American Contract Systems Inc
161 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.
- 2025-03-26FDA-DeviceClass IIMAJOR DIEP, Model Nos. CCMJ73G-01 CCMJ73H
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 IIHIP SCOPE, Model Nos. CCHS21B CCHS21B-01 CCHS21B-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 IIDR DIULUS INJECTION PACK, Model Nos. CCDU12C CCDU12D CCDU12D-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 IILAPAROSCOPY PACK, Model No. CALS41F, CALS41F-01, CALS41G
ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.
- 2024-10-02FDA-DeviceClass IIPacemaker, COPM11B; Medical convenience kit
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.
- 2024-10-02FDA-DeviceClass IICysto, FTCY03L; Medical convenience kit
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.
- 2024-10-02FDA-DeviceClass IINasal Sinus Pack, MTSN26B; Medical convenience kit
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.
- 2024-10-02FDA-DeviceClass IIENT, COEN27N; Medical convenience kit
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.
- 2024-10-02FDA-DeviceClass IIEssentia MAJ Laparotomy Std Pack, ESLT53B; Medical convenience kit
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.
- 2024-10-02FDA-DeviceClass IICath Lab Pack, CECL02P; Medical convenience kit
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.
- 2024-10-02FDA-DeviceClass IIVaginal Delivery, ASDV25B; Medical convenience kit
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.
- 2024-10-02FDA-DeviceClass IIHand Pack, AKHD97C; Medical convenience kit
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.
- 2024-10-02FDA-DeviceClass IINeuro Vascular, ANKV91A; Medical convenience kit
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.
- 2024-10-02FDA-DeviceClass IIIR Procedure Pack, CEAT19W; Medical convenience kit
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.
- 2024-10-02FDA-DeviceClass IIParacentesis Thoracente, SLPT76H; Medical convenience kit
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.
- 2024-10-02FDA-DeviceClass IIBilateral Tubal Ligation Pack, FHBT3T; Medical convenience kit
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.
- 2024-10-02FDA-DeviceClass IIShoulder, SESH18I; Medical convenience kit
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.
- 2024-10-02FDA-DeviceClass IIDay Surgery General Pack, FHGE18T; Medical convenience kit
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.
- 2024-10-02FDA-DeviceClass IIOpen Shoulder, LWOS39L; Medical convenience kit
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.
- 2024-10-02FDA-DeviceClass IIArthroscopy Pack, MSKA45A; Medical convenience kit
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.
- 2024-10-02FDA-DeviceClass IIEndovascular AAA Pack, ESED52B; Medical convenience kit
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.
- 2024-10-02FDA-DeviceClass IIEndovascular AAA Pack, ESED52B; Medical convenience kit
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.
- 2024-10-02FDA-DeviceClass IIPACEMAKER PACK, SLCV01J; Medical convenience kit
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.
- 2024-08-14FDA-DeviceClass IIAmerican Contract Systems Spine Pack convenience kit
Product released with insufficient aeration time impacting the kits sterilized on the same cycle or in the same aeration chamber
- 2024-08-14FDA-DeviceClass IIAmerican Contract Systems Biopsy Drape Pack convenience kit
Product released with insufficient aeration time impacting the kits sterilized on the same cycle or in the same aeration chamber, which may have been compromised in sterility
- 2024-08-14FDA-DeviceClass IIAmerican Contract Systems Cataract Pack convenience kit
Product released with insufficient aeration time impacting the kits sterilized on the same cycle or in the same aeration chamber
- 2024-08-14FDA-DeviceClass IIAmerican Contract Systems Extremity convenience kit, American Contract Systems Hand Pack convenience kit, and American Contract Systems Total Knee Pack convenience kit
Product released with insufficient aeration time impacting the kits sterilized on the same cycle or in the same aeration chamber, which may have been compromised in sterility
- 2024-08-14FDA-DeviceClass IIAmerican Contract Systems Special Procedure Pack convenience kit
Product released with insufficient aeration time impacting the kits sterilized on the same cycle or in the same aeration chamber, which may have been compromised in sterility
- 2024-08-14FDA-DeviceClass IIAmerican Contract Systems Laparoscopy Litho Std Pack convenience kit and American Contract Systems Lap Chole convenience kit
Product released with insufficient aeration time impacting the kits sterilized on the same cycle or in the same aeration chamber, which may have been compromised in sterility
- 2024-08-14FDA-DeviceClass IIAmerican Contract Systems Gyn Laparoscopy convenience kit
Product released with insufficient aeration time impacting the kits sterilized on the same cycle or in the same aeration chamber, which may have been compromised in sterility
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