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Unrated Medical device recall · FDA · Published October 20, 2022

ROi CPS LLC Recalls Gastric Surgery Convenience Kit for 3M Surgical Drapes

ROi CPS LLC recalls gastric surgery convenience kits containing 3M surgical drapes due to potential safety concerns. Affected items include model GS00137W with specific lot numbers and expiration dates.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-0310-2023Medical deviceROi CPS LLC ›
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Contact the company

Recalling firmROi CPS LLC3000 E Sawyer Rd · Republic, MO 65738-2758
✎ GovInfoNow plain-language explainer

ROi CPS LLC has recalled gastric surgery convenience kits that contain 3M surgical drapes. This recall is due to the drapes being part of a previously recalled product line, though no specific safety hazard is mentioned in the record. Read more at govinfonow.com/recall/59821-roi-cps-llc-recalls-gastric-surgery-convenience-kit-for-3m.

Source Summary by GovInfoNow · govinfonow.com/recall/59821-roi-cps-llc-recalls-gastric-surgery-convenience-kit-for-3m · Updated August 18, 2026 · FDA enforcement record: FDA #Z-0310-2023

Cite this page

“ROi CPS LLC Recalls Gastric Surgery Convenience Kit for 3M Surgical Drapes.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/59821-roi-cps-llc-recalls-gastric-surgery-convenience-kit-for-3m. Based on FDA recall #Z-0310-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0310-2023%22&limit=1).

ROi CPS LLC recalled gastric surgery convenience kits distributed in Louisiana, Missouri, North Carolina and Florida because they contained 3M surgical drapes that were subsequently recalled, the FDA said on Oct. 20, 2022.

How to tell if you have it

  • Brand: ROi CPS LLC
  • Product: regard DAVINCI PACK, GS00137W, Item Number 880132023; gastric surgery convenience kit
  • UDI/DI: 10194717113119
  • Lot Numbers: 90987 (exp 12/28/2023), 91804 (exp 3/18/2024), 92715 (exp 6/6/2024)
  • Units affected: 228 kits

The hazard

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

Context

GovInfoNow's records show ROi CPS LLC has 27 other recalls on record since 2020-01-03. Other recent recalls of similar products include Medline Convenience Kits Recall (2026-07-10), Medline ARTHROSCOPY PACK Recall (2026-02-25) and Medline GYN Laparoscopy Kits (2026-02-25).

How to tell if you have this one

Check for the model number GS00137W and lot numbers 90987 (expiring 12/28/2023), 91804 (expiring 3/18/2024), or 92715 (expiring 6/6/2024) on the product packaging.

  • Brand
    ROi CPS LLC
  • Category
    Medical device
FDA recall event · 40 products

