{"recall":{"id":"fda-device-99482","source":"FDA","sourceName":"U.S. Food and Drug Administration (openFDA device enforcement)","cat":"medicines","kids":false,"kind":"device","title":"American Contract Systems Inc recalls 2 products","firm":"American Contract Systems Inc","date":"2026-05-19","reported":"2026-08-26","status":"Ongoing","classification":"Class II","products":[{"name":"American Contract Systems medical procedure kits and trays labeled as: 1) CRANI PACK - 208400, Model Item Number UDCP57AI; 2) SPINE PACK, Model Item Number HSLM53AC; 3) CRANIAL PACK - 205992, Model Item Number MHCP75AH; 4) IMRI CRANI PACK - 213871, Model Item Number ANCI17AO; 5) CRANI PACK - 205942, Model Item Number ANCP30AP; 6) A-P PACK - 205936, Model Item Number ANAP22AP; 7) POSTERIOR PACK - 205960, Model Item Number ANPP15AR; 8) ANTERIOR CERVICAL PACK - 205935, Model Item Number ANAN51AI; 9) LAMINECTOMY PACK - 205957, Model Item Number ANLM40AG.","code":"Model/Item Number UDCP57AI, UDI/DI 191072216250, Lot Number 42-8388111; Model/Item Number UDCP57AI, UDI/DI 191072216250, Lot Number 42-8474311; Model/Item Number UDCP57AI, UDI/DI 191072216250, Lot Number 42-8521711; Model/Item Number UDCP57AI, UDI/DI 191072216250, Lot Number 42-8547611; Model/Item Number UDCP57AI, UDI/DI 191072216250, Lot Number 42-8672411; Model/Item Number UDCP57AI, UDI/DI 191072216250, Lot Number 42-8775211; Model/Item Number UDCP57AI, UDI/DI 191072216250, Lot Number 42-8810511; Model/Item Number HSLM53AC, UDI/DI 191072238207, Lot Number 42-8447111; Model/Item Number HSLM53AC, UDI/DI 191072238207, Lot Number 42-8548311; Model/Item Number HSLM53AC, UDI/DI 191072238207, Lot Number 42-8630311; Model/Item Number HSLM53AC, UDI/DI 191072238207, Lot Number 42-8785011; Model/Item Number HSLM53AC, UDI/DI 191072238207, Lot Number 42-8742911; Model/Item Number MHCP75AH, UDI/DI 191072211934, Lot Number 42-8455911; Model/Item Number MHCP75AH, UDI/DI 191072211934, Lot Number 42-8498111; Model/Item Number MHCP75AH, UDI/DI 191072211934, Lot Number 42-8538111; Model/Item Number MHCP75AH, UDI/DI 191072211934, Lot Number 42-8601211; Model/Item Number MHCP75AH, UDI/DI 191072211934, Lot Number 42-8764511; Model/Item Number MHCP75AH, UDI/DI 191072211934, Lot Number 42-8823811; Model/Item Number ANCI17AO, UDI/DI 191072232052, Lot Number 42-8384311; Model/Item Number ANCI17AO, UDI/DI 191072232052, Lot Number 42-8525011; Model/Item Number ANCI17AO, UDI/DI 191072232052, Lot Number 42-8611711; Model/Item Number ANCI17AO, UDI/DI 191072232052, Lot Number 42-8705911; Model/Item Number ANCI17AO, UDI/DI 191072232052, Lot Number 42-8798411; Model/Item Number ANCI17AO, UDI/DI 191072232052, Lot Number 42-8831911; Model/Item Number ANCI17AO, UDI/DI 191072232052, Lot Number 42-8854511; Model/Item Number ANCP30AP, UDI/DI 191072232069, Lot Number 42-8497911; Model/Item Number ANCP30AP, UDI/DI 191072232069, Lot Number 42-8537311; Model/Item Number ANCP30AP, UDI/DI 191072232069, Lot Number 42-8673211; Model/Item Number ANCP30AP, UDI/DI 191072232069, Lot Number 42-8756411; Model/Item Number ANCP30AP, UDI/DI 191072232069, Lot Number 42-8818611; Model/Item Number ANCP30AP, UDI/DI 191072232069, Lot Number 42-8854011; Model/Item Number ANCP30AP, UDI/DI 191072232069, Lot Number 42-8869111; Model/Item Number ANAP22AP, UDI/DI 191072214287, Lot Number 42-8497811; Model/Item Number ANAP22AP, UDI/DI 191072214287, Lot Number 42-8588811; Model/Item Number ANAP22AP, UDI/DI 191072214287, Lot Number 42-8666611; Model/Item Number ANAP22AP, UDI/DI 191072214287, Lot Number 42-8730411; Model/Item Number ANAP22AP, UDI/DI 191072214287, Lot Number 42-8785411; Model/Item Number ANAP22AP, UDI/DI 