FDA Medical devices recall ·
American Contract Systems medical procedure kits and trays labeled as: 1)… recall
- Recall number
- Z-2990-2026
- Date
- (initiated May 19, 2026)
- Company / brand
- American Contract Systems Inc
85 Shaffer Park Dr, Tiffin, OH, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 160 kits
- Hazard tags
- Sterility
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
American Contract Systems medical procedure kits and trays labeled as: 1) ANTERIOR CERVICAL PACK - 205988, Model Item Number MHAC65AH; 2) SPINE PACK - 206013, Model Item Number MHSP99AF.
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 MHAC65AH, UDI/DI 191072211910, Lot Number 42-8606211; Model/Item Number MHAC65AH, UDI/DI 191072211910, Lot Number 42-8687611; Model/Item Number MHAC65AH, UDI/DI 191072211910, Lot Number 42-8847511; Model/Item Number MHSP99AF, UDI/DI 191072214782, Lot Number 42-8423411; Model/Item Number MHSP99AF, UDI/DI 191072214782, Lot Number 42-8470411; Model/Item Number MHSP99AF, UDI/DI 191072214782, Lot Number 42-8527611; Model/Item Number MHSP99AF, UDI/DI 191072214782, Lot Number 42-8601311; Model/Item Number MHSP99AF, UDI/DI 191072214782, Lot Number 42-8731511; Model/Item Number MHSP99AF, UDI/DI 191072214782, Lot Number 42-8795311.
Distribution
US distribution to states of: MN, MO, IA
States: Iowa Minnesota Missouri
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-2990-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.