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American Contract Systems Recalls
204 recalls on record · November 21, 2018 to May 13, 2026 · Medical Devices
Recalls by year
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Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
March 26, 2025Medical DevicesFDA
American Contract Systems Inc recalls CYSTO PACK , Model N. HKCY31A
Hazard: ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.
March 26, 2025Medical DevicesFDA
American Contract Systems Inc recalls MAJOR DIEP, Model Nos. CCMJ73G-01 CCMJ73H
Hazard: ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.
March 26, 2025Medical DevicesFDA
American Contract Systems Inc recalls HIP SCOPE, Model Nos. CCHS21B CCHS21B-01 CCHS21B-02
Hazard: ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.
March 26, 2025Medical DevicesFDA
American Contract Systems Inc recalls DR DIULUS INJECTION PACK, Model Nos. CCDU12C CCDU12D CCDU12D-01
Hazard: ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.
March 26, 2025Medical DevicesFDA
American Contract Systems Inc recalls LAPAROSCOPY PACK, Model No. CALS41F, CALS41F-01, CALS41G
Hazard: ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.
October 2, 2024Medical DevicesFDA
American Contract Systems, Inc. recalls Pacemaker, COPM11B; Medical convenience kit
Hazard: 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.
October 2, 2024Medical DevicesFDA
American Contract Systems, Inc. recalls Cysto, FTCY03L; Medical convenience kit
Hazard: 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.
October 2, 2024Medical DevicesFDA
American Contract Systems, Inc. recalls Nasal Sinus Pack, MTSN26B; Medical convenience kit
Hazard: 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.
October 2, 2024Medical DevicesFDA
American Contract Systems, Inc. recalls ENT, COEN27N; Medical convenience kit
Hazard: 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.
October 2, 2024Medical DevicesFDA
American Contract Systems, Inc. recalls Essentia MAJ Laparotomy Std Pack, ESLT53B; Medical convenience kit
Hazard: 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.
October 2, 2024Medical DevicesFDA
American Contract Systems, Inc. recalls Cath Lab Pack, CECL02P; Medical convenience kit
Hazard: 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.
October 2, 2024Medical DevicesFDA
American Contract Systems, Inc. recalls Vaginal Delivery, ASDV25B; Medical convenience kit
Hazard: 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.
October 2, 2024Medical DevicesFDA
American Contract Systems, Inc. recalls Hand Pack, AKHD97C; Medical convenience kit
Hazard: 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.
October 2, 2024Medical DevicesFDA
American Contract Systems, Inc. recalls Neuro Vascular, ANKV91A; Medical convenience kit
Hazard: 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.
October 2, 2024Medical DevicesFDA
American Contract Systems, Inc. recalls IR Procedure Pack, CEAT19W; Medical convenience kit
Hazard: 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.
October 2, 2024Medical DevicesFDA
American Contract Systems, Inc. recalls Paracentesis Thoracente, SLPT76H; Medical convenience kit
Hazard: 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.
October 2, 2024Medical DevicesFDA
American Contract Systems, Inc. recalls Bilateral Tubal Ligation Pack, FHBT3T; Medical convenience kit
Hazard: 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.
October 2, 2024Medical DevicesFDA
American Contract Systems, Inc. recalls Shoulder, SESH18I; Medical convenience kit
Hazard: 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.
October 2, 2024Medical DevicesFDA
American Contract Systems, Inc. recalls Day Surgery General Pack, FHGE18T; Medical convenience kit
Hazard: 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.
October 2, 2024Medical DevicesFDA
American Contract Systems, Inc. recalls Open Shoulder, LWOS39L; Medical convenience kit
Hazard: 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.
October 2, 2024Medical DevicesFDA
American Contract Systems, Inc. recalls Arthroscopy Pack, MSKA45A; Medical convenience kit
Hazard: 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.
October 2, 2024Medical DevicesFDA
American Contract Systems, Inc. recalls Endovascular AAA Pack, ESED52B; Medical convenience kit
Hazard: 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.
October 2, 2024Medical DevicesFDA
American Contract Systems, Inc. recalls Endovascular AAA Pack, ESED52B; Medical convenience kit
Hazard: 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.
October 2, 2024Medical DevicesFDA
American Contract Systems, Inc. recalls PACEMAKER PACK, SLCV01J; Medical convenience kit
Hazard: 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.
August 14, 2024Medical DevicesFDA
American Contract Systems, Inc. recalls American Contract Systems Spine Pack convenience kit
Hazard: Product released with insufficient aeration time impacting the kits sterilized on the same cycle or in the same aeration chamber
August 14, 2024Medical DevicesFDA
American Contract Systems, Inc. recalls American Contract Systems Biopsy Drape Pack convenience kit
Hazard: 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
August 14, 2024Medical DevicesFDA
American Contract Systems, Inc. recalls American Contract Systems Cataract Pack convenience kit
Hazard: Product released with insufficient aeration time impacting the kits sterilized on the same cycle or in the same aeration chamber
August 14, 2024Medical DevicesFDA
American Contract Systems, Inc. recalls American Contract Systems Extremity convenience kit, American Contract Systems Hand Pack convenience kit, and American C
Hazard: 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
August 14, 2024Medical DevicesFDA
American Contract Systems, Inc. recalls American Contract Systems Special Procedure Pack convenience kit
Hazard: 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
August 14, 2024Medical DevicesFDA
American Contract Systems, Inc. recalls American Contract Systems Laparoscopy Litho Std Pack convenience kit and American Contract Systems Lap Chole convenience
Hazard: 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