Z-2990-2026Class II

American Contract Systems medical procedure kits and trays labeled as: 1) ANTERIOR CERVICAL PACK - 205988...

Name: Z-2990-2026 American Contract Systems medical procedure kits and trays labeled as: 1) ANTERIOR CERVICAL PACK - 205988...
Creator: American Contract Systems Inc
Published: 2026-05-19
License: https://open.fda.gov/license/

American Contract Systems, Inc. / initiated 2026-05-19 / Open, Classified / root cause: manufacturing process

FDA source

American Contract Systems Inc began a recall of American Contract Systems medical procedure kits and trays labeled as: 1) ANTERIOR CERVICAL PACK - 205988, Model Item Number MHAC65AH; 2) SPINE PACK - 206013... on 2026-05-19. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2990-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-05-19
Posted: 2026-08-20
Recalling firm: American Contract Systems, Inc.
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.
Product code: OJH Orthopedic Tray
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.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: 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: [email protected] or phone at: 470.280.4277 .
Quantity in commerce: 160 kits
Distribution: US distribution to states of: MN, MO, IA
Product codes and 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2990-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2989-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-08-26	2026-08-20
Z-2990-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-08-26	2026-08-20

Product code OJH

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-12. View this recall on fda.gov (opens on fda.gov)