openFDA Device Enforcement
Report-date coverage
June 20, 2012–July 08, 2026
Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
openFDA Device Recall
event_date_initiated coverage
June 01, 1997–June 30, 2026
Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.
Product dates, classifications, firms, and source wording remain attached to their individual rows.
Opening this dossier never hides products that did not match a prior timeline filter.
device · product 1 of 77
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
The kits contain an equipment glove component which may contain splits or holes compromising the sterility.
Code information
Lot numbers 17021 and 18153.
Distribution pattern
Distribution was made to LA, MS, and TX.
device · product 2 of 77
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
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
The kits contain an equipment glove component which may contain splits or holes compromising the sterility.
Code information
Lot numbers 15004, 17185, and 18086.
Distribution pattern
Distribution was made to LA, MS, and TX.
device · product 4 of 77
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
The kits contain an equipment glove component which may contain splits or holes compromising the sterility.
Code information
Lot numbers 15003 and 17187.
Distribution pattern
Distribution was made to LA, MS, and TX.
device · product 5 of 77
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
The kits contain an equipment glove component which may contain splits or holes compromising the sterility.
Code information
Lot numbers 14889, 17433, 18368, 19546, 20844, 22727, and 24273,
Distribution pattern
Distribution was made to LA, MS, and TX.
device · product 6 of 77
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
The kits contain an equipment glove component which may contain splits or holes compromising the sterility.
Code information
Lot numbers 15134 and 17453.
Distribution pattern
Distribution was made to LA, MS, and TX.
device · product 7 of 77
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
The kits contain an equipment glove component which may contain splits or holes compromising the sterility.
Code information
Lot numbers 15144, 17359, and 18635.
Distribution pattern
Distribution was made to LA, MS, and TX.
device · product 8 of 77
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
The kits contain an equipment glove component which may contain splits or holes compromising the sterility.
Code information
Lot numbers 15019 and 17537.
Distribution pattern
Distribution was made to LA, MS, and TX.
device · product 9 of 77
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
The kits contain an equipment glove component which may contain splits or holes compromising the sterility.
Code information
Lot numbers 14978, 17321, 18257, 19550, 21698, 22034, 22838, and 24308
Distribution pattern
Distribution was made to LA, MS, and TX.
device · product 10 of 77
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
The kits contain an equipment glove component which may contain splits or holes compromising the sterility.
Code information
Lot numbers 14976,16518, 18233, 19212, 20544, 21138, 22231, 23249, and 24291.
Distribution pattern
Distribution was made to LA, MS, and TX.
device · product 11 of 77
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
The kits contain an equipment glove component which may contain splits or holes compromising the sterility.
Code information
Lot numbers 14989, 17862, and 19544.
Distribution pattern
Distribution was made to LA, MS, and TX.
device · product 12 of 77
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
The kits contain an equipment glove component which may contain splits or holes compromising the sterility.
Code information
Lot numbers 14886, 18136, 19831, 22808, and 23940.
Distribution pattern
Distribution was made to LA, MS, and TX.
device · product 13 of 77
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
The kits contain an equipment glove component which may contain splits or holes compromising the sterility.
Code information
Lot numbers 14888, 15851, 17266, 18655, 20404, and 22929.
Distribution pattern
Distribution was made to LA, MS, and TX.
device · product 14 of 77
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
The kits contain an equipment glove component which may contain splits or holes compromising the sterility.
Code information
Lot numbers 14884, 17222, 17956, 19217, 20716, 22690, and 24307.
Distribution pattern
Distribution was made to LA, MS, and TX.
device · product 15 of 77
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
The kits contain an equipment glove component which may contain splits or holes compromising the sterility.
Code information
Lot numbers 15128 and 16654.
Distribution pattern
Distribution was made to LA, MS, and TX.
device · product 16 of 77
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
The kits contain an equipment glove component which may contain splits or holes compromising the sterility.
Code information
Lot numbers 16408 and 18658.
Distribution pattern
Distribution was made to LA, MS, and TX.
device · product 17 of 77
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
The kits contain an equipment glove component which may contain splits or holes compromising the sterility.
Code information
Lot numbers 16153, 19010, 19989, 21287, and 21831.
Distribution pattern
Distribution was made to LA, MS, and TX.
device · product 18 of 77
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
The kits contain an equipment glove component which may contain splits or holes compromising the sterility.
Code information
Lot numbers 16235, 19073, 19511, 20078, 20239, 20868, and 21849.
Distribution pattern
Distribution was made to LA, MS, and TX.
device · product 19 of 77
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
The kits contain an equipment glove component which may contain splits or holes compromising the sterility.
