The Recall Desk
HighFDA (Devices)·Z-1438-2023·Announced 2023-05-03

Surgical Kit Light Handle Covers May Separate During Use

ROi CPS LLC is recalling 1,369 sterile surgical convenience kits because light handle covers may separate and fall off during use. The affected kits were distributed nationwide in Florida and Missouri.

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: FDA Class II medical device recall with no illnesses or injuries reported. The hazard is theoretical—covers may separate during surgical use—rather than a confirmed incident of actual harm. Per the rubric, theoretical hazards without reported injury are scored at most 3 (High).

Plain-English summary

ROi CPS LLC is recalling 1,369 sterile surgical convenience kits due to a potential defect affecting light handle covers. The kits include 12 different product types used in various surgical procedures, including total shoulder/hip, total hip, total knee, knee arthroscopy, extremity, basic, hand/foot, and spine surgical packs. The light handle covers are components included in these convenience kits.

The manufacturer was notified by their supplier that the light handle covers may separate from the light handle and fall off during use. The affected kits span 12 lot numbers with expiration dates ranging from May 2024 through December 2024. Documented distribution includes facilities in Florida and Missouri, with nationwide U.S. distribution noted.

Healthcare facilities that have received affected kits should immediately discontinue use and contact ROi CPS LLC for replacement or further instructions. The FDA has classified this as a Class II recall.

The recalled product

Product
Sterile surgical convenience kits: 1. regard Item Number: 880473001, OR01105A - Total Shoulder/Hip; 2. regard Item Number: 880426004, OR01033D - Total Hip; 3. regard Item Number: 880427003, OR01034C - Total Knee; 4. regard Item Number: 880474001, OR01106A - Knee Arthro
Manufacturer
ROi CPS LLC
Category
Medical Device — Surgical Convenience Kits
Hazard
Affected units
1,369

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 (20)

  • 1. Lot #95080
  • exp. 9/7/2024
  • UDI (01)10194717114161(17)240907(10)95080
  • 2. Lot #95381
  • exp. 5/30/2024
  • UDI (01)10194717112341(17)240530(10)95381
  • 3. Lot #95516
  • exp. 9/30/2024
  • UDI (01)10194717112365(17)240930(10)95516
  • 4. Lot #95388
  • exp. 10/29/2024
  • UDI (01)10194717114192(17)241029(10)95388
  • 5. Lot #95310
  • exp. 10/27/2024
  • UDI (01)10194717112778(17)241027(10)95310
  • 6. Lot #95503
  • exp. 12/31/2023
  • UDI (01)10194717112150(17)231231(10)95503
  • 7. Lot #95667
  • UDI (01)10194717113904(17)241029(10)95667

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 →

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Same hazard · component separation

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