ROi CPS LLC: Medical Device Recall in 2023 - (Recall #: Z-1432-2023)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.

Product Description:

Sterile surgical convenience kits: 1. regard Item Number: 880353009, GS00797I - Laparotomy Pk; 2. regard Item Number: 880429002, GS01036B - Universal Custom ; 3. regard Item Number: 800725004, GS00930D - OH Base Robot Pack ; 4. regard Item Number: 800725005, GS00930E - OH Base Robot Pack ; 5. regard Item Number: 800395003, GS01000C - Colon Lithotomy and 6. regard Item Number: 880391002, GS00995B - Basic Laparotomy.

Product Classification:

Class II

Date Initiated: March 22, 2023

Date Posted: May 3, 2023

Recall Number: Z-1432-2023

Event ID: 91984

Reason for Recall:

The recalling firm was notified by their supplier that the light handle covers may separate from the light handle and fall off during use. The light handle covers are a kit component.

Status: Ongoing

Product Quantity: 662 kits

Code Information:

1. Lot #95322, exp. 10/29/2024, UDI (01)10194717105015(17)241029(10)95322; 2. Lot #95553, exp. 11/15/2024, UDI (01)10194717112389(17)241115(10)95553; 3. Lot #95438, exp. 10/29/2024, UDI (01)10194717110927(17)241029(10)95438; 4. Lot #95784, exp. 11/30/2024, UDI (01)10194717116837(17)241130(10)95784; 5. Lot #95767, exp. 10/29/2024, UDI (01)10194717112198(17)241029(10)95767; 6. Lot #95735, exp. 10/29/2024, UDI (01)10194717112174(17)241029(10)95735.

Distribution Pattern:

US Nationwide distribution in the states of FL and MO. There was no foreign/military/government distribution.

Voluntary or Mandated:

Voluntary: Firm initiated