Code information
Lot numbers 16707 and 18924.
Distribution pattern
Distribution was made to LA, MS, and TX.
device · product 20 of 77
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
The kits contain an equipment glove component which may contain splits or holes compromising the sterility.
Code information
Lot numbers 17578, 18898, 20235, 21006, 21302, and 22981.
Distribution pattern
Distribution was made to LA, MS, and TX.
device · product 21 of 77
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
The kits contain an equipment glove component which may contain splits or holes compromising the sterility.
Code information
Lot numbers 17579, 19576, 20548, 20642, 21589, 22261, and 24232.
Distribution pattern
Distribution was made to LA, MS, and TX.
device · product 22 of 77
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
The kits contain an equipment glove component which may contain splits or holes compromising the sterility.
Code information
Lot numbers 16407, 18358, and 18879.
Distribution pattern
Distribution was made to LA, MS, and TX.
device · product 23 of 77
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
The kits contain an equipment glove component which may contain splits or holes compromising the sterility.
Code information
Lot numbers 16835,18906, and 19507.
Distribution pattern
Distribution was made to LA, MS, and TX.
device · product 24 of 77
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
The kits contain an equipment glove component which may contain splits or holes compromising the sterility.
Code information
Lot number 17018.
Distribution pattern
Distribution was made to LA, MS, and TX.
device · product 25 of 77
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
The kits contain an equipment glove component which may contain splits or holes compromising the sterility.
Code information
Lot numbers 17695 and 188144.
Distribution pattern
Distribution was made to LA, MS, and TX.
device · product 26 of 77
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
The kits contain an equipment glove component which may contain splits or holes compromising the sterility.
Code information
Lot numbers 17697, 19351, 20560, 22036, and 24025
Distribution pattern
Distribution was made to LA, MS, and TX.
device · product 27 of 77
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
The kits contain an equipment glove component which may contain splits or holes compromising the sterility.
Code information
Lot numbers 16468,19367, and 21015.
Distribution pattern
Distribution was made to LA, MS, and TX.
device · product 28 of 77
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
The kits contain an equipment glove component which may contain splits or holes compromising the sterility.
Code information
Lot numbers 17698, 19354, 19508, 20805, 21595, and 22841.
Distribution pattern
Distribution was made to LA, MS, and TX.
device · product 29 of 77
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
The kits contain an equipment glove component which may contain splits or holes compromising the sterility.
Code information
Lot numbers 16821, and 18550.
Distribution pattern
Distribution was made to LA, MS, and TX.
device · product 30 of 77
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
The kits contain an equipment glove component which may contain splits or holes compromising the sterility.
Code information
Lot numbers 17580, 18551, and 19510.
Distribution pattern
Distribution was made to LA, MS, and TX.
device · product 31 of 77
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
The kits contain an equipment glove component which may contain splits or holes compromising the sterility.
Code information
Lot numbers 16657, 18362, 18552, 19853, 22815, 23635, and 24103.
Distribution pattern
Distribution was made to LA, MS, and TX.
device · product 32 of 77
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
The kits contain an equipment glove component which may contain splits or holes compromising the sterility.
Code information
Lot numbers 16584, 18145, 18553, and 18359
Distribution pattern
Distribution was made to LA, MS, and TX.
device · product 33 of 77
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
The kits contain an equipment glove component which may contain splits or holes compromising the sterility.
Code information
Lot numbers 17133, 18156, 19422, 19971, 20643, and 21129.
Distribution pattern
Distribution was made to LA, MS, and TX.
device · product 34 of 77
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
The kits contain an equipment glove component which may contain splits or holes compromising the sterility.
Code information
Lot numbers 17909, 19130, and 20209.
Distribution pattern
Distribution was made to LA, MS, and TX.
device · product 35 of 77
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
The kits contain an equipment glove component which may contain splits or holes compromising the sterility.
Code information
Lot number 17439.
Distribution pattern
Distribution was made to LA, MS, and TX.
device · product 36 of 77
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
The kits contain an equipment glove component which may contain splits or holes compromising the sterility.
Code information
Lot numbers 16674, 18157, 19155, 20423, and 23433.
Distribution pattern
Distribution was made to LA, MS, and TX.
device · product 37 of 77
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
The kits contain an equipment glove component which may contain splits or holes compromising the sterility.
Code information
Lot numbers 17699, 19156, 19846, 20237, 20821, and 24132.
Distribution pattern
Distribution was made to LA, MS, and TX.
device · product 38 of 77
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
The kits contain an equipment glove component which may contain splits or holes compromising the sterility.
Code information
Lot numbers 17581, 19365, 20418, 22472, 23381, and 24400.
