Resource Optimization & Innovation Llc: The kits contain an equipment glove component which may contain splits or holes compromising the sterility.

Agency Publication Date: October 7, 2015

Affected Products

Product: regard Item Number: 800091, Sterile, LD0692 - C Section - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure

Lot numbers 17021 and 18153.

Lot Numbers:

numbers

Product: regard Item Number: 800401, Sterile, GS0470 - Lap Pk - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure

Lot numbers 14885, 15130, 15341, 16473, 16517, 17011, 17763, 18081, 18483, 18740, 19106, 19242, 19977, 20399, 20540, 21255, 21599, and 22478.

Lot Numbers:

numbers

Product: regard Item Number: 800407, Sterile, OR0476 - Ortho Pk - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROI, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure

Lot numbers 15004, 17185, and 18086.

Lot Numbers:

numbers

Product: regard Item Number: 800408, Sterile, LD0477 - C-Section Pk - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROI, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure

Lot numbers 15003 and 17187.

Lot Numbers:

numbers

Product: regard Item Number: 800409, Sterile, GS0478 - LAP Chole Pk - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure

Lot numbers 14889, 17433, 18368, 19546, 20844, 22727, and 24273,

Lot Numbers:

numbers

Product: regard Item Number: 800410, Sterile, CV0479 - Open Heart Pk - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure

Lot numbers 15134 and 17453.

Lot Numbers:

numbers

Product: regard Item Number: 800411, Sterile, NU0480 - Neuro Pk - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure

Lot numbers 15144, 17359, and 18635.

Lot Numbers:

numbers

Product: regard Item Number: 800413, Sterile, CV0482 - Vascular Pk - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure

Lot numbers 15019 and 17537.

Lot Numbers:

numbers

Product: regard Item Number: 800414, Sterile, OR0483 - Total Joint Pk - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure

Lot numbers 14978, 17321, 18257, 19550, 21698, 22034, 22838, and 24308

Lot Numbers:

numbers

Product: regard Item Number: 800415, Sterile, OR0484 - Shoulder System Pk - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure

Lot numbers 14976,16518, 18233, 19212, 20544, 21138, 22231, 23249, and 24291.

Lot Numbers:

numbers

Product: regard Item Number: 800416, Sterile, GY0485 - Robotic Hysterectomy Pkg - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure

Lot numbers 14989, 17862, and 19544.

Lot Numbers:

numbers

Product: regard Item Number: 800417, Sterile, GY0486 - Laparoscopy Pk - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure

Lot numbers 14886, 18136, 19831, 22808, and 23940.

Lot Numbers:

numbers

Product: regard Item Number: 800418, Sterile, GY0487 - Major Vaginal Pk - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure

Lot numbers 14888, 15851, 17266, 18655, 20404, and 22929.

Lot Numbers:

numbers

Product: regard Item Number: 800419, Sterile, GY0488 - D&C Pk - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure

Lot numbers 14884, 17222, 17956, 19217, 20716, 22690, and 24307.

Lot Numbers:

numbers

Product: regard Item Number: 800422, Sterile, OR0491 - Arthroscopy Pk - surgical kit containing cover light handle soft, Rx. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure

Lot numbers 15128 and 16654.

Lot Numbers:

numbers

Product: regard Item Number: 800425, Sterile, CV0494 - AV Access Pk -Spohn surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure

Lot numbers 16408 and 18658.

Lot Numbers:

numbers

Product: regard Item Number: 800508, Sterile, LD0586 - C Section - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure

Lot numbers 16153, 19010, 19989, 21287, and 21831.

Lot Numbers:

numbers

Product: regard Item Number: 800514, Sterile, LD0592 - C Section Pack - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROI, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure

Lot numbers 16235, 19073, 19511, 20078, 20239, 20868, and 21849.

Lot Numbers:

numbers

Product: regard Item Number: 800524, Sterile, LD0608 - C Section - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure

Lot numbers 16707 and 18924.

Lot Numbers:

numbers

Product: regard Item Number: 800525, Sterile, OR0609 - Extremity Pack - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure

Lot numbers 17578, 18898, 20235, 21006, 21302, and 22981.

Lot Numbers:

numbers

Product: regard Item Number: 800526, Sterile, ET0610 - Head and Neck - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure

Lot numbers 17579, 19576, 20548, 20642, 21589, 22261, and 24232.

