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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device

ROi CPS LLC: Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.

Agency Publication Date: November 23, 2022
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Affected Products

Product: regard BASIC NEURO, NU00259S, Item Number 800021019; neuro surgery convenience kit

UDI/DI 10194717115397, Lot Numbers: 92346, exp 2/14/2024

Lot Numbers:
Numbers
Product: regard SPINE PACK, NU00260H, Item Number 800022008; ortho surgery convenience kit

UDI/DI 10194717108849, Lot Numbers: 91281, exp 5/28/2023; 91103, exp 10/11/2023

Lot Numbers:
Numbers
Product: regard VITRECTOMY PACK, EY00266H, Item Number 800028008; eye surgery convenience kit

UDI/DI 10194717107897, Lot Numbers: 92222, exp 4/21/2024

Lot Numbers:
Numbers
Product: regard NEURO PACK, NU00278L, Item Number 800040012; nuero surgery convenience kit

UDI/DI 10194717112501, Lot Numbers: 91643, exp 7/1/2023; 91242, exp 8/12/2023

Lot Numbers:
Numbers
Product: regard CERVICAL PACK, NU00303H, Item Number 800058008; neuro surgery convenience kit

UDI/DI 10174717108863, Lot Numbers: 91577, exp 2/7/2023; 91382, exp 12/7/2023

Lot Numbers:
Numbers
Product: regard MAJOR EAR, ET00326J, Item Number 800070010; ear surgery convenience kit

UDI/DI 10194717079958, Lot Numbers: 92037, exp 1/31/2023; 91205, exp 6/30/2023

Lot Numbers:
Numbers
Product: regard SHOULDER W BCH CHAIR, OR00356F, Item Number 800203006; ortho surgery convenience kit

UDI/DI 10194717107392, Lot Numbers: 91107, exp 1/8/2024; 91879, exp 3/18/2024

Lot Numbers:
Numbers
Product: regard SPINE PACK,NU00395J, Item Number 800241010; ortho surgery convenience kit

UDI/DI 10194717110767, Lot Numbers: 92051, exp 7/1/2023; 91671, exp 1/29/2024

Lot Numbers:
Numbers
Product: regard HAND PACK, OR00594K, Item Number 800243011; ortho surgery convenience kit

UDI/DI 10194717110682, Lot Numbers: 92200, exp 4/14/2024

Lot Numbers:
Numbers
Product: regard ACDF, NU00698H, Item Number 800246008; neuro surgery convenience kit

UDI/DI 10194717101314, Lot Numbers: 91760, exp 11/8/2023

Lot Numbers:
Numbers
Product: regard ACDF, NU00698I, Item Number 800246009; neuro surgery convenience kit

UDI/DI 10194717110811, Lot Numbers: 92354, exp 1/31/2023

Lot Numbers:
Numbers
Product: regard 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 1/26/2024

Lot Numbers:
Numbers
Product: regard 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,

Lot Numbers:
Numbers
Product: regard VITRECTOMY PK, EY00938C, Item Number 800733003; EYE surgery convenience kit

UDI/DI 10194717109297, Lot Numbers: 92327, exp 4/26/2024

Lot Numbers:
Numbers
Product: regard SPINE , NU00974F, Item Number 800769006; neuro surgery convenience kit

UDI/DI 10194717114062, Lot Numbers: 91584, exp 9/23/2023

Lot Numbers:
Numbers
Product: ¿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 2/28/2023

Lot Numbers:
Numbers
Product: regard 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 2/14/2024

Lot Numbers:
Numbers
Product: ¿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 5/15/2024

Lot Numbers:
Numbers
Product: ¿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 9/26/2024

Lot Numbers:
Numbers
Product: regard FOOT PACK - MERCY SPRINGFIELD , OR00123Z, Item Number 880118026; ortho surgery convenience kit

UDI/DI 10194717114789, Lot Numbers: 92274, exp 5/2/2024

Lot Numbers:
Numbers
Product: ¿regard SHOULDER PK, GS00125U, Item Number 880120021; ortho surgery convenience kit

UDI/DI 10194717103301, Lot Numbers: 91005, exp 2/27/2023; 91543, exp 2/16/2024

Lot Numbers:
Numbers
Product: regard SHOULDER PACK, GS00125V, Item Number 880120022; ortho surgery convenience kit

