Agency classClass IIOur severity:High FDA (Devices)·Z-1433-2023·Announced 2023-05-03

Sterile surgical kit recalled due to light handle cover separation risk

ROi CPS LLC is recalling sterile surgical convenience kits because light handle covers may separate and fall off during use. Approximately 70 kits were 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: This is an FDA Class II recall of a surgical medical device with a mechanical defect. While no injuries have been reported, the potential for a component to separate and fall during active surgical use represents a documented risk-of-harm scenario that meets the High severity threshold.

Plain-English summary

ROi CPS LLC is recalling sterile surgical convenience kits (WPH Major Vaginal Pack, Item #800718003, Lot #95437, expiration date 11/15/2024). These kits are sterile surgical convenience kits intended for use in medical settings.

The light handle covers, a component of each kit, may separate from the light handle and fall off during surgical use. The recalling firm was notified by their supplier of this defect.

Approximately 70 kits were distributed nationwide in Florida and Missouri.

The recalled product

Product: Sterile surgical convenience kit: regard Item Number: 800718003, GY00923C - WPH Major Vaginal Pack.
Manufacturer: ROi CPS LLC
Category: Medical Device — Surgical Kit
Hazard: component-separation
equipment-defect
Affected units: 70

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 (3)

Lot #95437
exp. 11/15/2024
UDI (01)10194717110903(17)241115(10)95437.

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 →

Same manufacturer · ROi CPS LLC

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Same hazard · component separation