Lot Numbers:

numbers

Product: regard Item Number: 800527, Sterile, OR0611 - Hip Shoulder Pk - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure

Lot numbers 16407, 18358, and 18879.

Lot Numbers:

numbers

Product: regard Item Number: 800528, Sterile, GS0612 - Lap Chole Pk - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure

Lot numbers 16835,18906, and 19507.

Lot Numbers:

numbers

Product: regard Item Number: 800531, Sterile, NU0615 - Neuro Pk - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure

Lot number 17018.

Lot Numbers:

number

Product: regard Item Number: 800532, Sterile, GY0616 - Vaginal Hysterectomy - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure

Lot numbers 17695 and 188144.

Lot Numbers:

numbers

Product: regard Item Number: 800533, Sterile, GS0606 - Abdominal Pk - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure

Lot numbers 17697, 19351, 20560, 22036, and 24025

Lot Numbers:

numbers

Product: regard Item Number: 800535, Sterile, LD0620 - C Section - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure

Lot numbers 16468,19367, and 21015.

Lot Numbers:

numbers

Product: regard Item Number: 800546, Sterile, GS0635 - Abdominal - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure

Lot numbers 17698, 19354, 19508, 20805, 21595, and 22841.

Lot Numbers:

numbers

Product: regard Item Number: 800548, Sterile, OR0637 - Extremity - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure

Lot numbers 16821, and 18550.

Lot Numbers:

numbers

Product: regard Item Number: 800549, Sterile, ET0638 - Head & Neck - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure

Lot numbers 17580, 18551, and 19510.

Lot Numbers:

numbers

Product: regard Item Number: 800550, Sterile, OR0639 - Hip Shoulder - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure

Lot numbers 16657, 18362, 18552, 19853, 22815, 23635, and 24103.

Lot Numbers:

numbers

Product: regard Item Number: 800551, Sterile, GS0640 - Lap Chole - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure

Lot numbers 16584, 18145, 18553, and 18359

Lot Numbers:

numbers

Product: regard Item Number: 800553, Sterile, OR0642 - Total Knee - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure

Lot numbers 17133, 18156, 19422, 19971, 20643, and 21129.

Lot Numbers:

numbers

Product: regard Item Number: 800554, Sterile, GS0643 - Pediatric Basic - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure

Lot numbers 17909, 19130, and 20209.

Lot Numbers:

numbers

Product: regard Item Number: 800555, Sterile, HT0644 - Pediatric Card Cath - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure

Lot number 17439.

Lot Numbers:

number

Product: regard Item Number: 800557, Sterile, LD0646 - C-Section - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure

Lot numbers 16674, 18157, 19155, 20423, and 23433.

Lot Numbers:

numbers

Product: regard Item Number: 800558, Sterile, OR0647 - Extremity - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure

Lot numbers 17699, 19156, 19846, 20237, 20821, and 24132.

Lot Numbers:

numbers

Product: regard Item Number: 800559, Sterile, ET0648 - Head & Neck - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure

Lot numbers 17581, 19365, 20418, 22472, 23381, and 24400.

Lot Numbers:

numbers

Product: regard Item Number: 800560, Sterile, GS0649 - Lap Chole - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure

Lot numbers 16696, 19356, 21147, and 22834.

Lot Numbers:

numbers

Product: regard Item Number: 800562, Sterile, NU0651 - Neuro - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure

Lot numbers 16837, 17269, 19413, 19795, 20417, 20970, and 21718.

Lot Numbers:

numbers

Product: regard Item Number: 800565, Sterile, CV0654 - Pediatric Heart - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure

Lot numbers 17478 and 18149

Lot Numbers:

numbers

Product: regard Item Number: 800566, Sterile, NU0655 - VP Shunt - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure

Lot numbers 17911, 19052, 19414, 20220, and 24071.

Lot Numbers:

numbers

Product: regard Item Number: 800567, Sterile, GY0656 - Robotic Hysterectomy - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure

Lot numbers 16574, 18554, and 22612.

Lot Numbers:

numbers

Product: regard Item Number: 800568, Sterile, OR0658 - Titanium Rib - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure

Lot numbers 17134, 18608, and 20166.

Lot Numbers:

numbers

Product: regard Item Number: 800569, Sterile, CV0659 - Open Heart A & B - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure

Lot numbers 16917, 19985, and 22799.

Lot Numbers:

numbers

Product: regard Item Number: 800597, Sterile, GY0688 - LAVH - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure

Lot number 16925.

