American Contract Systems, Inc.: Medical Device Recall in 2022 - (Recall #: Z-1693-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

Product Description:

Various ENT Packs

Product Classification:

Class II

Date Initiated: June 16, 2022

Date Posted: September 14, 2022

Recall Number: Z-1693-2022

Event ID: 90574

Reason for Recall:

Product was exposed to multiple sterilization cycles without validation for multiple exposures.

Status: Ongoing

Product Quantity: 3 units

Code Information:

Tray Number, Sterilization Lot, Lot Number, Bag Serial Number 1) LSRHPENTLHA, 2106181, 838211, 14882942 2) MREN03G, 2104262, 887211, 14934943 3) COEN27K, 2108102, 779211, 15093749-004

Distribution Pattern:

Distribution within the United States to health systems and distributors in AZ, FL, IA, IL, MA, MN, MO, OH, NE, PA, RI, SD, and TX

Voluntary or Mandated:

Voluntary: Firm initiated