{"recall":{"id":"fda-device-99759","source":"FDA","sourceName":"U.S. Food and Drug Administration (openFDA device enforcement)","cat":"medicines","kids":false,"kind":"device","title":"American Contract Systems Inc recalls 3 products","firm":"American Contract Systems Inc","date":"2026-08-10","reported":"2026-10-07","status":"Ongoing","classification":"Class II","products":[{"name":"Medical convenience kits containing BD CliniClean Pericare Wipes within BD Urinary Catheter Trays ROBOTIC PACK - 242561 Model No. MHRB88AO","code":"UDI-DI 191072236531 Lots 42-8513411 42-8580011 42-8663211 42-8775711 42-8801311 42-8840611 42-8865911","quantity":"1,804 kits total","number":"Z-3292-2026","classification":"Class II"},{"name":"Medical convenience kits containing BD CliniClean Pericare Wipes within BD Urinary Catheter Trays CARDIAC HEART BUNDLE NS Model No. LMCH99P OPEN HEART 2 RCH¿ 0248495 Model No. RCOH62C","code":"LMCH99P UDI-DI 191072228147 Lots 42-8533511 42-8669111 42-8763811 42-8811311 42-8825411 42-8869411 RCOH62C UDI-DI 191072230942 Lots 42-8504411 42-8561511 42-8668211 42-8737811 42-8797911 42-8862511","quantity":"1,804 kits total","number":"Z-3293-2026","classification":"Class II"},{"name":"Medical convenience kits containing BD CliniClean Pericare Wipes within BD Urinary Catheter Trays ABDOMINAL HYSTERECTOMY - 205989 Model No. MHAH55AM LAVH-LAP COLON Model No. SPLL54U VAG HYST PACK Model No. SPVH62P","code":"MHAH55AM UDI-DI 191072236487 Lots 42-8529911 42-8649211 42-8687711 42-8797811 42-8857011 42-8869711 SPLL54U UDI-DI 191072239181 Lots 07-2516111 07-2528611 07-2545611 07-2547911 07-2561411 SPVH62P UDI-DI 191072238771 Lots 07-2544611 12-7436711","quantity":"1,804 kits total","number":"Z-3294-2026","classification":"Class II"}],"reason":"Kits contain manufacturer-recalled perineal care (pericare) wipes within urinary catheter trays, which may be contaminated with a lubricant used during the manufacturing process. Use of a contaminated wipe may lead to localized skin effects such as irritation, erythema, or mild inflammation. Failure to perform pericare due to disposal of contaminated wipes may increase risk of localized infection or catheter-associated urinary tract infection (CAUTI).","hazard":"FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).","affected":"US Nationwide distribution in the states of Iowa, Minnesota, Wisconsin, and South Dakota.","nationwide":true,"states":[],"units":"1,804 kits total; 1,804 kits total; 1,804 kits total","remedy":"","whatToDo":"Check your product against the names and codes above. The FDA enforcement record lists the recall as voluntary: firm initiated; it does not state a consumer remedy, so follow the firm’s notice or the FDA link.","contact":"","url":"https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99759","apiUrl":"https://api.fda.gov/device/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","rawHash":"7918c5791b6dc68d","firstSeen":"2026-11-02T13:57:14.206Z","updatedAt":"2026-11-02T13:57:14.206Z","history":[]},"official":{"fetchedAt":"2026-11-02T13:57:14.206Z","apiUrl":"https://api.fda.gov/device/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","officialUrl":"https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99759","record":[{"status":"Ongoing","city":"Tiffin","state":"OH","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99759","recalling_firm":"American Contract Systems Inc","address_1":"85 Shaffer Park Dr","address_2":"","postal_code":"44883-9290","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"US Nationwide distribution in the states of Iowa, Minnesota, Wisconsin, and South Dakota.","recall_number":"Z-3292-2026","product_description":"Medical convenience kits containing BD CliniClean Pericare Wipes within BD Urinary Catheter Trays    ROBOTIC PACK - 242561  Model No. MHRB88AO","product_quantity":"1,804 kits