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FDAFDA · Food and drugs·Recall number Z-3046-2026

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 PACK - 206013, Model/Item Number (kit) MHSP99-01; 7) CRANI PACK, Model/Item Number (kit) WECR41-01.

Published September 9, 2026 · Recall initiated: May 19, 2026

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Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.

What's the hazard

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.

What to do

Voluntary: Firm initiated · E-Mail

Recall details

Manufacturer
AVID Medical, Inc.
Distributor
US 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.
Lot
Model/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.
Risk classification
Class II
Area (FDA)
device
Country
United States

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