191072214287, Lot Number 42-8833011; Model/Item Number ANAP22AP, UDI/DI 191072214287, Lot Number 42-8854611; Model/Item Number ANAP22AP, UDI/DI 191072214287, Lot Number 42-8869611; Model/Item Number ANPP15AR, UDI/DI 191072214423, Lot Number 42-8345311; Model/Item Number ANPP15AR, UDI/DI 191072214423, Lot Number 42-8379411; Model/Item Number ANPP15AR, UDI/DI 191072214423, Lot Number 42-8547011; Model/Item Number ANPP15AR, UDI/DI 191072214423, Lot Number 42-8654511; Model/Item Number ANPP15AR, UDI/DI 191072214423, Lot Number 42-8746311; Model/Item Number ANPP15AR, UDI/DI 191072214423, Lot Number 42-8801611; Model/Item Number ANAN51AI, UDI/DI 191072232045, Lot Number 42-8401611; Model/Item Number ANAN51AI, UDI/DI 191072232045, Lot Number 42-8611411; Model/Item Number ANAN51AI, UDI/DI 191072232045, Lot Number 42-8611411A; Model/Item Number ANAN51AI, UDI/DI 191072232045, Lot Number 42-8648311; Model/Item Number ANAN51AI, UDI/DI 191072232045, Lot Number 42-8755811; Model/Item Number ANAN51AI, UDI/DI 191072232045, Lot Number 42-8807911; Model/Item Number ANAN51AI, UDI/DI 191072232045, Lot Number 42-8852311; Model/Item Number ANAN51AI, UDI/DI 191072232045, Lot Number 42-8869511; Model/Item Number ANLM40AG, UDI/DI 191072232076, Lot Number 42-8384511; Model/Item Number ANLM40AG, UDI/DI 191072232076, Lot Number 42-8545711; Model/Item Number ANLM40AG, UDI/DI 191072232076, Lot Number 42-8634611; Model/Item Number ANLM40AG, UDI/DI 191072232076, Lot Number 42-8707111; Model/Item Number ANLM40AG, UDI/DI 191072232076, Lot Number 42-8789211; Model/Item Number ANLM40AG, UDI/DI 191072232076, Lot Number 42-8831811; Model/Item Number ANLM40AG, UDI/DI 191072232076, Lot Number 42-8853011; Model/Item Number ANLM40AG, UDI/DI 191072232076, Lot Number 42-8868811.","quantity":"4789 kits","number":"Z-2989-2026","classification":"Class II"},{"name":"American Contract Systems medical procedure kits and trays labeled as: 1) ANTERIOR CERVICAL PACK - 205988, Model Item Number MHAC65AH; 2) SPINE PACK - 206013, Model Item Number MHSP99AF.","code":"Model/Item Number MHAC65AH, UDI/DI 191072211910, Lot Number 42-8606211; Model/Item Number MHAC65AH, UDI/DI 191072211910, Lot Number 42-8687611; Model/Item Number MHAC65AH, UDI/DI 191072211910, Lot Number 42-8847511; Model/Item Number MHSP99AF, UDI/DI 191072214782, Lot Number 42-8423411; Model/Item Number MHSP99AF, UDI/DI 191072214782, Lot Number 42-8470411; Model/Item Number MHSP99AF, UDI/DI 191072214782, Lot Number 42-8527611; Model/Item Number MHSP99AF, UDI/DI 191072214782, Lot Number 42-8601311; Model/Item Number MHSP99AF, UDI/DI 191072214782, Lot Number 42-8731511; Model/Item Number MHSP99AF, UDI/DI 191072214782, Lot Number 42-8795311.","quantity":"160 kits","number":"Z-2990-2026","classification":"Class II"}],"reason":"The recall notice was initiated due to a Medicom Urgent Medical Device Recall. Medicom is recalling specific lots of Ritmed¿ Neurological Sponges Non-Sterile Models 55992C to 55998C due to potential for unexpected variability of endotoxin levels on the products.","hazard":"FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).","affected":"US distribution to states of:  MN, MO, IA","nationwide":false,"states":["IA","MN","MO"],"units":"4789 kits; 160 kits","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=99482","apiUrl":"https://api.fda.gov/device/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","rawHash":"54b553114b9d7fdd","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=99482","record":[{"status":"Ongoing","city":"Tiffin","state":"OH","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99482","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":"E-Mail","distribution_pattern":"US