ROi CPS LLC REGARD Newborn Tray Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
REGARD Newborn Tray
Brand
ROi CPS LLC
Lot Codes / Batch Numbers
Lot number: 86453F
Products Sold
Lot number: 86453F
ROi CPS LLC is recalling REGARD Newborn Tray due to 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. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
The correction was sent via e-mail on 08-10-2021 instructing the consignees to removed the Swabsticks (3's) and be discarded at time of use.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026