Skip to main content

Is My Product Recalled?

Food Recalls Medication Recalls Baby Products Pet Products Toys Electronics Household Vehicles Medical Devices Other

Scan How It Works Saved Get Alerts

Menu

Search All Recalls Latest Recalls Scan Barcode Get Alerts

Categories

Food Recalls Medication Recalls Baby Products Pet Products Toys Electronics Household Vehicles Medical Devices Other

Resources

How Recalls Work FAQ Recall Classifications Statistics & Trends About

Your Recalls

Loading...

Stay Informed

Get email alerts when new recalls match your interests.

Recall data is updated hourly from official government sources. Very recent recalls may not yet appear. About our data sources

About

We make U.S. recall data searchable and accessible for consumers and businesses.

Site

FAQ
Browse by State
Statistics
Recall Classifications
About
Enterprise API

Legal

Privacy Policy
Terms of Service
Report Incorrect Info

Official Sources

FDA Recalls ↗
USDA FSIS ↗
CPSC Recalls ↗
NHTSA Recalls ↗

Home
/
Brands
/
American Contract Systems Inc.

American Contract Systems Inc. Recalls

All product recalls associated with American Contract Systems Inc..

Get alerts for this brand

Recall Summary

Total Recalls

134

Past Year

40

Class I (Serious)

0

Most Recent

Sep 2025

Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.

Showing 1–20 of 134 recalls

Medical Convenience Kit (American Contract Systems) – Sterilization Error (2025)

Identified products were re-gassed (sterilized more than once) after a nonconformance occurred during the initial Ethylene Oxide (EO) gas injection process. These products have not been validated for exposure to multiple sterilization cycles. Therefore, product quality, safety, and effectiveness cannot be confirmed for product that was re-gassed.

FDASep 4, 2025Nationwide• American Contract Systems Inc.

Medical Convenience Kit (American Contract Systems) – Sterilization Error (2025)

Identified products were re-gassed (sterilized more than once) after a nonconformance occurred during the initial Ethylene Oxide (EO) gas injection process. These products have not been validated for exposure to multiple sterilization cycles. Therefore, product quality, safety, and effectiveness cannot be confirmed for product that was re-gassed.

FDASep 4, 2025Nationwide• American Contract Systems Inc.

Medical Convenience Kit (American Contract Systems) – Sterilization Error (2025)

Previous

12 3...7

Page 1 of 7Next

Identified products were re-gassed (sterilized more than once) after a nonconformance occurred during the initial Ethylene Oxide (EO) gas injection process. These products have not been validated for exposure to multiple sterilization cycles. Therefore, product quality, safety, and effectiveness cannot be confirmed for product that was re-gassed.

Moderate

FDASep 4, 2025Nationwide• American Contract Systems Inc.

Basic Biopsy Tray (American Contract Systems) – Sterilization Error (2025)

Identified products were re-gassed (sterilized more than once) after a nonconformance occurred during the initial Ethylene Oxide (EO) gas injection process. These products have not been validated for exposure to multiple sterilization cycles. Therefore, product quality, safety, and effectiveness cannot be confirmed for product that was re-gassed.

FDASep 4, 2025Nationwide• American Contract Systems Inc.

American Contract Systems Kits (ACS) – Sterilization Concern (2025)

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.

FDAJul 14, 2025IL, LA• American Contract Systems Inc

Lower Extremity Implant (American Contract) – EO/ECH Residuals (2025)

Test results for cast padding component included in procedure trays shows Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals exceeded residual limits, which may lead to a possible loss or lack of functionality that may lead to a delay or prolonged treatment/procedure/therapy.

FDAApr 21, 2025Nationwide• American Contract Systems, Inc.

Major Vascular Pack (American Contract) – sterilization uncertainty (2025)

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

FDAFeb 6, 2025Nationwide• American Contract Systems Inc

AV Fistula (American Contract) – sterilization uncertainty (2025)

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

FDAFeb 6, 2025Nationwide• American Contract Systems Inc

Total Hip Pack (American Contract) – sterilization uncertainty (2025)

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

FDAFeb 6, 2025Nationwide• American Contract Systems Inc

Laparoscopy Pack (American Contract) – sterilization uncertainty (2025)

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

FDAFeb 6, 2025Nationwide• American Contract Systems Inc

Vein Tray (American Contract) – sterilization uncertainty (2025)

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

FDAFeb 6, 2025Nationwide• American Contract Systems Inc

Hip Scope (American Contract) – sterilization uncertainty (2025)

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

FDAFeb 6, 2025Nationwide• American Contract Systems Inc

C-Section Pack (American Contract) – sterilization uncertainty (2025)

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

FDAFeb 6, 2025Nationwide• American Contract Systems Inc

Labor & Delivery Pack (American Contract) – sterilization uncertainty (2025)

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

FDAFeb 6, 2025Nationwide• American Contract Systems Inc

Spine Lumbar Pack (American Contract) – sterilization uncertainty (2025)

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

FDAFeb 6, 2025Nationwide• American Contract Systems Inc

Laparoscopy Pack (American Contract) – sterilization uncertainty (2025)

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

FDAFeb 6, 2025Nationwide• American Contract Systems Inc

General Laparoscopic Pack (American Contract) – sterilization uncertainty (2025)

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

FDAFeb 6, 2025Nationwide• American Contract Systems Inc

Diagnostic Neuro IR Tray (American Contract) – sterilization uncertainty (2025)

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

FDAFeb 6, 2025Nationwide• American Contract Systems Inc

Thoracic Pack (American Contract) – sterilization uncertainty (2025)

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

FDAFeb 6, 2025Nationwide• American Contract Systems Inc

DR Diulus Injection Pack (American Contract) – sterilization uncertainty (2025)

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

FDAFeb 6, 2025Nationwide• American Contract Systems Inc