FDA Medical devices recall ·
Halyard medical convenience kits labeled as: 1) A-P PACK - 205936… recall
- Recall number
- Z-3046-2026
- Date
- (initiated May 19, 2026)
- Company / brand
- AVID Medical, Inc.
9000 Westmont Dr, Toano, VA, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 816 kits
- Hazard tags
- Sterility
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
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.
Why was it recalled?
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 should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
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
Distribution
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.
States: Arizona California Colorado Florida Georgia Iowa Illinois Maryland Michigan Minnesota Missouri Mississippi North Carolina Nebraska Ohio Pennsylvania South Dakota Texas Utah Washington Wyoming
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-3046-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.