{"url_path":"/fda/device/recalls/Z-2989-2026","section_key":"summary","section_title":"DEVICE Recall: American Contract Systems Inc — 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 PAC…","topic":"fda","document":{"doc_type":"device-recall","doc_date":"2026-05-19","source_url":"https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2989-2026%22","accession_number":null,"cik":null,"ticker":null,"issuer_name":null,"edgar_url":null,"primary_entity_key":null,"primary_entity_name":"American Contract Systems Inc"},"word_count":668,"has_tables":false,"body_markdown":"# FDA DEVICE Recall: Z-2989-2026\n\n**Recalling firm:** American Contract Systems Inc\n**Classification:** Class II\n**Status:** Ongoing\n**Type:** Voluntary: Firm initiated\n**Initiated:** 2026-05-19\n**Report date:** 2026-08-26\n\n## Product\nAmerican 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.\n\n## Reason\nThe 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.\n\n## Affected lots\nModel/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.\n\n## Distribution\nUS distribution to states of:  MN, MO, IA"}