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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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26
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
November 1, 2023Medical DevicesFDA
American Contract Systems, Inc. recalls Pediatric Urology Wolson Pack, REF BPPU55A
Hazard: During an internal investigation, ACS identified that the components, I.V. Cath (part number 4252535-02) and Adhesive Dermabond (part number DHVM12) were inadvertently subjected to the ACS sterilization process and exposed to EO and higher temperatures than approved by the component manufacturer. As a result, the components may (1) have a loss/lack of functionality, (2) loss of drug efficacy, if applicable, and (3) have higher than specified EO residuals.
November 1, 2023Medical DevicesFDA
American Contract Systems, Inc. recalls Sub Q Recorder Pack, REF BPRC87A
Hazard: During an internal investigation, ACS identified that the components, I.V. Cath (part number 4252535-02) and Adhesive Dermabond (part number DHVM12) were inadvertently subjected to the ACS sterilization process and exposed to EO and higher temperatures than approved by the component manufacturer. As a result, the components may (1) have a loss/lack of functionality, (2) loss of drug efficacy, if applicable, and (3) have higher than specified EO residuals.
November 1, 2023Medical DevicesFDA
American Contract Systems, Inc. recalls Robotics Pack, REF SSRO22D
Hazard: During an internal investigation, ACS identified that the components, I.V. Cath (part number 4252535-02) and Adhesive Dermabond (part number DHVM12) were inadvertently subjected to the ACS sterilization process and exposed to EO and higher temperatures than approved by the component manufacturer. As a result, the components may (1) have a loss/lack of functionality, (2) loss of drug efficacy, if applicable, and (3) have higher than specified EO residuals.
November 1, 2023Medical DevicesFDA
American Contract Systems, Inc. recalls Robotics Pack, REF SJVO56B
Hazard: During an internal investigation, ACS identified that the components, I.V. Cath (part number 4252535-02) and Adhesive Dermabond (part number DHVM12) were inadvertently subjected to the ACS sterilization process and exposed to EO and higher temperatures than approved by the component manufacturer. As a result, the components may (1) have a loss/lack of functionality, (2) loss of drug efficacy, if applicable, and (3) have higher than specified EO residuals.
November 1, 2023Medical DevicesFDA
American Contract Systems, Inc. recalls Vasc. Open CVOR SJH, REF SJVO56B
Hazard: During an internal investigation, ACS identified that the components, I.V. Cath (part number 4252535-02) and Adhesive Dermabond (part number DHVM12) were inadvertently subjected to the ACS sterilization process and exposed to EO and higher temperatures than approved by the component manufacturer. As a result, the components may (1) have a loss/lack of functionality, (2) loss of drug efficacy, if applicable, and (3) have higher than specified EO residuals.
November 1, 2023Medical DevicesFDA
American Contract Systems, Inc. recalls Pediatric Heart SJH, REF SJPH34K
Hazard: During an internal investigation, ACS identified that the components, I.V. Cath (part number 4252535-02) and Adhesive Dermabond (part number DHVM12) were inadvertently subjected to the ACS sterilization process and exposed to EO and higher temperatures than approved by the component manufacturer. As a result, the components may (1) have a loss/lack of functionality, (2) loss of drug efficacy, if applicable, and (3) have higher than specified EO residuals.
November 1, 2023Medical DevicesFDA
American Contract Systems, Inc. recalls CVS PCSU SJH, REF SJCV48J
Hazard: During an internal investigation, ACS identified that the components, I.V. Cath (part number 4252535-02) and Adhesive Dermabond (part number DHVM12) were inadvertently subjected to the ACS sterilization process and exposed to EO and higher temperatures than approved by the component manufacturer. As a result, the components may (1) have a loss/lack of functionality, (2) loss of drug efficacy, if applicable, and (3) have higher than specified EO residuals.
November 1, 2023Medical DevicesFDA
American Contract Systems, Inc. recalls Robotics Pack SAH, REF SAR530M
Hazard: During an internal investigation, ACS identified that the components, I.V. Cath (part number 4252535-02) and Adhesive Dermabond (part number DHVM12) were inadvertently subjected to the ACS sterilization process and exposed to EO and higher temperatures than approved by the component manufacturer. As a result, the components may (1) have a loss/lack of functionality, (2) loss of drug efficacy, if applicable, and (3) have higher than specified EO residuals.
November 1, 2023Medical DevicesFDA
American Contract Systems, Inc. recalls Breast Plastics Pack, REF BBPL20D
Hazard: During an internal investigation, ACS identified that the components, I.V. Cath (part number 4252535-02) and Adhesive Dermabond (part number DHVM12) were inadvertently subjected to the ACS sterilization process and exposed to EO and higher temperatures than approved by the component manufacturer. As a result, the components may (1) have a loss/lack of functionality, (2) loss of drug efficacy, if applicable, and (3) have higher than specified EO residuals.
