The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1437-2023·Announced 2023-05-03

Surgical Convenience Kits Recalled Due to 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 affected 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 with no reported injuries or hospitalizations. The hazard involves a surgical device component that may separate during use, creating a risk of harm in a safety-critical context, but no actual incidents have been reported.

Plain-English summary

ROi CPS LLC is recalling five models of 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, potentially creating a safety hazard in the surgical environment.

The recall involves five kit models: OH Laminectomy (Item #800756005, NU00961E), Lumbar Universal (Item #880411008, NU01018H), Craniotomy (Item #880396007, NU01001G), Anterior/Cervical Spine (Item #880387005, NU00991E), and ORMC Major Crani Pack (Item #800716005, NU00921E). A total of 456 kits were distributed nationwide in Florida and Missouri. Six lot numbers are affected, with expiration dates ranging from May 2024 to November 2024.

If you have received any of these kits, contact ROi CPS LLC immediately for instructions on return, replacement, or destruction of the affected products. Do not use the kits until you have received guidance from the manufacturer. For additional information, contact the FDA or visit the FDA's recall page for this product (Z-1437-2023).

The recalled product

Product
Sterile surgical convenience kits: 1. regard Item Number: 800756005, NU00961E - OH Laminectomy Cust Pack; 2. regard Item Number: 880411008, NU01018H - Lumbar Universal ; 3. regard Item Number: 880396007, NU01001G - Craniotomy ; 4. regard Item: 880387005, NU00991E…
Manufacturer
ROi CPS LLC
Category
Medical Device — Surgical Kits
Hazard
Affected units
456

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 (17)

  • 1. Lot #95370
  • exp. 10/29/2024
  • UDI (01)10194717111023(17)241029(10)95370
  • 2. Lot #95477
  • exp. 6/30/2024
  • UDI (01)10194717112242(17)240630(10)95477
  • 3. Lot #95506
  • exp. 5/31/2024
  • UDI (01)10194717114130(17)240531(10)95506
  • 4. Lot #95632
  • exp. 5/30/2024
  • UDI (01)10194717112709(17)240530(10)95632
  • and 5. Lot #95646
  • exp. 11/15/2024
  • UDI (01)10194717110880(17)241115(10)95646
  • and Lot #95309
  • UDI (01)10194717110880(17)241029(10)95309.

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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