Recall Z-2990-2026
American Contract Systems Inc · initiated May 19, 2026
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / lots: 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.
Reason for recall
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.
FDA-determined cause: Nonconforming Material/Component
Action taken
American Contract Systems issued an "URGENT: MEDICAL DEVICE FIELD CORRECTION" on 5/19/2026 with a revision issued on 6/4/2026 via email. The notice explained the issue, risks to health, and requested the consignee affix a recall label from the template provided to the exterior of the kit. The label states: "URGENT: RECALL NOTIFICATION, Prior to use, remove & discard the Medicos Ritmed Neurological Sponge per ACS Recall FA-2026-034." Customers/end-users receiving the product through a distributor were directed to contact the distributor or sales representative with any questions. Complete the Recall Response Form. Distributors were directed to directed to ensure all end-users are appropriately notified and maintain records of effectiveness. If you have any questions, contact the Regulatory Affairs Manager, Global Products by email: GM-OMRA_RECALLS@owens-minor.com or phone at: 470.280.4277 .
Details
- Recall number
- Z-2990-2026
- Initiated
- May 19, 2026
- Posted by FDA
- August 20, 2026
- Product code
- OJH – Orthopedic Tray
- Quantity
- 160 kits
- Distribution
- US distribution to states of: MN, MO, IA
- Recalling firm
- American Contract Systems Inc, Tiffin, OH
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2989-2026 Class II | American Contract Systems medical procedure kits and trays labeled as: 1) CRANI PACK -…The recall notice was initiated due to a Medicom Urgent Medical Device Recall. Medicom is recalling specific… | 05/19/2026Open, Classified |