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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

1000

Past Year

353

Class I (Serious)

Most Recent

Jan 2026

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 341–360 of 3680 recalls

Laceration 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.

Moderate

FDAFeb 6, 2025Nationwide• American Contract Systems Inc

Aortic Root Cannula (Medtronic) – luer material issue (2025)

Unexpected loose material in the male luer used in the aortic root cannula has been identified. Potential harms when identified prior to use - procedure delay. Potential harm if not identified and used - stroke (reversible and irreversible).

High

FDAFeb 5, 2025Nationwide• Medtronic Perfusion Systems

IntelePACS Software (Intelerad) – image calculation error (2025)

A software application that receives digital images and data from various sources has a bug in specific software versions that will calculate the Standard Uptake Value (SUV) incorrectly for PET/CT studies acquired on the days of Daylight Savings Time (DST); only on dates in which DST transition occurs; all other dates are unaffected. An incorrect SUV may lead to an incorrect diagnosis.

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High

FDAFeb 5, 2025Nationwide• INTELERAD MEDICAL SYSTEMS INCORPORATED 800, Boul. de Maisonneuve Est 12th floor Montreal Canada

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

During an internal investigation, ACS was unable to confirm that the CODMAN component achieved the required Sterility Assurance Level and therefore is not suitable for sterilization according to ACS procedures.

Moderate

FDAFeb 4, 2025MI• American Contract Systems Inc

VOCSN Ventilators (Ventec) – servicing part issue (2025)

Multi-Function Ventilators were serviced using incorrect parts which have the potential to cause unexpected shutdown, or when using an active circuit could result in inaccurate tidal volume monitor, not triggering on patient efforts, less inspiratory volume, less inspiratory pressure, and less PEEP delivered.

High

FDAFeb 3, 2025CA, IN, MO +1 more• Ventec Life Systems, Inc.

Cardiac Cath Lab Pack (Banner) – sterility assurance (2025)

Sterility assurance with procedure trays

Low

FDAJan 31, 2025AZ• American Contract Systems, Inc.

Cysto Pack (Banner Health) – sterility assurance (2025)

Sterility assurance with procedure trays

Low

FDAJan 31, 2025AZ• American Contract Systems, Inc.

Leica CM1950 Cryostat (Leica) – firmware data loss (2025)

Firm became aware of software issues related to most recent firmware update which could result in loss of patient tissue.

High

FDAJan 30, 2025Nationwide• LEICA BIOSYSTEMS NUSSLOCH GMBH Heidelberger Str. 17-19 Nussloch Germany

Discovery XR656HD X-Ray System (GE) – exposure limit (2025)

The user can continue to take the next exposure after reaching the Automatic Exposure Control (AEC) limit, without taking any further actions to acknowledge or adjust exposure techniques. In all cases, a message still appears on the screen when the AEC limit is reached.

Moderate

FDAJan 28, 2025Nationwide• GE Medical Systems, LLC

Prelude IDEAL Sheath Introducer (Merit) – incorrect dilator (2025)

Hydrophilic Sheath Introducer labeled for 4F dilators may instead incorrectly contain 5F dilators. Incorrect dilator use may result in procedure delay.

Low

FDAJan 27, 2025Nationwide• Merit Medical Systems, Inc.

Infinity Central Station (Draeger) – Speaker Malfunction (2025)

Edifier speakers (shipped in or after April 2023) may not annunciate when configured in analog mode which can lead to delayed treatment to the patient.

High

FDAJan 14, 2025Nationwide• Draeger Medical Systems, Inc.

Allura CV20 (Philips) – Safety Issue (2025)

Potential safety issue with the AD7 and AD7X patient tables (both tilt and non-tilt versions) part of the Philips Allura and Azurion systems. During manual repositioning of the patient tabletop, a finger can get entrapped between the longitudinal guiding rails and the tabletop. This may result in an injury of the finger, applicable for operators and service personnel

High

FDAJan 13, 2025Nationwide• PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands