Device recall: regard LAMINECTOMY, NU01140, Item Number 900940; neuro surgery convenience kit

FDA enforcement event 91069 · Class II · initiated 20 Oct 2022 · status Terminated · terminated 1 Apr 2026

DeviceVoluntary: Firm initiated40 product recordsRepublic, MO

ROi CPS LLC (Republic, MO) initiated this device recall on 20 Oct 2022; FDA lists 40 product records under event 91069, classified Class II.

FDA defines Class II as 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. 88% of the 839 device enforcement events initiated in 2022 carry the same class.

Status: Terminated, terminated 1 Apr 2026. Initiation: voluntary: firm initiated. ROi CPS LLC has 28 enforcement events on this register, with a median of 1 product record per event.

Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.

Recalling firm

ROi CPS LLC, Republic, MO.

Reason for recall

"Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled."

Distribution

"LA, MO, NC, FL"

Product records

Recall number	Product	Quantity	Class	Status	Report date
Z-0283-2023	regard LAMINECTOMY, NU01140, Item Number 900940; neuro surgery convenience kit	42 kits	Class II	Terminated	30 Nov 2022
Z-0284-2023	regard FOOT PACK, OR00123Y, Item Number 880118; orthopedic surgery convenience kit	204 kits	Class II	Terminated	30 Nov 2022
Z-0285-2023	regard TOTAL JOINT, OR00446F, Item Number 880291; orthopedic surgery convenience kit	326 kits	Class II	Terminated	30 Nov 2022
Z-0286-2023	regard KYPHOPLASTY, OR01101, Item Number 880469; orthopedic surgery convenience kit	18 kits	Class II	Terminated	30 Nov 2022
Z-0287-2023	regard BASIC NEURO, NU00259R, Item Number 800021018; neuro surgery convenience kit	190 units	Class II	Terminated	30 Nov 2022
Z-0288-2023	regard BASIC NEURO, NU00259S, Item Number 800021019; neuro surgery convenience kit	160 units	Class II	Terminated	30 Nov 2022
Z-0289-2023	regard SPINE PACK, NU00260H, Item Number 800022008; ortho surgery convenience kit	164 units	Class II	Terminated	30 Nov 2022
Z-0290-2023	regard VITRECTOMY PACK, EY00266H, Item Number 800028008; eye surgery convenience kit	76 kits	Class II	Terminated	30 Nov 2022
Z-0291-2023	regard NEURO PACK, NU00278L, Item Number 800040012; nuero surgery convenience kit	69 kits	Class II	Terminated	30 Nov 2022
Z-0292-2023	regard CERVICAL PACK, NU00303H, Item Number 800058008; neuro surgery convenience kit	38 kits	Class II	Terminated	30 Nov 2022
Z-0293-2023	regard MAJOR EAR, ET00326J, Item Number 800070010; ear surgery convenience kit	200 kits	Class II	Terminated	30 Nov 2022
Z-0294-2023	regard SHOULDER W BCH CHAIR, OR00356F, Item Number 800203006; ortho surgery convenience kit	170 kits	Class II	Terminated	30 Nov 2022
Z-0295-2023	regard SPINE PACK,NU00395J, Item Number 800241010; ortho surgery convenience kit	258 kits	Class II	Terminated	30 Nov 2022
Z-0296-2023	regard HAND PACK, OR00594K, Item Number 800243011; ortho surgery convenience kit	38 kits	Class II	Terminated	30 Nov 2022
Z-0297-2023	regard ACDF, NU00698H, Item Number 800246008; neuro surgery convenience kit	20 kits	Class II	Terminated	30 Nov 2022
Z-0298-2023	regard ACDF, NU00698I, Item Number 800246009; neuro surgery convenience kit	30 kits	Class II	Terminated	30 Nov 2022
Z-0299-2023	regard MAJOR CRANI, NU00921E, Item Number 800716005; neuro surgery convenience kit	146 units	Class II	Terminated	30 Nov 2022
Z-0300-2023	regard RETINAL PACK, EY00935C, Item Number 800730003; EYE surgery convenience kit	32 kits	Class II	Terminated	30 Nov 2022
Z-0301-2023	regard VITRECTOMY PK, EY00938C, Item Number 800733003; EYE surgery convenience kit	8 kits	Class II	Terminated	30 Nov 2022
Z-0302-2023	regard SPINE , NU00974F, Item Number 800769006; neuro surgery convenience kit	21 kits	Class II	Terminated	30 Nov 2022
Z-0303-2023	¿regard CV¿PART¿¿1¿BUNDLE¿- MERCY¿ST¿ANTHONY , CV01005H, Item Number 830099008; cardiac surgery convenience kit	108 kits	Class II	Terminated	30 Nov 2022
Z-0304-2023	regard TOTAL HIP ARTHROPLASTY A&B, OR00032W, Item Number 880028023; ortho surgery convenience kit	125 kits	Class II	Terminated	30 Nov 2022
Z-0305-2023	¿regard SHOULDER ARTHROSCOPY, OR00049Q, Item Number 880044017; ortho surgery convenience kit	456 kits	Class II	Terminated	30 Nov 2022
Z-0306-2023	¿regard EYE TRAY, EY00099AE, Item Number 880099031; eye surgery convenience kit	258 kits	Class II	Terminated	30 Nov 2022
Z-0307-2023	regard FOOT PACK - MERCY SPRINGFIELD , OR00123Z, Item Number 880118026; ortho surgery convenience kit	243 kits	Class II	Terminated	30 Nov 2022
Z-0308-2023	¿regard SHOULDER PK, GS00125U, Item Number 880120021; ortho surgery convenience kit	213 kits	Class II	Terminated	30 Nov 2022
Z-0309-2023	regard SHOULDER PACK, GS00125V, Item Number 880120022; ortho surgery convenience kit	177 kits	Class II	Terminated	30 Nov 2022
Z-0310-2023	regard DAVINCI PACK, GS00137W, Item Number 880132023; gastric surgery convenience kit	228 kits	Class II	Terminated	30 Nov 2022
Z-0311-2023	regard MINOR NEURO, NU00140AD, Item Number 880135030; neuro surgery convenience kit	790 kits	Class II	Terminated	30 Nov 2022
Z-0312-2023	regard NEURO TRAY, NU00160R, Item Number 880158018; neuro surgery convenience kit	248 kits	Class II	Terminated	30 Nov 2022
Z-0313-2023	regard SPINE PACK , NU00193N, Item Number 880179014; neuro surgery convenience kit	188 kits	Class II	Terminated	30 Nov 2022
Z-0314-2023	regard MINOR DAVINCI PACK, GS00349M, Item Number 880251013; general surgery convenience kit	268 kits	Class II	Terminated	30 Nov 2022
Z-0315-2023	regard CATARACT, EY00450K, Item Number 880295011; eye surgery convenience kit	738 kits	Class II	Terminated	30 Nov 2022
Z-0316-2023	regard CATARACT, EY00450L, Item Number 880295012; eye surgery convenience kit	780 kits	Class II	Terminated	30 Nov 2022
Z-0317-2023	regard PEDIATRIC UROLOGY, GS00467J, Item Number 880306010; uro surgery convenience kit	166 kits	Class II	Terminated	30 Nov 2022
Z-0318-2023	regard SHOULDER, GS00828G, Item Number 880367007; ortho surgery convenience kit	28 kits	Class II	Terminated	30 Nov 2022
Z-0319-2023	regard LATERAL SHOULDER, OR01044C, Item Number 880435003; ortho surgery convenience kit	54 kits	Class II	Terminated	30 Nov 2022
Z-0320-2023	regard HIP ARTHROSCOPY, OR01092B, Item Number 880462002; ortho surgery convenience kit	24 kits	Class II	Terminated	30 Nov 2022
Z-0321-2023	regard SPINE, OR01100A, Item Number 880468001; ortho surgery convenience kit	302 kits	Class II	Terminated	30 Nov 2022
Z-0322-2023	regard SHOULDER ARTHROSCOPY, OR01103A, Item Number 880471001; ortho surgery convenience kit	90 kits	Class II	Terminated	30 Nov 2022