total","reason_for_recall":"Kits contain manufacturer-recalled perineal care (pericare) wipes within urinary catheter trays, which may be contaminated with a lubricant used during the manufacturing process. Use of a contaminated wipe may lead to localized skin effects such as irritation, erythema, or mild inflammation. Failure to perform pericare due to disposal of contaminated wipes may increase risk of localized infection or catheter-associated urinary tract infection (CAUTI).","recall_initiation_date":"20260810","center_classification_date":"20260925","report_date":"20261007","code_info":"UDI-DI 191072236531   Lots 42-8513411  42-8580011  42-8663211  42-8775711  42-8801311  42-8840611  42-8865911","more_code_info":""},{"status":"Ongoing","city":"Tiffin","state":"OH","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99759","recalling_firm":"American Contract Systems Inc","address_1":"85 Shaffer Park Dr","address_2":"","postal_code":"44883-9290","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"US Nationwide distribution in the states of Iowa, Minnesota, Wisconsin, and South Dakota.","recall_number":"Z-3293-2026","product_description":"Medical convenience kits containing BD CliniClean Pericare Wipes within BD Urinary Catheter Trays    CARDIAC HEART BUNDLE NS\t  \tModel No. LMCH99P    OPEN HEART 2 RCH¿ 0248495\t  \tModel No. RCOH62C","product_quantity":"1,804 kits total","reason_for_recall":"Kits contain manufacturer-recalled perineal care (pericare) wipes within urinary catheter trays, which may be contaminated with a lubricant used during the manufacturing process. Use of a contaminated wipe may lead to localized skin effects such as irritation, erythema, or mild inflammation. Failure to perform pericare due to disposal of contaminated wipes may increase risk of localized infection or catheter-associated urinary tract infection (CAUTI).","recall_initiation_date":"20260810","center_classification_date":"20260925","report_date":"20261007","code_info":"LMCH99P    UDI-DI 191072228147    Lots 42-8533511   42-8669111   42-8763811   42-8811311   42-8825411   42-8869411    RCOH62C    UDI-DI 191072230942    Lots 42-8504411   42-8561511   42-8668211   42-8737811   42-8797911   42-8862511","more_code_info":""},{"status":"Ongoing","city":"Tiffin","state":"OH","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99759","recalling_firm":"American Contract Systems Inc","address_1":"85 Shaffer Park Dr","address_2":"","postal_code":"44883-9290","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"US Nationwide distribution in the states of Iowa, Minnesota, Wisconsin, and South Dakota.","recall_number":"Z-3294-2026","product_description":"Medical convenience kits containing BD CliniClean Pericare Wipes within BD Urinary Catheter Trays    ABDOMINAL HYSTERECTOMY - 205989\t  \tModel No. MHAH55AM  \t  LAVH-LAP COLON\t  \tModel No. SPLL54U  \t  VAG HYST PACK\t  \tModel No. SPVH62P","product_quantity":"1,804 kits total","reason_for_recall":"Kits contain manufacturer-recalled perineal care (pericare) wipes within urinary catheter trays, which may be contaminated with a lubricant used during the manufacturing process. Use of a contaminated wipe may lead to localized skin effects such as irritation, erythema, or mild inflammation. Failure to perform pericare due to disposal of contaminated wipes may increase risk of localized infection or catheter-associated urinary tract infection (CAUTI).","recall_initiation_date":"20260810","center_classification_date":"20260925","report_date":"20261007","code_info":"MHAH55AM    UDI-DI 191072236487    Lots 42-8529911   42-8649211   42-8687711   42-8797811   42-8857011   42-8869711    SPLL54U    UDI-DI 191072239181    Lots 07-2516111   07-2528611   07-2545611   07-2547911   07-2561411    SPVH62P    UDI-DI 191072238771    Lots 07-2544611   12-7436711","more_code_info":""}]}}