distribution to states of:  MN, MO, IA","recall_number":"Z-2989-2026","product_description":"American Contract Systems medical procedure kits and trays labeled as:    1) CRANI PACK - 208400, Model Item Number UDCP57AI;   2) SPINE PACK, Model Item Number HSLM53AC;   3) CRANIAL PACK - 205992, Model Item Number MHCP75AH;   4) IMRI CRANI PACK - 213871, Model Item Number ANCI17AO;   5) CRANI PACK - 205942, Model Item Number ANCP30AP;   6) A-P PACK - 205936, Model Item Number ANAP22AP;   7) POSTERIOR PACK - 205960, Model Item Number ANPP15AR;   8) ANTERIOR CERVICAL PACK - 205935, Model Item Number ANAN51AI;   9) LAMINECTOMY PACK - 205957, Model Item Number ANLM40AG.","product_quantity":"4789 kits","reason_for_recall":"The recall notice was initiated due to a Medicom Urgent Medical Device Recall. Medicom is recalling specific lots of Ritmed¿ Neurological Sponges Non-Sterile Models 55992C to 55998C due to potential for unexpected variability of endotoxin levels on the products.","recall_initiation_date":"20260519","center_classification_date":"20260820","report_date":"20260826","code_info":"Model/Item Number UDCP57AI, UDI/DI 191072216250, Lot Number 42-8388111;  Model/Item Number UDCP57AI, UDI/DI 191072216250, Lot Number 42-8474311;  Model/Item Number UDCP57AI, UDI/DI 191072216250, Lot Number 42-8521711;  Model/Item Number UDCP57AI, UDI/DI 191072216250, Lot Number 42-8547611;  Model/Item Number UDCP57AI, UDI/DI 191072216250, Lot Number 42-8672411;  Model/Item Number UDCP57AI, UDI/DI 191072216250, Lot Number 42-8775211;  Model/Item Number UDCP57AI, UDI/DI 191072216250, Lot Number 42-8810511;  Model/Item Number HSLM53AC, UDI/DI 191072238207, Lot Number 42-8447111;  Model/Item Number HSLM53AC, UDI/DI 191072238207, Lot Number 42-8548311;  Model/Item Number HSLM53AC, UDI/DI 191072238207, Lot Number 42-8630311;  Model/Item Number HSLM53AC, UDI/DI 191072238207, Lot Number 42-8785011;  Model/Item Number HSLM53AC, UDI/DI 191072238207, Lot Number 42-8742911;  Model/Item Number MHCP75AH, UDI/DI 191072211934, Lot Number 42-8455911;  Model/Item Number MHCP75AH, UDI/DI 191072211934, Lot Number 42-8498111;  Model/Item Number MHCP75AH, UDI/DI 191072211934, Lot Number 42-8538111;  Model/Item Number MHCP75AH, UDI/DI 191072211934, Lot Number 42-8601211;  Model/Item Number MHCP75AH, UDI/DI 191072211934, Lot Number 42-8764511;  Model/Item Number MHCP75AH, UDI/DI 191072211934, Lot Number 42-8823811;  Model/Item Number ANCI17AO, UDI/DI 191072232052, Lot Number 42-8384311;  Model/Item Number ANCI17AO, UDI/DI 191072232052, Lot Number 42-8525011;  Model/Item Number ANCI17AO, UDI/DI 191072232052, Lot Number 42-8611711;  Model/Item Number ANCI17AO, UDI/DI 191072232052, Lot Number 42-8705911;  Model/Item Number ANCI17AO, UDI/DI 191072232052, Lot Number 42-8798411;  Model/Item Number ANCI17AO, UDI/DI 191072232052, Lot Number 42-8831911;  Model/Item Number ANCI17AO, UDI/DI 191072232052, Lot Number 42-8854511;  Model/Item Number ANCP30AP, UDI/DI 191072232069, Lot Number 42-8497911;  Model/Item Number ANCP30AP, UDI/DI 191072232069, Lot Number 42-8537311;  Model/Item Number ANCP30AP, UDI/DI 191072232069, Lot Number 42-8673211;  Model/Item Number ANCP30AP, UDI/DI 191072232069, Lot Number 42-8756411;  Model/Item Number ANCP30AP, UDI/DI 191072232069, Lot Number 42-8818611;  Model/Item Number ANCP30AP, UDI/DI 191072232069, Lot Number 42-8854011;  Model/Item Number ANCP30AP, UDI/DI 191072232069, Lot Number 42-8869111;  Model/Item Number ANAP22AP, UDI/DI 191072214287, Lot Number 42-8497811;  Model/Item Number ANAP22AP, UDI/DI 191072214287, Lot Number 42-8588811;  Model/Item