November 1, 2023Medical DevicesFDA
American Contract Systems, Inc. recalls LAVH, REF BBLV21C
Hazard: During an internal investigation, ACS identified that the components, I.V. Cath (part number 4252535-02) and Adhesive Dermabond (part number DHVM12) were inadvertently subjected to the ACS sterilization process and exposed to EO and higher temperatures than approved by the component manufacturer. As a result, the components may (1) have a loss/lack of functionality, (2) loss of drug efficacy, if applicable, and (3) have higher than specified EO residuals.
November 1, 2023Medical DevicesFDA
American Contract Systems, Inc. recalls General Pack, REF BBGP31C
Hazard: During an internal investigation, ACS identified that the components, I.V. Cath (part number 4252535-02) and Adhesive Dermabond (part number DHVM12) were inadvertently subjected to the ACS sterilization process and exposed to EO and higher temperatures than approved by the component manufacturer. As a result, the components may (1) have a loss/lack of functionality, (2) loss of drug efficacy, if applicable, and (3) have higher than specified EO residuals.
June 21, 2023Medical DevicesFDA
American Contract Systems, Inc. recalls Total Knee Pack, REF CETJ130, medical convenience kits
Hazard: Incorrect expiration date on product.
November 30, 2022Medical DevicesFDA
American Contract Systems, Inc. recalls BASIN SET, MEBS42K, general surgical kit
Hazard: Basin Set labeling error: components within the kit are for the Single Basin Set. Therefore, the contents of the package do not match the contents listed on the label.
October 19, 2022Medical DevicesFDA
American Contract Systems, Inc. recalls COVID Test Kit Nonsterile
Hazard: Kit incorrectly labeled for use with COVID testing and should not be used with any SARS-Co-V2 device.
September 14, 2022Medical DevicesFDA
American Contract Systems, Inc. recalls Various eye packs, cataract packs
Hazard: Product was exposed to multiple sterilization cycles without validation for multiple exposures.
September 14, 2022Medical DevicesFDA
American Contract Systems, Inc. recalls D&C pack
Hazard: Product was exposed to multiple sterilization cycles without validation for multiple exposures.
September 14, 2022Medical DevicesFDA
American Contract Systems, Inc. recalls Various C-section packs
Hazard: Product was exposed to multiple sterilization cycles without validation for multiple exposures.
September 14, 2022Medical DevicesFDA
American Contract Systems, Inc. recalls Various hysterectomy, vaginal packs
Hazard: Product was exposed to multiple sterilization cycles without validation for multiple exposures.
September 14, 2022Medical DevicesFDA
American Contract Systems, Inc. recalls Various ob/gyn packs
Hazard: Product was exposed to multiple sterilization cycles without validation for multiple exposures.
September 14, 2022Medical DevicesFDA
American Contract Systems, Inc. recalls Various neurology packs
Hazard: Product was exposed to multiple sterilization cycles without validation for multiple exposures.
September 14, 2022Medical DevicesFDA
American Contract Systems, Inc. recalls Various convenience packs
Hazard: Product was exposed to multiple sterilization cycles without validation for multiple exposures.
September 14, 2022Medical DevicesFDA
American Contract Systems, Inc. recalls Various convenience packs
Hazard: Product was exposed to multiple sterilization cycles without validation for multiple exposures.
September 14, 2022Medical DevicesFDA
American Contract Systems, Inc. recalls Breast Abdominoplasty Pack
Hazard: Product was exposed to multiple sterilization cycles without validation for multiple exposures.
September 14, 2022Medical DevicesFDA
American Contract Systems, Inc. recalls Various Port Insertion Packs
Hazard: Product was exposed to multiple sterilization cycles without validation for multiple exposures.
September 14, 2022Medical DevicesFDA
American Contract Systems, Inc. recalls Various Cysto Packs
Hazard: Product was exposed to multiple sterilization cycles without validation for multiple exposures.
September 14, 2022Medical DevicesFDA
American Contract Systems, Inc. recalls Various Laparoscopy Packs
Hazard: Product was exposed to multiple sterilization cycles without validation for multiple exposures.
September 14, 2022Medical DevicesFDA
American Contract Systems, Inc. recalls Various ENT Packs
Hazard: Product was exposed to multiple sterilization cycles without validation for multiple exposures.
September 14, 2022Medical DevicesFDA
American Contract Systems, Inc. recalls Various PICC Line, Central Line Packs
Hazard: Product was exposed to multiple sterilization cycles without validation for multiple exposures.
September 14, 2022Medical DevicesFDA
American Contract Systems, Inc. recalls Various Pacemaker Packs, Cardio Thoracic Packs
Hazard: Product was exposed to multiple sterilization cycles without validation for multiple exposures.
September 14, 2022Medical DevicesFDA
American Contract Systems, Inc. recalls Various Angiography/Cath Lab packs/trays
Hazard: Product was exposed to multiple sterilization cycles without validation for multiple exposures.