Device recall
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.
- Recall number
- Z-2990-2026
- Event id
- 99482
- Status
- Ongoing
- FDA classification
- Class II
- Recalling firm
- American Contract Systems Inc
- Report date
- Aug 26, 2026
- Posted
- Aug 20, 2026
- Initiated
- May 19, 2026
- Center classification date
- Aug 20, 2026
- Product code
- OJH
- Device type
- Orthopedic Tray
- Reason
- 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.
- Root cause
- Nonconforming Material/Component
- Quantity
- 160 kits
- Code info
- 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
- Voluntary or mandated
- Voluntary: Firm initiated
- Location
- Tiffin, OH, United States