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 Recalled by American Contract Systems Inc Due to During an internal investigation, ACS determined that the...

Date: July 14, 2025
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, Medical Procedure kits and trays labeled as: 1) LAPAROSCOPY PACK, MODEL/ITEM NUMBER EVLP61I; 2) PELVISCOPY, MODEL/ITEM NUMBER EVPV29G.

Quantity: 1094 units

Why Was This Recalled?

During an internal investigation, ACS determined that the rationale for sterilization of certain components was not justified and therefore, some components are not fit for further sterilization according to ACS procedures. As a result, ACS is unable to confirm product sterilization assurance requirements were met.

Where Was This Sold?

This product was distributed to 2 states: IL, LA

Affected (2 states)Not affected

About American Contract Systems Inc

American Contract Systems Inc has 81 total recalls tracked by RecallDetector.

Related Recalls

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