Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

American Contract Systems Laparoscopy Litho Std Pack convenience kit and Recalled by American Contract Systems, Inc. Due to Product released with insufficient aeration time impacting the...

Date: May 6, 2024
Company: American Contract Systems, Inc.
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact American Contract Systems, Inc. directly.

Affected Products

American Contract Systems Laparoscopy Litho Std Pack convenience kit and American Contract Systems Lap Chole convenience kit

Quantity: 120

Why Was This Recalled?

Product released with insufficient aeration time impacting the kits sterilized on the same cycle or in the same aeration chamber, which may have been compromised in sterility

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About American Contract Systems, Inc.

American Contract Systems, Inc. has 90 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report