Lot Numbers:

number

Product: regard Item Number: 800599, Sterile, GS0694 - Robotic Lap - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure

Lot numbers 17261, 19391, 20801, and 22295.

Lot Numbers:

numbers

Product: regard Item Number: 800615, Sterile, CV0741 - Peripheral Vascular - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure

Lot numbers 18390, 18746, 19702, and 20713.

Lot Numbers:

numbers

Product: regard Item Number: 800617, Sterile, NU0768 - Neuro Pk - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure

Lot numbers 20131, 20363, 20500 and 20641.

Lot Numbers:

numbers

Product: regard Item Number: 800623, Sterile, NU0787 - Neuro - surgical kit containing light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure

Lot number 22593.

Lot Numbers:

number

Product: regard Item Number: 880321, Sterile, GS0752 - Breast Pk - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure

Lot numbers 20659 and 23786.

Lot Numbers:

numbers

Product: regard Item Number: 880323, Sterile, LD0754 - C Section - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure

Lot numbers 20407 and 22085.

Lot Numbers:

numbers

Product: regard Item Number: 880326, Sterile, GS0757 - Major Basin - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure

Lot numbers 20661, 21955, and 22229.

Lot Numbers:

numbers

Product: regard Item Number: 880327, Sterile, CV0758 - Open Heart A&B - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure

Lot numbers 21234 and 23256.

Lot Numbers:

numbers

Product: regard Item Number: 880328, Sterile, HT0759 - Pacemaker Pk - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure

Lot numbers 20408, 21922, and 24030.

Lot Numbers:

numbers

Product: regard Item Number: 880330, Sterile, OR0761 - Total Hip - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure

Lot numbers 20409 and 21614.

Lot Numbers:

numbers

Product: regard Item Number: 880331, Sterile, OR0762 - Total Knee - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure

Lot numbers 20197, 22095, and 23379.

Lot Numbers:

numbers

Product: regard Item Number: 800036002, Sterile, LD0274B - C Section Pack - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure

Lot numbers 15259, 16086, 17111, 18127, and 19803.

Lot Numbers:

numbers

Product: regard Item Number: 800036003, Sterile, LD0274C - C Section Pack - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure

Lot numbers 21706, 22052C, and 22405.

Lot Numbers:

numbers

Product: regard Item Number: 800091001, Sterile, LD0692A - C Section - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure

Lot numbers 19386, 20199, 21696, 22303, 22800, and 23232.

Lot Numbers:

numbers

Product: regard Item Number: 800407001, Sterile, OR0476A - Ortho Pk - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure

Lot numbers 19209, 20558, and 22943.

Lot Numbers:

numbers

Product: regard Item Number: 800408001, Sterile, LD0477A - C-Section Pk - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure

Lot numbers 18235, 19608, 20169, 20976, 21911, and 23947.

Lot Numbers:

numbers

Product: regard Item Number: 800410001, Sterile, CV0479A - Open Heart Pk - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure

Lot numbers 20128, 20978, 21157, 22795, 23580, 24104, and 18779.

Lot Numbers:

numbers

Product: regard Item Number: 800411001, Sterile, NU0480A - Neuro Pk - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure

Lot numbers 20112 and 23060.

Lot Numbers:

numbers

Product: regard Item Number: 800411002, Sterile, NU0480B - Neuro Pk - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure

Lot number 24411.

Lot Numbers:

number

Product: regard Item Number: 800413001, Sterile, CV0482A - Vascular Pk - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure

Lot numbers 19412, 19858, 22464, 23253, and 24066.

Lot Numbers:

numbers

Product: regard Item Number: 800422001, Sterile, OR0491A - Arthroscopy Pk - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure

Lot numbers 18921 and 19204.

Lot Numbers:

numbers

Product: regard Item Number: 800524001, Sterile, LD0608A - C Section - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure

Lot numbers 20196, 20647, and 20818.

Lot Numbers:

numbers

Product: regard Item Number: 800528001, Sterile, GS0612A - Lap Chole Pk - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure

Lot numbers 20187, 20502, 22697, and 24264

Lot Numbers:

numbers

Product: regard Item Number: 800554001, Sterile, GS0643A - Pediatric Basic - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure

Lot number 23741.

Lot Numbers:

number

Product: regard Item Number: 800554002, Sterile, GS0643B - Pediatric Basic - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure

Lot number 24602.

