American Contract Systems Inc
64 federal recalls on file. We monitor every CPSC, FDA, USDA, and NHTSA notice for American Contract Systems Inc and translate it into plain English — free weekly digest, optional same-day alerts.
- 2025-04-02FDA-DeviceClass IIBrand Name: Banner Health Systems Product Name: Cysto Pack Model/Catalog Number: BHCY31E Product Description: Convenience Kit Component: No
Sterility assurance with procedure trays
- 2025-03-26FDA-DeviceClass IICRANI PACK, Model/Catalog Number WECR41D, medical procedure kit.
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.
- 2025-03-26FDA-DeviceClass IIVEIN TRAY, Model No UTVT21C UTVT21C02 UTVT21C-03
ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.
- 2025-03-26FDA-DeviceClass IITHORACIC PACK , Model No UTTC82Y UTTC82AA-01
ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.
- 2025-03-26FDA-DeviceClass IISPINE LUMBAR PACK , Model No UTSL72AA UTSL72AB
ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.
- 2025-03-26FDA-DeviceClass IIOPEN HEART A PACK , Model No UTOH19AI UTOH19AJ-01 UTOH19AJ-02
ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.
- 2025-03-26FDA-DeviceClass IIMAJOR VASCULAR PACK , Model No UTMV78X-01 UTMV78Y UTMV78Y-01 UTMV78X-01 UTMV78Y-02
ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.
- 2025-03-26FDA-DeviceClass IIGENERAL LAPAROSCOPIC PACK-LF , Model No UTGL53S-06 UTGL53S-07 UTGL53S-08
ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.
- 2025-03-26FDA-DeviceClass IIAV FISTULA , Model No UTAV77T
ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.
- 2025-03-26FDA-DeviceClass IINEURO IR TRAY , Model No WENI56J
ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.
- 2025-03-26FDA-DeviceClass IIDIAGNOSTIC NEURO IR TRAY , Model No WENE21
ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.
- 2025-03-26FDA-DeviceClass IICV BASIC PUMP PACK , Model No WECV23D
ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.
- 2025-03-26FDA-DeviceClass IILAPAROSCOPY PACK , Model No SFLA02A SFLA02B
ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.
- 2025-03-26FDA-DeviceClass IIEAR PACK , Model No SFEA12A
ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.
- 2025-03-26FDA-DeviceClass IILACERATION TRAY , Model No SGLA07A SGLA07B-01 SGLA07B-02 SGLA07B
ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.
- 2025-03-26FDA-DeviceClass IILACERATION TRAY , Model No SGLA07A SGLA07B-01 SGLA07B-02 SGLA07B
ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.
- 2025-03-26FDA-DeviceClass IIDELIVERY PACK , Model No SGDV22D-01 SGDV22E
ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.
- 2025-03-26FDA-DeviceClass IITOTAL HIP PACK , Model No SMTH06O SMTH06P
ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.
- 2025-03-26FDA-DeviceClass IICYSTO , Model No SACY80R
ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.
- 2025-03-26FDA-DeviceClass IIURO ROBOTIC PACK , Model No LVUR44C LVUR44C-03
ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.
- 2025-03-26FDA-DeviceClass IILABOR & DELIVERY PPS , Model No LLLD64O LLLD64O-01 LLLD64O-02
ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.
- 2025-03-26FDA-DeviceClass IICENTRAL LINE PICC , Model No LLCL44H LLCL44H-01
ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.
- 2025-03-26FDA-DeviceClass IIC-SECTION PPS , Model No LLCI66M LLCI66M-02 LLCI66M-03 LLCI66M-04
ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.
- 2025-03-26FDA-DeviceClass IIBORN ON ARRIVAL KIT , Model No LLBN11B
ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.
- 2025-03-26FDA-DeviceClass IIGENERAL ANGIO PACK , Model Nos LLAP75G LLAP75G-01 LLAP75G-02 LLAP75G-03
ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.
- 2025-03-26FDA-DeviceClass IIOPEN HEART ADULT - SIDE A , Model Nos LLOH01I-01 LLOH01I
ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.
- 2025-03-26FDA-DeviceClass IILABOR & DELIVERY PACK, Model Nos LLLD19H
ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.
- 2025-03-26FDA-DeviceClass IILAPAROSCOPY PACK, Model Nos LLLA21J LLLA21J-02
ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.
- 2025-03-26FDA-DeviceClass IIC-SECTION PACK, Model Nos LLCS44F LLCS44F-01
ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.
- 2025-03-26FDA-DeviceClass IICYSTO PACK , Model N. HKCY31A
ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.
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