{"recall":{"id":"fda-device-99514","source":"FDA","sourceName":"U.S. Food and Drug Administration (openFDA device enforcement)","cat":"medicines","kids":false,"kind":"device","title":"American Contract Systems Inc recalls 4 products","firm":"American Contract Systems Inc","date":"2026-06-29","reported":"2026-09-02","status":"Ongoing","classification":"Class II","products":[{"name":"American Contract System Convenience Kit, CV B PACK, Model/Catalog Number: TNCB10AM","code":"Lot Code: Lot Number: 42-8493811 UDI: 191072232991 Expiration Date: 7/15/2026","quantity":"30 units","number":"Z-3000-2026","classification":"Class II"},{"name":"American Contract System Convenience Kit, CV B PACK, Model/Catalog Number: TNCB10AN","code":"Lot Code: Lot Number: 42-8768511 UDI: 191072239907 Expiration Date: 1/6/2027","quantity":"30 units","number":"Z-3001-2026","classification":"Class II"},{"name":"American Contract System Convenience Kits, CV B PACK, Model/Catalog Number: TNCB10AP","code":"Lot Code: Lot Number: 42-8808611 UDI: 191072241252 Expiration Date: 1/6/2027","quantity":"30 units","number":"Z-3002-2026","classification":"Class II"},{"name":"American Contract System Convenience Kit, D & C PACK, Model/Catalog Number: LLPD90H","code":"Lot Code: Lot Number: 70-054952 UDI: 191072219947","quantity":"12 units","number":"Z-3003-2026","classification":"Class II"}],"reason":"The Convenience Kits contain Medline s Red Rubber Intermittent Catheters (8Fr-22 Fr) and Red Rubber Intermittent Catheter Trays. Medline Industries, LP has identified representative samples did not meet applicable performance specifications. The Convenience Kits contain Medline's Red Rubber Intermittent Catheters (8Fr-22 Fr) and Red Rubber Intermittent Catheter Trays. Medline Industries, LP has identified representative samples did not meet applicable performance specifications.","hazard":"FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).","affected":"US Nationwide distribution in the states of IA, OH.","nationwide":true,"states":[],"units":"30 units; 30 units; 30 units; 12 units","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=99514","apiUrl":"https://api.fda.gov/device/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","rawHash":"555ddb8a9620bf68","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=99514","record":[{"status":"Ongoing","city":"Tiffin","state":"OH","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99514","recalling_firm":"American Contract Systems Inc","address_1":"85 Shaffer Park Dr","address_2":"N/A","postal_code":"44883-9290","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"US Nationwide distribution in the states of IA, OH.","recall_number":"Z-3000-2026","product_description":"American Contract System Convenience Kit, CV B PACK, Model/Catalog Number: TNCB10AM","product_quantity":"30 units","reason_for_recall":"The Convenience Kits contain Medline s Red Rubber Intermittent Catheters (8Fr-22 Fr) and Red Rubber Intermittent Catheter Trays. Medline Industries, LP has identified representative samples did not meet applicable performance specifications.","recall_initiation_date":"20260629","center_classification_date":"20260821","report_date":"20260902","code_info":"Lot Code: Lot Number: 42-8493811 UDI: 191072232991 Expiration Date: 7/15/2026"},{"status":"Ongoing","city":"Tiffin","state":"OH","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99514","recalling_firm":"American Contract Systems Inc","address_1":"85 Shaffer Park Dr","address_2":"N/A","postal_code":"44883-9290","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"US Nationwide distribution in the states of IA, OH.","recall_number":"Z-3001-2026","product_description":"American Contract System Convenience Kit, CV B PACK, Model/Catalog Number: TNCB10AN","product_quantity":"30 units","reason_for_recall":"The Convenience Kits contain Medline s Red Rubber Intermittent Catheters (8Fr-22 Fr) and Red Rubber Intermittent Catheter Trays. Medline Industries, LP has identified representative samples did not meet applicable performance specifications.","recall_initiation_date":"20260629","center_classification_date":"20260821","report_date":"20260902","code_info":"Lot Code: Lot Number: 42-8768511 UDI: 191072239907 Expiration Date: 1/6/2027"},{"status":"Ongoing","city":"Tiffin","state":"OH","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99514","recalling_firm":"American Contract Systems Inc","address_1":"85 Shaffer Park Dr","address_2":"N/A","postal_code":"44883-9290","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"US Nationwide distribution in the states of IA, OH.","recall_number":"Z-3002-2026","product_description":"American Contract System Convenience Kits, CV B PACK, Model/Catalog Number: TNCB10AP","product_quantity":"30 units","reason_for_recall":"The Convenience Kits contain Medline s Red Rubber Intermittent Catheters (8Fr-22 Fr) and Red Rubber Intermittent Catheter Trays. Medline Industries, LP has identified representative samples did not meet applicable performance specifications.","recall_initiation_date":"20260629","center_classification_date":"20260821","report_date":"20260902","code_info":"Lot Code: Lot Number: 42-8808611 UDI: 191072241252 Expiration Date: 1/6/2027"},{"status":"Ongoing","city":"Tiffin","state":"OH","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99514","recalling_firm":"American Contract Systems Inc","address_1":"85 Shaffer Park Dr","address_2":"N/A","postal_code":"44883-9290","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"US Nationwide distribution in the states of IA, OH.","recall_number":"Z-3003-2026","product_description":"American Contract System Convenience Kit, D & C PACK, Model/Catalog Number: LLPD90H","product_quantity":"12 units","reason_for_recall":"The Convenience Kits contain Medline's Red Rubber Intermittent Catheters (8Fr-22 Fr) and Red Rubber Intermittent Catheter Trays. Medline Industries, LP has identified representative samples did not meet applicable performance specifications.","recall_initiation_date":"20260629","center_classification_date":"20260821","report_date":"20260902","code_info":"Lot Code: Lot Number: 70-054952 UDI: 191072219947"}]}}