Lot Numbers:

number

Product: regard Item Number: 800560001, Sterile, GS0649A - Lap Chole - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure

Lot number 24255.

Lot Numbers:

number

Product: regard Item Number 800565001, Sterile, CV0654A - Pediatric Heart - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure

Lot numbers 19532, 23789, 24399, and 24478.

Lot Numbers:

numbers

Product: regard Item Number 800567001, Sterile, GY0656A - Robotic Hysterectomy - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure

Lot number 24243.

Lot Numbers:

number

Product: regard Item Number 800568001, Sterile, OR0658A - Titanium Rib - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure

Lot number 24486.

Lot Numbers:

number

Product: regard Item Number: 800569001, Sterile, CV0659A - Open Heart A&B - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure

Lot number 24205.

Lot Numbers:

number

Product: regard Item Number: 880327002, sterile, CV0758B - Open Heart A&B - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure

Lot numbers 24298 and 24572.

Lot Numbers:

numbers

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 71904

Status: Resolved

Manufacturer: Resource Optimization & Innovation Llc

Manufactured In: United States

Units Affected: 77 products (26 kits; 7,904 kits; 1,476 kits; 600 kits; 3,099 kits; 199 kits; 904 kits; 288 kits; 874 kits; 832 kits; 324 kits; 400 kits; 296 kits; 1,220 kits; 124 kits; 192 kits; 146 kits; 222 kits; 144 kits; 840 kits; 156 kits; 92 kits; 516 kits; 48 kits; 36 kits; 1,144 kits; 144 kits; 712 kits; 672 kits; 114 kits; 125 kits; 726 kits; 200 kits; 746 kits; 24 kits; 416 kits; 872 kits; 381 kits; 448 kits; 181 kits; 24 kits; 200 kits; 144 kits; 158 kits; 108 kits; 24 kits; 144 kits; 64 kits; 164 kits; 100 kits; 24 kits; 72 kits; 1,233 kits; 54 kits; 40 kits; 24 kits; 40 kits; 658 kits; 388 kits; 68 kits; 1,476 kits; 1,400 kits; 440 kits; 510 kits; 214 kits; 500 kits; 164 kits; 230 kits; 924 kits; 136 kits; 158 kits; 88 kits; 57 kits; 30 kits; 62 kits; 37 kits; 36 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

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

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.

Affected Products

Lot numbers 17021 and 18153.

Lot Numbers:

numbers

Lot numbers 14885, 15130, 15341, 16473, 16517, 17011, 17763, 18081, 18483, 18740, 19106, 19242, 19977, 20399, 20540, 21255, 21599, and 22478.

Lot Numbers:

numbers

Lot numbers 15004, 17185, and 18086.

Lot Numbers:

numbers

Lot numbers 15003 and 17187.

Lot Numbers:

numbers

Lot numbers 14889, 17433, 18368, 19546, 20844, 22727, and 24273,

Lot Numbers:

numbers

Lot numbers 15134 and 17453.

Lot Numbers:

numbers

Lot numbers 15144, 17359, and 18635.

Lot Numbers:

numbers

Lot numbers 15019 and 17537.

Lot Numbers:

numbers

Lot numbers 14978, 17321, 18257, 19550, 21698, 22034, 22838, and 24308

Lot Numbers:

numbers

Lot numbers 14976,16518, 18233, 19212, 20544, 21138, 22231, 23249, and 24291.

Lot Numbers:

numbers

Lot numbers 14989, 17862, and 19544.

Lot Numbers:

numbers

Lot numbers 14886, 18136, 19831, 22808, and 23940.

Lot Numbers:

numbers

Lot numbers 14888, 15851, 17266, 18655, 20404, and 22929.

Lot Numbers:

numbers

Lot numbers 14884, 17222, 17956, 19217, 20716, 22690, and 24307.

Lot Numbers:

numbers

Lot numbers 15128 and 16654.

Lot Numbers:

numbers

Lot numbers 16408 and 18658.

Lot Numbers:

numbers

Lot numbers 16153, 19010, 19989, 21287, and 21831.

Lot Numbers:

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Lot numbers 16235, 19073, 19511, 20078, 20239, 20868, and 21849.

Lot Numbers:

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Lot numbers 16707 and 18924.

Lot Numbers:

numbers

Lot numbers 17578, 18898, 20235, 21006, 21302, and 22981.

Lot Numbers:

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Lot numbers 17579, 19576, 20548, 20642, 21589, 22261, and 24232.

