , Model No UTGL53S-06 UTGL53S-07 UTGL53S-08

FDA Recall Z-1357-2025 · Posted 2025-03-14

Recalling FirmAmerican Contract Systems Inc
Recall StatusOpen, Classified
Product CodeLRO
Date Initiated2025-02-06
Product Quantity534 kits

Reason for Recall

ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.

Firm Action

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.

Root Cause

Process control

Distribution Pattern

US Nationwide distribution in the state of OH.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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