The Recall Desk
HighFDA (Devices)·Z-1435-2023·Announced 2023-05-03

Sterile Surgical Kit Light Handle Covers May Separate During Use

ROi CPS LLC is recalling 386 sterile surgical convenience kits (WPH GYN Laparoscopy Pack) because light handle covers may separate and fall off during use.

What this means for you

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 a risk-of-harm product (surgical kit with component separation hazard) where no illnesses or injuries have been reported. Per the rubric, this places the recall at a maximum score of 3 (High).

Plain-English summary

ROi CPS LLC is recalling the WPH GYN Laparoscopy Pack, a sterile surgical convenience kit. The recall affects 386 kits identified by item number 800753005, GY00958E, lot #95517, with an expiration date of October 17, 2024.

The light handle covers that are part of this surgical kit may separate from the light handle and fall off during use. The manufacturer was notified of this issue by their supplier.

The affected kits were distributed nationwide to medical facilities in Florida and Missouri. No illnesses or injuries related to this issue have been reported.

The recalled product

Product
Sterile surgical convenience kit: regard Item Number: 800753005, GY00958E - WPH GYN Laparoscopy Pack.
Manufacturer
ROi CPS LLC
Category
Medical Device — Surgical Equipment
Hazard
Affected units
386

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 #95517
  • exp. 10/17/2024
  • UDI (01)10194717108719(17)241017(10)95517.

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 →