{"url_path":"/fda/device/recalls/Z-2802-2026","section_key":"summary","section_title":"DEVICE Recall: Windstone Medical Packaging, Inc. — AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as:    1)\tLaminectomy Pack, Pack Number AMS13574A;   2)\tACDF/Fusion Pack, Pack Number AMS14710B;   3)\tSpine Pack, Pack Number AMS14991A;   4)\tSpine Pack, Pack Number AMS14991B;   5)\tSpinal Pack, Pack Number AMS16278;   6)\tSpine Pack, Pack Number AMS16499;   7)\tSpine Pack, Pack Number …","topic":"fda","document":{"doc_type":"device-recall","doc_date":"2026-06-08","source_url":"https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2802-2026%22","accession_number":null,"cik":null,"ticker":null,"issuer_name":null,"edgar_url":null,"primary_entity_key":null,"primary_entity_name":"Windstone Medical Packaging, Inc."},"word_count":398,"has_tables":false,"body_markdown":"# FDA DEVICE Recall: Z-2802-2026\n\n**Recalling firm:** Windstone Medical Packaging, Inc.\n**Classification:** Class II\n**Status:** Ongoing\n**Type:** Voluntary: Firm initiated\n**Initiated:** 2026-06-08\n**Report date:** 2026-08-05\n\n## Product\nAMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as:    1)\tLaminectomy Pack, Pack Number AMS13574A;   2)\tACDF/Fusion Pack, Pack Number AMS14710B;   3)\tSpine Pack, Pack Number AMS14991A;   4)\tSpine Pack, Pack Number AMS14991B;   5)\tSpinal Pack, Pack Number AMS16278;   6)\tSpine Pack, Pack Number AMS16499;   7)\tSpine Pack, Pack Number AMS16709;   8)\tLumbar Spine Pack, Pack Number AMS17336;   9)\tLaminectomy Pack, Pack Number AMS17945;   10)\tAnterior Cervical Pack, Pack Number AMS17946;   11)\tSpine Pack, Pack Number AMS3150F;   12)\tSpine Pack, Pack Number AMS3150G;   13)\tSpine Pack, Pack Number AMS5451D;   14)\tENT Pack, Pack Number AMS9771.\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\n1) Pack Number AMS13574A, UDI B098AMS13574A0, Lot Numbers:  235911, 236897.   2) Pack Number AMS14710B, UDI B098AMS14710B0, Lot Numbers:  224717, 230666, 213914, 236351.   3) Pack Number AMS14991A, UDI B098AMS14991A0, Lot Numbers:  215450, 230108.   4) Pack Number AMS14991B, UDI B098AMS14991B0, Lot Numbers:  233346.   5) Pack Number AMS16278, UDI B098AMS162780, Lot Numbers:  219872, 222999, 226497, 229309, 236465, 237544, 238613.   6) Pack Number AMS16499, UDI B098AMS164990, Lot Numbers:  215711, 218234, 224253, 226168, 226627, 227667, 228446, 230422, 233097, 233399, 233960, 234577, 234907, 236220, 236852, 237358, 238563, 239114, 240373, 241010, 241717.   7) Pack Number AMS16709, UDI B098AMS167090, Lot Numbers:  223361, 225039, 236666, 240344, 241412.   8) Pack Number AMS17336, UDI B098AMS173360, Lot Numbers:  233541, 240967.   9) Pack Number AMS17945, UDI B098AMS179450, Lot Numbers:  235478, 240779, 241565.   10) Pack Number AMS17946, UDI B098AMS179460, Lot Numbers:  235954, 239092, 241514.   11) Pack Number AMS3150F, UDI B098AMS3150F0, Lot Numbers:  211888, 216076, 216357, 218443, 219827, 221799, 223766, 227324, 228151, 229404, 229717, 230623, 231694, 233211, 234586, 234763, 236581, 241332.   12) Pack Number AMS3150G, UDI B098AMS3150G0, Lot Numbers:  242374.   13) Pack Number AMS5451D, UDI B098AMS5451D0, Lot Numbers:  222621, 224568, 238089, 238575, 242113.   14) Pack Number AMS9771, UDI B098AMS97710, Lot Numbers:  176784, 179837, 181956, 184890, 191784, 194017, 196708, 197543, 199137, 201956, 210134, 215434, 217352, 218696, 225332, 226657, 228224, 228678, 230472, 233592, 235614, 236684, 241927.\n\n## Distribution\nUS Nationwide distribution in the states of AZ, CA, CT, GA, IL, MA, MD, NY, OH, PA, TN, TX, VA, WA."}