All 40 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

  • Classification
    Class II
  • Status
    Terminated
  • Distribution
    LA, MO, NC, FL
Recall numberProduct, codes & lotsQuantity
Z-0283-2023regard LAMINECTOMY, NU01140, Item Number 900940; neuro surgery convenience kit; UDI/DI 10194717110392, Lot Number 91590, exp 01/09/202442 kits
Z-0284-2023regard FOOT PACK, OR00123Y, Item Number 880118; orthopedic surgery convenience kit; UDI/DI 10194717103288, Lot Number 91622, exp 2/22/2024204 kits
Z-0285-2023regard TOTAL JOINT, OR00446F, Item Number 880291; orthopedic surgery convenience kit; UDI/DI 10194717104605, Lot Numbers: 91014, exp 05/01/2023; 92342, exp 07/01/2023; 91672, exp 07/01/2023326 kits
Z-0286-2023regard KYPHOPLASTY, OR01101, Item Number 880469; orthopedic surgery convenience kit; UDI/DI 10194717109723, Lot Numbers: 91417, exp 2/2/202418 kits
Z-0287-2023regard BASIC NEURO, NU00259R, Item Number 800021018; neuro surgery convenience kit; UDI/DI 10194717109914, Lot Numbers: 91329, exp 11/27/2022190 units
Z-0288-2023regard BASIC NEURO, NU00259S, Item Number 800021019; neuro surgery convenience kit; UDI/DI 10194717115397, Lot Numbers: 92346, exp 2/14/2024160 units
Z-0289-2023regard SPINE PACK, NU00260H, Item Number 800022008; ortho surgery convenience kit; UDI/DI 10194717108849, Lot Numbers: 91281, exp 5/28/2023; 91103, exp 10/11/2023164 units
Z-0290-2023regard VITRECTOMY PACK, EY00266H, Item Number 800028008; eye surgery convenience kit; UDI/DI 10194717107897, Lot Numbers: 92222, exp 4/21/202476 kits
Z-0291-2023regard NEURO PACK, NU00278L, Item Number 800040012; nuero surgery convenience kit; UDI/DI 10194717112501, Lot Numbers: 91643, exp 7/1/2023; 91242, exp 8/12/202369 kits
Z-0292-2023regard CERVICAL PACK, NU00303H, Item Number 800058008; neuro surgery convenience kit; UDI/DI 10174717108863, Lot Numbers: 91577, exp 2/7/2023; 91382, exp 12/7/202338 kits
Z-0293-2023regard MAJOR EAR, ET00326J, Item Number 800070010; ear surgery convenience kit; UDI/DI 10194717079958, Lot Numbers: 92037, exp 1/31/2023; 91205, exp 6/30/2023200 kits
Z-0294-2023regard SHOULDER W BCH CHAIR, OR00356F, Item Number 800203006; ortho surgery convenience kit; UDI/DI 10194717107392, Lot Numbers: 91107, exp 1/8/2024; 91879, exp 3/18/2024170 kits
Z-0295-2023regard SPINE PACK,NU00395J, Item Number 800241010; ortho surgery convenience kit; UDI/DI 10194717110767, Lot Numbers: 92051, exp 7/1/2023; 91671, exp 1/29/2024258 kits
Z-0296-2023regard HAND PACK, OR00594K, Item Number 800243011; ortho surgery convenience kit; UDI/DI 10194717110682, Lot Numbers: 92200, exp 4/14/202438 kits
Z-0297-2023regard ACDF, NU00698H, Item Number 800246008; neuro surgery convenience kit; UDI/DI 10194717101314, Lot Numbers: 91760, exp 11/8/202320 kits
Z-0298-2023regard ACDF, NU00698I, Item Number 800246009; neuro surgery convenience kit; UDI/DI 10194717110811, Lot Numbers: 92354, exp 1/31/202330 kits
Z-0299-2023regard MAJOR CRANI, NU00921E, Item Number 800716005; neuro surgery convenience kit; UDI/DI 10174717110880, Lot Numbers: 91522, exp 2/7/2023; 91118, exp 10/18/2023; 91705, exp 12/30/2023; 92034, exp 1/26/2024146 units
Z-0300-2023regard RETINAL PACK, EY00935C, Item Number 800730003; EYE surgery convenience kit; UDI/DI 10194717101611, Lot Numbers: 92674, exp 9/30/2023; 93459, exp 9/30/2023,32 kits
Z-0301-2023regard VITRECTOMY PK, EY00938C, Item Number 800733003; EYE surgery convenience kit; UDI/DI 10194717109297, Lot Numbers: 92327, exp 4/26/20248 kits
Z-0302-2023regard SPINE , NU00974F, Item Number 800769006; neuro surgery convenience kit; UDI/DI 10194717114062, Lot Numbers: 91584, exp 9/23/202321 kits
Z-0303-2023¿regard CV¿PART¿¿1¿BUNDLE¿- MERCY¿ST¿ANTHONY , CV01005H, Item Number 830099008; cardiac surgery convenience kit; UDI/DI 10194717114895, Lot Numbers: 92534, exp 11/13/2022; 93366, exp 2/28/2023108 kits
Z-0304-2023regard TOTAL HIP ARTHROPLASTY A&B, OR00032W, Item Number 880028023; ortho surgery convenience kit; UDI/DI 10194717113911, Lot Numbers: 91560, exp 12/7/2023; 92467, exp 2/14/2024125 kits
Z-0305-2023¿regard SHOULDER ARTHROSCOPY, OR00049Q, Item Number 880044017; ortho surgery convenience kit; UDI/DI 10194717113478, Lot Numbers: 91163, exp 1/10/2024; 91669, exp 2/25/2024; 92537, exp 5/15/2024456 kits
Z-0306-2023¿regard EYE TRAY, EY00099AE, Item Number 880099031; eye surgery convenience kit; UDI/DI 10194717113485, Lot Numbers: 92643, exp 5/24/2024; 93393, exp 8/18/2024; 93669, exp 9/26/2024258 kits
Z-0307-2023regard FOOT PACK - MERCY SPRINGFIELD , OR00123Z, Item Number 880118026; ortho surgery convenience kit; UDI/DI 10194717114789, Lot Numbers: 92274, exp 5/2/2024243 kits
Z-0308-2023¿regard SHOULDER PK, GS00125U, Item Number 880120021; ortho surgery convenience kit; UDI/DI 10194717103301, Lot Numbers: 91005, exp 2/27/2023; 91543, exp 2/16/2024213 kits
Z-0309-2023regard SHOULDER PACK, GS00125V, Item Number 880120022; ortho surgery convenience kit; UDI/DI 10194717114536, Lot Numbers: 92275, exp 4/22/2024177 kits
Z-0310-2023regard DAVINCI PACK, GS00137W, Item Number 880132023; gastric surgery convenience kit; UDI/DI 10194717113119, Lot Numbers: 90987, exp 12/28/2023; 91804, exp 3/18/2024; 92715, exp 6/6/2024228 kits
Z-0311-2023regard MINOR NEURO, NU00140AD, Item Number 880135030; neuro surgery convenience kit; UDI/DI 10194717111306, Lot Numbers: 91012, exp 9/28/2023; 91752, exp 1/29/2024; 92497, exp 2/14/2024790 kits
Z-0312-2023regard NEURO TRAY, NU00160R, Item Number 880158018; neuro surgery convenience kit; UDI/DI 10194717113331, Lot Numbers: 91174, exp 10/18/2023; 91908, exp 2/2/2024; 92566, exp 2/14/2024248 kits
Z-0313-2023regard SPINE PACK , NU00193N, Item Number 880179014; neuro surgery convenience kit; UDI/DI 10194717109457, Lot Numbers: 92239, exp 11/27/2023; 91440, exp 12/7/2023188 kits
Z-0314-2023regard MINOR DAVINCI PACK, GS00349M, Item Number 880251013; general surgery convenience kit; UDI/DI 10194717104322, Lot Numbers: 91465, exp 2/7/2024; 92444, exp 5/5/2024268 kits
Z-0315-2023regard CATARACT, EY00450K, Item Number 880295011; eye surgery convenience kit; UDI/DI 10194717104643, Lot Numbers: 91479, exp 2/10/2024738 kits
Z-0316-2023regard CATARACT, EY00450L, Item Number 880295012; eye surgery convenience kit; UDI/DI 10194717114635, Lot Numbers: 92164, exp 4/7/2024780 kits
Z-0317-2023regard PEDIATRIC UROLOGY, GS00467J, Item Number 880306010; uro surgery convenience kit; UDI/DI 10194717104742, Lot Numbers: 91265, exp 1/20/2024; 92541, exp 5/17/2024166 kits
Z-0318-2023regard SHOULDER, GS00828G, Item Number 880367007; ortho surgery convenience kit; UDI/DI 10194717105121, Lot Numbers: 91778, exp 3/8/202428 kits
Z-0319-2023regard LATERAL SHOULDER, OR01044C, Item Number 880435003; ortho surgery convenience kit; UDI/DI 10194717105763, Lot Numbers: 91403, exp 2/4/2024; 92161, exp 4/12/202454 kits
Z-0320-2023regard HIP ARTHROSCOPY, OR01092B, Item Number 880462002; ortho surgery convenience kit; UDI/DI 10194717109426, Lot Numbers: 90993, exp 10/11/2023; 91722, exp 1/12/202424 kits
Z-0321-2023regard SPINE, OR01100A, Item Number 880468001; ortho surgery convenience kit; UDI/DI 10194717113713, Lot Numbers: 91240, exp 8/3/2023; 92740, exp 2/14/2024302 kits
Z-0322-2023regard SHOULDER ARTHROSCOPY, OR01103A, Item Number 880471001; ortho surgery convenience kit; UDI/DI 10174717114185, Lot Numbers: 92206, exp 1/26/202490 kits
Based on the official FDA remedy

