{"url_path":"/fda/device/recalls/Z-3046-2026","section_key":"summary","section_title":"DEVICE Recall: AVID Medical, Inc. — Halyard medical convenience kits labeled as:    1) A-P PACK - 205936, Model/Item Number (kit) ANAP22-01;   2) POSTERIOR PACK - 205960, Model/Item Number (kit) ANPP15-01;   3) ANEURYSM PACK, Model/Item Number (kit) BPAY14-01;   4) SPINE PACK, Model/Item Number (kit) HSLM53-01;   5) ANTERIOR CERVICAL PACK - 205988, Model/Item Number (kit) MHAC65-01;   6) SPINE PA…","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-3046-2026%22","accession_number":null,"cik":null,"ticker":null,"issuer_name":null,"edgar_url":null,"primary_entity_key":null,"primary_entity_name":"AVID Medical, Inc."},"word_count":464,"has_tables":false,"body_markdown":"# FDA DEVICE Recall: Z-3046-2026\n\n**Recalling firm:** AVID Medical, Inc.\n**Classification:** Class II\n**Status:** Ongoing\n**Type:** Voluntary: Firm initiated\n**Initiated:** 2026-05-19\n**Report date:** 2026-09-09\n\n## Product\nHalyard medical convenience kits labeled as:    1) A-P PACK - 205936, Model/Item Number (kit) ANAP22-01;   2) POSTERIOR PACK - 205960, Model/Item Number (kit) ANPP15-01;   3) ANEURYSM PACK, Model/Item Number (kit) BPAY14-01;   4) SPINE PACK, Model/Item Number (kit) HSLM53-01;   5) ANTERIOR CERVICAL PACK - 205988, Model/Item Number (kit) MHAC65-01;   6) SPINE PACK - 206013, Model/Item Number (kit) MHSP99-01;   7) CRANI PACK, Model/Item Number (kit) WECR41-01.\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 (kit) ANAP22-01, UDI/DI 10809160473146, Kit Lot Number 346967;  Model/Item Number (kit) ANAP22-01, UDI/DI 10809160473146, Kit Lot Number 346982;  Model/Item Number (kit) ANPP15-01, UDI/DI 10809160473573, Kit Lot Number 343413;  Model/Item Number (kit) ANPP15-01, UDI/DI 10809160473573, Kit Lot Number 343414;  Model/Item Number (kit) ANPP15-01, UDI/DI 10809160473573, Kit Lot Number 343713;  Model/Item Number (kit) ANPP15-01, UDI/DI 10809160473573, Kit Lot Number 343715;  Model/Item Number (kit) ANPP15-01, UDI/DI 10809160473573, Kit Lot Number 343716;  Model/Item Number (kit) ANPP15-01, UDI/DI 10809160473573, Kit Lot Number 343412;  Model/Item Number (kit) ANPP15-01, UDI/DI 10809160473573, Kit Lot Number 343416;  Model/Item Number (kit) ANPP15-01, UDI/DI 10809160473573, Kit Lot Number 343714;  Model/Item Number (kit) ANPP15-01, UDI/DI 10809160473573, Kit Lot Number 343717;  Model/Item Number (kit) ANPP15-01, UDI/DI 10809160473573, Kit Lot Number 343718;  Model/Item Number (kit) ANPP15-01, UDI/DI 10809160473573, Kit Lot Number 343719;  Model/Item Number (kit) ANPP15-01, UDI/DI 10809160473573, Kit Lot Number 343723;  Model/Item Number (kit) BPAY14-01, UDI/DI 10809160473979, Kit Lot Number 343746;  Model/Item Number (kit) BPAY14-01, UDI/DI 10809160473979, Kit Lot Number 343747;  Model/Item Number (kit) BPAY14-01, UDI/DI 10809160473979, Kit Lot Number 343771;  Model/Item Number (kit) BPAY14-01, UDI/DI 10809160473979, Kit Lot Number 374128;  Model/Item Number (kit) BPAY14-01, UDI/DI 10809160473979, Kit Lot Number 374129;  Model/Item Number (kit) BPAY14-01, UDI/DI 10809160473979, Kit Lot Number 374296;  Model/Item Number (kit) HSLM53-01, UDI/DI 10809160476888, Kit Lot Number 342005;  Model/Item Number (kit) HSLM53-01, UDI/DI 10809160476888, Kit Lot Number 344071;  Model/Item Number (kit) HSLM53-01, UDI/DI 10809160476888, Kit Lot Number 347906;  Model/Item Number (kit) HSLM53-01, UDI/DI 10809160476888, Kit Lot Number 341835;  Model/Item Number (kit) HSLM53-01, UDI/DI 10809160476888, Kit Lot Number 343206;  Model/Item Number (kit) HSLM53-01, UDI/DI 10809160476888, Kit Lot Number 343208;  Model/Item Number (kit) MHAC65-01, UDI/DI 10809160479537, Kit Lot Number 345289;  Model/Item Number (kit) MHSP99-01, UDI/DI 10809160479797, Kit Lot Number 345694;  Model/Item Number (kit) MHSP99-01, UDI/DI 10809160479797, Kit Lot Number 341654;  Model/Item Number (kit) WECR41-01, UDI/DI 10809160485392, Kit Lot Number 344464.\n\n## Distribution\nUS Nationwide distribution in the states of AZ, CA, CO, WA, WY, TX, MI, FL, MD, UT, NC, MS, PA, MO, IA, NE, OH, IL, SD, MN, GA."}