UDI/DI 10194717114536, Lot Numbers: 92275, exp 4/22/2024

Lot Numbers:
Numbers
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

Lot Numbers:
Numbers
Product: regard 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 2/14/2024

Lot Numbers:
Numbers
Product: regard 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 2/14/2024

Lot Numbers:
Numbers
Product: regard SPINE PACK , NU00193N, Item Number 880179014; neuro surgery convenience kit

UDI/DI 10194717109457, Lot Numbers: 92239, exp 11/27/2023; 91440, exp 12/7/2023

Lot Numbers:
Numbers
Product: regard MINOR DAVINCI PACK, GS00349M, Item Number 880251013; general surgery convenience kit

UDI/DI 10194717104322, Lot Numbers: 91465, exp 2/7/2024; 92444, exp 5/5/2024

Lot Numbers:
Numbers
Product: regard CATARACT, EY00450K, Item Number 880295011; eye surgery convenience kit

UDI/DI 10194717104643, Lot Numbers: 91479, exp 2/10/2024

Lot Numbers:
Numbers
Product: regard CATARACT, EY00450L, Item Number 880295012; eye surgery convenience kit

UDI/DI 10194717114635, Lot Numbers: 92164, exp 4/7/2024

Lot Numbers:
Numbers
Product: regard PEDIATRIC UROLOGY, GS00467J, Item Number 880306010; uro surgery convenience kit

UDI/DI 10194717104742, Lot Numbers: 91265, exp 1/20/2024; 92541, exp 5/17/2024

Lot Numbers:
Numbers
Product: regard SHOULDER, GS00828G, Item Number 880367007; ortho surgery convenience kit

UDI/DI 10194717105121, Lot Numbers: 91778, exp 3/8/2024

Lot Numbers:
Numbers
Product: regard LATERAL SHOULDER, OR01044C, Item Number 880435003; ortho surgery convenience kit

UDI/DI 10194717105763, Lot Numbers: 91403, exp 2/4/2024; 92161, exp 4/12/2024

Lot Numbers:
Numbers
Product: regard HIP ARTHROSCOPY, OR01092B, Item Number 880462002; ortho surgery convenience kit

UDI/DI 10194717109426, Lot Numbers: 90993, exp 10/11/2023; 91722, exp 1/12/2024

Lot Numbers:
Numbers
Product: regard SPINE, OR01100A, Item Number 880468001; ortho surgery convenience kit

UDI/DI 10194717113713, Lot Numbers: 91240, exp 8/3/2023; 92740, exp 2/14/2024

Lot Numbers:
Numbers
Product: regard SHOULDER ARTHROSCOPY, OR01103A, Item Number 880471001; ortho surgery convenience kit

UDI/DI 10174717114185, Lot Numbers: 92206, exp 1/26/2024

Lot Numbers:
Numbers
Product: regard LAMINECTOMY, NU01140, Item Number 900940; neuro surgery convenience kit

UDI/DI 10194717110392, Lot Number 91590, exp 01/09/2024

Lot Numbers:
Number
Product: regard FOOT PACK, OR00123Y, Item Number 880118; orthopedic surgery convenience kit

UDI/DI 10194717103288, Lot Number 91622, exp 2/22/2024

Lot Numbers:
Number
Product: regard 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 07/01/2023

Lot Numbers:
Numbers
Product: regard KYPHOPLASTY, OR01101, Item Number 880469; orthopedic surgery convenience kit

UDI/DI 10194717109723, Lot Numbers: 91417, exp 2/2/2024

Lot Numbers:
Numbers
Product: regard BASIC NEURO, NU00259R, Item Number 800021018; neuro surgery convenience kit

UDI/DI 10194717109914, Lot Numbers: 91329, exp 11/27/2022

Lot Numbers:
Numbers

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 91069
Status: Resolved
Manufacturer: ROi CPS LLC
Manufactured In: United States
Units Affected: 40 products (42 kits; 204 kits; 326 kits; 18 kits; 190 units; 160 units; 164 units; 76 kits; 69 kits; 38 kits; 200 kits; 170 kits; 258 kits; 38 kits; 20 kits; 30 kits; 146 units; 32 kits; 8 kits; 21 kits; 108 kits; 125 kits; 456 kits; 258 kits; 243 kits; 213 kits; 177 kits; 228 kits; 790 kits; 248 kits; 188 kits; 268 kits; 738 kits; 780 kits; 166 kits; 28 kits; 54 kits; 24 kits; 302 kits; 90 kits)

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.