ROi CPS LLC: Medical Device Recall in 2021 - (Recall #: Z-0253-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

REGARD Newborn Tray

Product Classification:

Class II

Date Initiated: August 10, 2021

Date Posted: November 24, 2021

Recall Number: Z-0253-2022

Event ID: 88463

Reason for Recall:

Povidone-Iodine swabstick manufactured by PDI, Inc. recalled due to Out of Specifications was used as a component in some of the ROI CPS, LLC products.

Status: Terminated

Product Quantity: 12

Code Information:

Lot number: 86453F

Distribution Pattern:

US Nationwide in the states of FL, LA and MO.

Voluntary or Mandated:

Voluntary: Firm initiated