Context

88%of 2022 device events are Class II839 events that year

40product records in this eventfirm median: 1

28events on this register for the firm

Other enforcement events for ROi CPS LLC

Initiated	Product (first record)	Type	Class	Records
26 Dec 2024	regard Item Number: 830106006, LD01114F - Newborn Kit containing the component Neo-Tee Resuscitator. Convenience kit to	Device	Class I	1
24 Jul 2024	regard Clinical Packaging Solutions, HT00376I - SPECIAL PROCEDURE, Item Number 800223009	Device	Class II	1
17 Jun 2024	Regard Kit containing the Microtek decanter	Device	Class II	1
18 Dec 2023	regard Operative LAP, Item Number 800943001; surgical convenience kit	Device	Class I	1
20 Nov 2023	Regard Dressing change kit, Item Number 800026006	Device	Class I	1
21 Sep 2023	Regard CV PK, Item Numbers a) 880289014, b) 880289015; cardiovascular convenience kit	Device	Class II	1
11 Sep 2023	GS0008 2Y - Burn Pack - STL, Item Number 880082025	Device	Class II	1
22 Mar 2023	Sterile surgical convenience kits: 1. regard Item Number: 880405003, GS01011C - General Laparoscopy; 2. regard Item Numb	Device	Class II	8
3 Jun 2022	Nonsterile convenience kits: (1) regard Item #830099008, CV01005H - CV Part 1 Bundle; and (2) regard Item #830019017, CV	Device	Class II	2
20 May 2022	regard Item Number: 800774001, CV00979A - CV Minor Kit, Sterile.	Device	Class II	1

All 28 events for ROi CPS LLC

Questions and answers

Why was this device recalled?

FDA's record gives the reason for recall as: "Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled."

What does Class II mean?

FDA classifies recalls by relative degree of health hazard. 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.

Where was the product distributed?

FDA's distribution pattern field reads: "LA, MO, NC, FL"

Is the recall still ongoing?

FDA lists the status as Terminated; the termination date is 1 Apr 2026. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.

Where does this data come from?

openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.

Provenance

Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.