FDA Medical Device Recalls (openFDA)
ROi CPS LLC: REGARD Vitrectomy Tray
- Recall number
- Z-0256-2022
- Recalling firm
- ROi CPS LLC
- Product
- REGARD Vitrectomy Tray
- Status
- Terminated
- Initiated
- 2021-08-10
- Posted
- not on file
- Terminated
- 2023-06-16
- Reason
- 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.
- Root cause
- Nonconforming Material/Component
- Action
- 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.
- Quantity
- 22 trays
- Distribution
- US Nationwide in the states of FL, LA and MO.
- Lot, serial or model codes
- Lots numbers: 89042C and 85120B
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- OJK
- Firm FEI
- 3014527682
- Firm city
- Republic
- Firm state
- MO
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28