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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

1000

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 1881–1900 of 21320 recalls

Paracentesis Kit (American Contract) - Humidity Control Failure (2024)

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.

Moderate

FDAAug 7, 2024Nationwide• American Contract Systems, Inc.

Airvo 3 Respiratory Device (Fisher & Paykel) - High Pressure Oxygen Risk (2024)

Due to a software issue, affected devices that are set up with High Pressure Oxygen (HPO), if the flow alignment alarm occurs, the device will deliver room air only. If this happens, a patient my experience oxygen desaturation that could lead to hypoxia.

High

FDAAug 7, 2024AZ, CA, CO +26 more• Fisher & Paykel Healthcare, Ltd. 15 Maurice Paykel Place East Tamaki Auckland New Zealand

Infusomat Space Pump (B Braun) - Occlusion Sensor Malfunction (2024)

Extension of previous recall RES 92978. Pumps have the potential for upstream occlusion sensor to cease proper function due to buildup of electrostatic charge during operation triggering false downstream and upstream occlusion alarms. Additional devices have been affected.

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High

FDAAug 7, 2024AL, CA, GA +3 more• B Braun Medical Inc

Tubal Ligation Pack (American Contract) - Humidity Control Failure (2024)

Moderate

FDAAug 7, 2024Nationwide• American Contract Systems, Inc.

MAKO Cutting System Handpiece (Howmedica) - Characterization Process Issue (2024)

Stryker has identified an issue with the characterization process that impacted the constant values assigned to the associated MICS Handpieces.

Low

FDAAug 7, 2024Nationwide• Howmedica Osteonics Corp.

Cath Lab Pack CECL02P (American Contract Systems) – Humidity Issue (2024)

Moderate

FDAAug 7, 2024Nationwide• American Contract Systems, Inc.

Day Surgery General Pack FHGE18T (American Contract Systems) – Humidity Issue (2024)

Moderate

FDAAug 7, 2024Nationwide• American Contract Systems, Inc.

Hydrocortisone Otic Solution (Taro) – Impurity Specification Failure (2024)

Failed Impurities/Degradation Specifications: Out-of-specification results obtained for related impurities and slightly lower than the established level of the Hydrocortisone Assay obtained during stability testing.

Class IIILow

FDAAug 7, 2024Nationwide• Taro Pharmaceuticals U.S.A., Inc.

Shoulder Medical Kit (American Contract) - Humidity Control Failure (2024)

Moderate

FDAAug 7, 2024Nationwide• American Contract Systems, Inc.

FilmArray Torch Module (BioFire) - Calibration Equipment Problem (2024)

Salmonella

Some automated in vitro diagnostic modules and instruments manufactured or serviced between May 2022 and May 2024 were calibrated with internal equipment that may lead modules and instruments to report higher melting temperatures, which may lead to erroneous results including false positive Salmonella, Giardia lamblia, false positive/negative Norovirus, and false negative MRSA.

Moderate

FDAAug 7, 2024Nationwide• BioFire Diagnostics, LLC

LVP Primary Administration Set (Cypress Medical) – Medication Flow Risk (2024)

The syringes that were inadvertently shipped from the Distribution Center. This product was on quarantine because FDA has stated that these syringes lack FDA clearance and were inadvertently shipped due to an internal order processing error.

Moderate

FDAAug 6, 2024Nationwide• Cypress Medical Products LLC

Azurion 7M20 Systems (Philips) – FlexArm Movement Issue (2024)

The motorized longitudinal movement of the FlexArm stand may be inconsistent (not smooth) and eventually may become unavailable. This issue is due to grease leakage from the bearings and/or anti-corrosion oil applied on the bearings, because of which the lubrication on the ceiling rail may be excessive, reducing the friction between the rails and the friction wheel.

High

FDAAug 6, 2024Nationwide• PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands

Custom GMRS Extension Piece (Howmedica) – Design Mismatch (2024)

A patient specific, custom-made device was supplied for a surgical procedure that did not match the design proposal.

Low

FDAAug 5, 2024Nationwide• Howmedica Osteonics Corp.

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American Contract Systems, Inc. Recalls

Recall Summary

Paracentesis Kit (American Contract) - Humidity Control Failure (2024)

Airvo 3 Respiratory Device (Fisher & Paykel) - High Pressure Oxygen Risk (2024)

Infusomat Space Pump (B Braun) - Occlusion Sensor Malfunction (2024)

Tubal Ligation Pack (American Contract) - Humidity Control Failure (2024)

MAKO Cutting System Handpiece (Howmedica) - Characterization Process Issue (2024)

Cath Lab Pack CECL02P (American Contract Systems) – Humidity Issue (2024)

Day Surgery General Pack FHGE18T (American Contract Systems) – Humidity Issue (2024)

Hydrocortisone Otic Solution (Taro) – Impurity Specification Failure (2024)

Shoulder Medical Kit (American Contract) - Humidity Control Failure (2024)

FilmArray Torch Module (BioFire) - Calibration Equipment Problem (2024)

Essentia Laparotomy Pack (American Contract) - Humidity Control Failure (2024)

Pacemaker Pack (American Contract) - Humidity Control Failure (2024)

Pacemaker Kit (American Contract) - Humidity Control Failure (2024)

Arthroscopy Pack MSKA45A (American Contract Systems) – Humidity Issue (2024)

Hand Pack AKHD97C (American Contract Systems) – Humidity Issue (2024)

Nasal Sinus Pack MTSN26B (American Contract Systems) – Humidity Issue (2024)

ENT COEN27N (American Contract Systems) – Humidity Issue (2024)

LVP Primary Administration Set (Cypress Medical) – Medication Flow Risk (2024)

Azurion 7M20 Systems (Philips) – FlexArm Movement Issue (2024)

Custom GMRS Extension Piece (Howmedica) – Design Mismatch (2024)