The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1431-2023·Announced 2023-05-03

Surgical Convenience Kits Recalled for Separating Light Handle Covers

ROi CPS LLC is recalling sterile surgical convenience kits because light handle covers may separate and fall off during use. The recall affects 278 kits distributed in Florida and Missouri.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II recall involving surgical equipment with a risk-of-harm hazard (light handle cover separation during use). The source text does not report any illnesses or injuries, making the hazard theoretical rather than realized, which per the rubric limits the score to at most 3.

Plain-English summary

ROi CPS LLC is recalling sterile surgical convenience kits (Item Numbers 880405003 for General Laparoscopy and 880424004 for Thoracic) due to a component defect. The kits contain light handle covers that may separate and fall off during surgical use.

The recalling firm was notified by their supplier that the light handle covers may separate from the light handle during use. A total of 278 kits were affected, distributed nationwide in Florida and Missouri. Two lots are involved: Lot #95475 (expiration 10/29/2024) and Lot #95493 (expiration 9/7/2024).

Patients and healthcare providers who have received or used these kits should stop use immediately and contact ROi CPS LLC with any questions or concerns.

The recalled product

Product
Sterile surgical convenience kits: 1. regard Item Number: 880405003, GS01011C - General Laparoscopy; 2. regard Item Number: 880424004, GS01031D - Thoracic.
Manufacturer
ROi CPS LLC
Category
Medical Device — Surgical Equipment
Hazard
Affected units
278

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (5)

  • 1. Lot #95475
  • exp. 10/29/2024
  • UDI (01)10194717112211(17)241029(10)95475. 2. Lot #95493
  • exp. 9/7/2024
  • UDI (01)10194717112327(17)240907(10)95493.

Distribution

Distributed nationwide across the United States.

The notice also names 2 states specifically:

Part of a larger recall action

This product is one of 8 recalled by ROi CPS LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 8 products in this recall →

Related recalls

Same manufacturer · ROi CPS LLC

See all →

Same hazard · component separation

See all →

Similar recalls