Lot Numbers:

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Lot numbers 16407, 18358, and 18879.

Lot Numbers:

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Lot numbers 16835,18906, and 19507.

Lot Numbers:

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Lot number 17018.

Lot Numbers:

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Lot numbers 17695 and 188144.

Lot Numbers:

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Lot numbers 17697, 19351, 20560, 22036, and 24025

Lot Numbers:

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Lot numbers 16468,19367, and 21015.

Lot Numbers:

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Lot numbers 17698, 19354, 19508, 20805, 21595, and 22841.

Lot Numbers:

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Lot numbers 16821, and 18550.

Lot Numbers:

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Lot numbers 17580, 18551, and 19510.

Lot Numbers:

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Lot numbers 16657, 18362, 18552, 19853, 22815, 23635, and 24103.

Lot Numbers:

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Lot numbers 16584, 18145, 18553, and 18359

Lot Numbers:

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Lot numbers 17133, 18156, 19422, 19971, 20643, and 21129.

Lot Numbers:

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Lot numbers 17909, 19130, and 20209.

Lot Numbers:

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Lot number 17439.

Lot Numbers:

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Lot numbers 16674, 18157, 19155, 20423, and 23433.

Lot Numbers:

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Lot numbers 17699, 19156, 19846, 20237, 20821, and 24132.

Lot Numbers:

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Lot numbers 17581, 19365, 20418, 22472, 23381, and 24400.

Lot Numbers:

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Lot numbers 16696, 19356, 21147, and 22834.

Lot Numbers:

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Lot numbers 16837, 17269, 19413, 19795, 20417, 20970, and 21718.

Lot Numbers:

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Lot numbers 17478 and 18149

Lot Numbers:

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Lot numbers 17911, 19052, 19414, 20220, and 24071.

Lot Numbers:

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Lot numbers 16574, 18554, and 22612.

Lot Numbers:

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Lot numbers 17134, 18608, and 20166.

Lot Numbers:

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Lot numbers 16917, 19985, and 22799.

Lot Numbers:

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Lot number 16925.

Lot Numbers:

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Lot numbers 17261, 19391, 20801, and 22295.

Lot Numbers:

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Lot numbers 18390, 18746, 19702, and 20713.

Lot Numbers:

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Lot numbers 20131, 20363, 20500 and 20641.

Lot Numbers:

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Lot number 22593.

Lot Numbers:

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Lot numbers 20659 and 23786.

Lot Numbers:

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Lot numbers 20407 and 22085.

Lot Numbers:

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Lot numbers 20661, 21955, and 22229.

Lot Numbers:

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Lot numbers 21234 and 23256.

Lot Numbers:

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Lot numbers 20408, 21922, and 24030.

Lot Numbers:

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Lot numbers 20409 and 21614.

Lot Numbers:

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Lot numbers 20197, 22095, and 23379.

Lot Numbers:

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Lot numbers 15259, 16086, 17111, 18127, and 19803.

Lot Numbers:

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Lot numbers 21706, 22052C, and 22405.

Lot Numbers:

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Lot numbers 19386, 20199, 21696, 22303, 22800, and 23232.

Lot Numbers:

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Lot numbers 19209, 20558, and 22943.

Lot Numbers:

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Lot numbers 18235, 19608, 20169, 20976, 21911, and 23947.

Lot Numbers:

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Lot numbers 20128, 20978, 21157, 22795, 23580, 24104, and 18779.

Lot Numbers:

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Lot numbers 20112 and 23060.

Lot Numbers:

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Lot number 24411.

Lot Numbers:

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Lot numbers 19412, 19858, 22464, 23253, and 24066.

Lot Numbers:

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Lot numbers 18921 and 19204.

Lot Numbers:

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Lot numbers 20196, 20647, and 20818.

Lot Numbers:

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Lot numbers 20187, 20502, 22697, and 24264

Lot Numbers:

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Lot number 23741.

Lot Numbers:

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Lot number 24602.

Lot Numbers:

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Lot number 24255.

Lot Numbers:

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Lot numbers 19532, 23789, 24399, and 24478.

Lot Numbers:

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Lot number 24243.

Lot Numbers:

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Lot number 24486.

Lot Numbers:

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Lot number 24205.

Lot Numbers:

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Lot numbers 24298 and 24572.

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Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 71904

Status: Resolved

Manufacturer: Resource Optimization & Innovation Llc

Manufactured In: United States