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American Contract Systems, Inc.

American Contract Systems, Inc. Recalls

All product recalls associated with American Contract Systems, Inc..

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Recall Summary

Total Recalls

134

Past Year

Class I (Serious)

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 121–134 of 134 recalls

American Contract Systems, Inc.: Various Pacemaker Packs, Cardio Thoracic Packs

Product was exposed to multiple sterilization cycles without validation for multiple exposures.

Moderate

FDAJun 16, 2022Nationwide• American Contract Systems, Inc.

American Contract Systems, Inc.: Various neurology packs

Product was exposed to multiple sterilization cycles without validation for multiple exposures.

Moderate

FDAJun 16, 2022Nationwide• American Contract Systems, Inc.

American Contract Systems, Inc.: Various Angiography packs/trays

Product was exposed to multiple sterilization cycles without validation for multiple exposures.

Moderate

FDAJun 16, 2022Nationwide

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• American Contract Systems, Inc.

American Contract Systems, Inc.: Various Cysto Packs

Product was exposed to multiple sterilization cycles without validation for multiple exposures.

Moderate

FDAJun 16, 2022Nationwide• American Contract Systems, Inc.

American Contract Systems, Inc.: Various eye packs, cataract packs

Product was exposed to multiple sterilization cycles without validation for multiple exposures.

Moderate

FDAJun 16, 2022Nationwide• American Contract Systems, Inc.

American Contract Systems, Inc.: Various Angiography/Cath Lab packs/trays

Product was exposed to multiple sterilization cycles without validation for multiple exposures.

Moderate

FDAJun 16, 2022Nationwide• American Contract Systems, Inc.

American Contract Systems, Inc.: Various Laparoscopy Packs

Product was exposed to multiple sterilization cycles without validation for multiple exposures.

Moderate

FDAJun 16, 2022Nationwide• American Contract Systems, Inc.

American Contract Systems, Inc.: Clean Catch Urine Kit NS 178489, AHMU58A

Affected products were assembled off-site by individuals who may not have been properly trained.

Moderate

FDAMay 2, 2022IN, MN• American Contract Systems, Inc.

American Contract Systems, Inc.: Nasopharyngeal sample collection tray for COVID-19 testin...

Affected products were assembled off-site by individuals who may not have been properly trained.

Moderate

FDAMay 2, 2022IN, MN• American Contract Systems, Inc.

American Contract Systems, Inc.: ACS Cath Lab Pack

Product was sterilized with a higher than specification EO concentration.

Moderate

FDAMar 22, 2022Nationwide• American Contract Systems, Inc.

American Contract Systems, Inc.: ACS Lap Chole Pack

Product was sterilized with a higher than specification EO concentration.

Moderate

FDAMar 22, 2022Nationwide• American Contract Systems, Inc.

American Contract Systems, Inc.: 1) ACS Arthroscopy Kit 2) ACS Knee Kit 3) ACS Hand Pack

Product was sterilized with a higher than specification EO concentration.

Moderate

FDAMar 22, 2022Nationwide• American Contract Systems, Inc.

American Contract Systems, Inc.: 1) ACS Spine Pack 2) ACS Lumbar/Back Set Up Tray

Product was sterilized with a higher than specification EO concentration.

Moderate

FDAMar 22, 2022Nationwide• American Contract Systems, Inc.

American Contract Systems, Inc.: ACS IR - Angio Pack

Product was sterilized with a higher than specification EO concentration.

Moderate

FDAMar 22, 2022Nationwide• American Contract Systems, Inc.