Number ANAP22AP, UDI/DI 191072214287, Lot Number 42-8666611;  Model/Item Number ANAP22AP, UDI/DI 191072214287, Lot Number 42-8730411;  Model/Item Number ANAP22AP, UDI/DI 191072214287, Lot Number 42-8785411;  Model/Item Number ANAP22AP, UDI/DI 191072214287, Lot Number 42-8833011;  Model/Item Number ANAP22AP, UDI/DI 191072214287, Lot Number 42-8854611;  Model/Item Number ANAP22AP, UDI/DI 191072214287, Lot Number 42-8869611;  Model/Item Number ANPP15AR, UDI/DI 191072214423, Lot Number 42-8345311;  Model/Item Number ANPP15AR, UDI/DI 191072214423, Lot Number 42-8379411;  Model/Item Number ANPP15AR, UDI/DI 191072214423, Lot Number 42-8547011;  Model/Item Number ANPP15AR, UDI/DI 191072214423, Lot Number 42-8654511;  Model/Item Number ANPP15AR, UDI/DI 191072214423, Lot Number 42-8746311;  Model/Item Number ANPP15AR, UDI/DI 191072214423, Lot Number 42-8801611;  Model/Item Number ANAN51AI, UDI/DI 191072232045, Lot Number 42-8401611;  Model/Item Number ANAN51AI, UDI/DI 191072232045, Lot Number 42-8611411;  Model/Item Number ANAN51AI, UDI/DI 191072232045, Lot Number 42-8611411A;  Model/Item Number ANAN51AI, UDI/DI 191072232045, Lot Number 42-8648311;  Model/Item Number ANAN51AI, UDI/DI 191072232045, Lot Number 42-8755811;  Model/Item Number ANAN51AI, UDI/DI 191072232045, Lot Number 42-8807911;  Model/Item Number ANAN51AI, UDI/DI 191072232045, Lot Number 42-8852311;  Model/Item Number ANAN51AI, UDI/DI 191072232045, Lot Number 42-8869511;  Model/Item Number ANLM40AG, UDI/DI 191072232076, Lot Number 42-8384511;  Model/Item Number ANLM40AG, UDI/DI 191072232076, Lot Number 42-8545711;  Model/Item Number ANLM40AG, UDI/DI 191072232076, Lot Number 42-8634611;  Model/Item Number ANLM40AG, UDI/DI 191072232076, Lot Number 42-8707111;  Model/Item Number ANLM40AG, UDI/DI 191072232076, Lot Number 42-8789211;  Model/Item Number ANLM40AG, UDI/DI 191072232076, Lot Number 42-8831811;  Model/Item Number ANLM40AG, UDI/DI 191072232076, Lot Number 42-8853011;  Model/Item Number ANLM40AG, UDI/DI 191072232076, Lot Number 42-8868811.","more_code_info":""},{"status":"Ongoing","city":"Tiffin","state":"OH","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99482","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":"E-Mail","distribution_pattern":"US distribution to states of:  MN, MO, IA","recall_number":"Z-2990-2026","product_description":"American Contract Systems medical procedure kits and trays labeled as:    1) ANTERIOR CERVICAL PACK - 205988, Model Item Number MHAC65AH;   2) SPINE PACK - 206013, Model Item Number MHSP99AF.","product_quantity":"160 kits","reason_for_recall":"The recall notice was initiated due to a Medicom Urgent Medical Device Recall. Medicom is recalling specific lots of Ritmed¿ Neurological Sponges Non-Sterile Models 55992C to 55998C due to potential for unexpected variability of endotoxin levels on the products.","recall_initiation_date":"20260519","center_classification_date":"20260820","report_date":"20260826","code_info":"Model/Item Number MHAC65AH, UDI/DI 191072211910, Lot Number 42-8606211;  Model/Item Number MHAC65AH, UDI/DI 191072211910, Lot Number 42-8687611;  Model/Item Number MHAC65AH, UDI/DI 191072211910, Lot Number 42-8847511;  Model/Item Number MHSP99AF, UDI/DI 191072214782, Lot Number 42-8423411;  Model/Item Number MHSP99AF, UDI/DI 191072214782, Lot Number 42-8470411;  Model/Item Number MHSP99AF, UDI/DI 191072214782, Lot Number 42-8527611;  Model/Item Number MHSP99AF, UDI/DI 191072214782, Lot Number 42-8601311;  Model/Item Number MHSP99AF, UDI/DI 191072214782, Lot Number 42-8731511;  Model/Item Number MHSP99AF, UDI/DI 191072214782, Lot Number 42-8795311.","more_code_info":""}]}}