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Open, Classified

American Contract Systems medical procedure kits and trays labeled as: 1) CRANI PACK - 208400, Model Item Number UDCP57AI; 2) SPINE PACK, Model Item Number HSLM53AC; 3) CRANIAL PACK - 205992, Model Item Number MHCP75AH; 4) IMRI CRANI PACK - 213871, Model Item Number ANCI17AO; 5) CRANI PACK - 205942, Model Item Number ANCP30AP; 6) A-P PACK - 205936, Model Item Number ANAP22AP; 7) POSTERIOR PACK - 205960, Model Item Number ANPP15AR; 8) ANTERIOR CERVICAL PACK - 205935, Model Item Number ANAN51AI; 9) LAMINECTOMY PACK - 205957, Model Item Number ANLM40AG.

FDA Recall Z-2989-2026 · Posted 2026-08-20

Recall StatusOpen, Classified
Product CodeOJG
Date Initiated2026-05-19
Product Quantity4789 kits

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.

Firm 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 .

Root Cause

Nonconforming Material/Component

Distribution Pattern

US distribution to states of: MN, MO, IA

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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