ROi CPS LLC: Medical Device Recall in 2024 - (Recall #: Z-2685-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2024.

Data Source: FDA.

Product Description:

Regard Kit containing the Microtek decanter

Product Classification:

Class II

Date Initiated: June 17, 2024

Date Posted: August 28, 2024

Recall Number: Z-2685-2024

Event ID: 94999

Reason for Recall:

Decanters may have pin holes and tears in sterile packaging that cannot be identified visually.

Status: Ongoing

Product Quantity: 78 Kits

Code Information:

Item Number: 830099009; UDI: 10194717116677; Lot number's 99206 (Expiration Date: 2024-09-15) and 100633 (Expiration Date: 2024-09-15)

Distribution Pattern:

US Nationwide distribution in the state of MO.

Voluntary or Mandated:

Voluntary: Firm initiated