FDA recall Z-2990-2026

American Contract Systems Inc · Class II · device

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.

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.

Distribution

US distribution to states of: MN, MO, IA

Key facts

Status
Ongoing
Initiation date
2026-05-19
Report date
2026-08-26
Voluntary/Mandated
Voluntary: Firm initiated
Location
Tiffin, OH, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2990-2026