Agency classClass IIOur severity:High FDA (Devices)·Z-1432-2023·Announced 2023-05-03

Sterile Surgical Kits Recalled Due to Light Handle Cover Separation Risk

ROi CPS LLC is recalling 662 sterile surgical convenience kits because light handle covers may separate from the light handle and fall off during use. The 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: FDA Class II recall of surgical kits with a potential hazard (light handle covers may separate during use). No injuries or illnesses are reported in the source text. The hazard is theoretical, placing this at High severity under the rubric for risk-of-harm products without documented harm.

Plain-English summary

ROi CPS LLC is recalling 662 sterile surgical convenience kits due to a defect in the light handle covers. The covers may separate from the light handle and fall off during use. The light handle covers are a component of the surgical kits. The manufacturer was notified of this issue by their supplier.

The recalled kits include six different product types used for various surgical procedures. The affected kits were distributed nationwide in Florida and Missouri.

The affected lot numbers are 95322, 95553, 95438, 95784, 95767, and 95735, with expiration dates ranging from October 29, 2024 to November 30, 2024.

The recalled product

Product: 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…
Manufacturer: ROi CPS LLC
Category: Medical Device — Surgical Kits
Hazard: component-separation
equipment-failure
Affected units: 662

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 (15)

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
UDI (01)10194717110927(17)241029(10)95438
4. Lot #95784
exp. 11/30/2024
UDI (01)10194717116837(17)241130(10)95784
5. Lot #95767
UDI (01)10194717112198(17)241029(10)95767
6. Lot #95735
UDI (01)10194717112174(17)241029(10)95735.

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