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U.S. Department of Health and Human Services

Class 2 Device Recall American Contract Systems

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 Class 2 Device Recall American Contract Systemssee related information
Date Initiated by FirmMay 19, 2026
Date PostedAugust 20, 2026
Recall Status1 Open3, Classified
Recall NumberZ-2990-2026
Recall Event ID 99482
Product Classification Orthopedic tray - Product Code OJH
ProductAmerican 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.
Code Information 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.
FEI Number 3008492337
Recalling Firm/
Manufacturer		 American Contract Systems Inc
85 Shaffer Park Dr
Tiffin OH 44883-9290
For Additional Information ContactMarlene Jones
470-280-4277
Manufacturer 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 2		Nonconforming Material/Component
ActionAmerican 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 .
Quantity in Commerce160 kits
DistributionUS distribution to states of: MN, MO, IA
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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