What to do — step by step

  1. Check Product Details

    Identify the model number GS00137W and lot numbers 90987, 91804, or 92715 on the packaging.

Where it went and when

Where it was distributed

Distributed in 4 states.

Alaska: not listedAKMaine: not listedMEVermont: not listedVTNew Hampshire: not listedNHWashington: not listedWAIdaho: not listedIDMontana: not listedMTNorth Dakota: not listedNDMinnesota: not listedMNIllinois: not listedILWisconsin: not listedWIMichigan: not listedMINew York: not listedNYRhode Island: not listedRIMassachusetts: not listedMAOregon: not listedORNevada: not listedNVWyoming: not listedWYSouth Dakota: not listedSDIowa: not listedIAIndiana: not listedINOhio: not listedOHPennsylvania: not listedPANew Jersey: not listedNJConnecticut: not listedCTCalifornia: not listedCAUtah: not listedUTColorado: not listedCONebraska: not listedNEMissouri: yesMOKentucky: not listedKYWest Virginia: not listedWVVirginia: not listedVAMaryland: not listedMDDelaware: not listedDEArizona: not listedAZNew Mexico: not listedNMKansas: not listedKSArkansas: not listedARTennessee: not listedTNNorth Carolina: yesNCSouth Carolina: not listedSCDistrict of Columbia: not listedDCOklahoma: not listedOKLouisiana: yesLAMississippi: not listedMSAlabama: not listedALGeorgia: not listedGAHawaii: not listedHITexas: not listedTXFlorida: yesFL

FDA distribution: “LA, MO, NC, FL” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Florida, Louisiana, Missouri, North Carolina.

Recall timeline

FDA terminated this recall 3.4 years after the firm started it.

1. Firm started the recall: Oct 20, 202212. FDA classified it Class II: Nov 23, 202223. Published in FDA’s Enforcement Report: Nov 30, 202234. FDA terminated the recall: Apr 1, 2026420222026
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report
  4. FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #Z-0310-2023 (October 20, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0310-2023 to see it in context.
  • Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA