Class II — Potential Health Hazard

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

ENT Recalled by American Contract Systems, Inc. Due to ACS identified that due to an inoperable chart...

Date: August 7, 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

ENT, COEN27N; Medical convenience kit

Quantity: 66 units

Why Was This Recalled?

ACS identified that due to an inoperable chart recorder, humidity readings were out-of-specification in one of the controlled environment areas. As a result, ACS is unable to confirm product sterilization assurance requirements were met.

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