Distribution pattern
Distribution was made to LA, MS, and TX.
device · product 39 of 77
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
The kits contain an equipment glove component which may contain splits or holes compromising the sterility.
Code information
Lot numbers 16696, 19356, 21147, and 22834.
Distribution pattern
Distribution was made to LA, MS, and TX.
device · product 40 of 77
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
The kits contain an equipment glove component which may contain splits or holes compromising the sterility.
Code information
Lot numbers 16837, 17269, 19413, 19795, 20417, 20970, and 21718.
Distribution pattern
Distribution was made to LA, MS, and TX.
device · product 41 of 77
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
The kits contain an equipment glove component which may contain splits or holes compromising the sterility.
Code information
Lot numbers 17478 and 18149
Distribution pattern
Distribution was made to LA, MS, and TX.
device · product 42 of 77
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
The kits contain an equipment glove component which may contain splits or holes compromising the sterility.
Code information
Lot numbers 17911, 19052, 19414, 20220, and 24071.
Distribution pattern
Distribution was made to LA, MS, and TX.
device · product 43 of 77
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
The kits contain an equipment glove component which may contain splits or holes compromising the sterility.
Code information
Lot numbers 16574, 18554, and 22612.
Distribution pattern
Distribution was made to LA, MS, and TX.
device · product 44 of 77
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
The kits contain an equipment glove component which may contain splits or holes compromising the sterility.
Code information
Lot numbers 17134, 18608, and 20166.
Distribution pattern
Distribution was made to LA, MS, and TX.
device · product 45 of 77
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
The kits contain an equipment glove component which may contain splits or holes compromising the sterility.
Code information
Lot numbers 16917, 19985, and 22799.
Distribution pattern
Distribution was made to LA, MS, and TX.
device · product 46 of 77
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
The kits contain an equipment glove component which may contain splits or holes compromising the sterility.
Code information
Lot number 16925.
Distribution pattern
Distribution was made to LA, MS, and TX.
device · product 47 of 77
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
The kits contain an equipment glove component which may contain splits or holes compromising the sterility.
Code information
Lot numbers 17261, 19391, 20801, and 22295.
Distribution pattern
Distribution was made to LA, MS, and TX.
device · product 48 of 77
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
The kits contain an equipment glove component which may contain splits or holes compromising the sterility.
Code information
Lot numbers 18390, 18746, 19702, and 20713.
Distribution pattern
Distribution was made to LA, MS, and TX.
device · product 49 of 77
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
The kits contain an equipment glove component which may contain splits or holes compromising the sterility.
Code information
Lot numbers 20131, 20363, 20500 and 20641.
Distribution pattern
Distribution was made to LA, MS, and TX.
device · product 50 of 77
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
The kits contain an equipment glove component which may contain splits or holes compromising the sterility.
Code information
Lot number 22593.
Distribution pattern
Distribution was made to LA, MS, and TX.
device · product 51 of 77
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
The kits contain an equipment glove component which may contain splits or holes compromising the sterility.
Code information
Lot numbers 20659 and 23786.
Distribution pattern
Distribution was made to LA, MS, and TX.
device · product 52 of 77
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
The kits contain an equipment glove component which may contain splits or holes compromising the sterility.
Code information
Lot numbers 20407 and 22085.
Distribution pattern
Distribution was made to LA, MS, and TX.
device · product 53 of 77
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
The kits contain an equipment glove component which may contain splits or holes compromising the sterility.
Code information
Lot numbers 20661, 21955, and 22229.
Distribution pattern
Distribution was made to LA, MS, and TX.
device · product 54 of 77
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
The kits contain an equipment glove component which may contain splits or holes compromising the sterility.
Code information
Lot numbers 21234 and 23256.
Distribution pattern
Distribution was made to LA, MS, and TX.
device · product 55 of 77
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
The kits contain an equipment glove component which may contain splits or holes compromising the sterility.
Code information
Lot numbers 20408, 21922, and 24030.
Distribution pattern
Distribution was made to LA, MS, and TX.
device · product 56 of 77
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
The kits contain an equipment glove component which may contain splits or holes compromising the sterility.
Code information
Lot numbers 20409 and 21614.
Distribution pattern
Distribution was made to LA, MS, and TX.
device · product 57 of 77
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
The kits contain an equipment glove component which may contain splits or holes compromising the sterility.
Code information
Lot numbers 20197, 22095, and 23379.
Distribution pattern
Distribution was made to LA, MS, and TX.
device · product 58 of 77
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
The kits contain an equipment glove component which may contain splits or holes compromising the sterility.
Code information
Lot numbers 15259, 16086, 17111, 18127, and 19803.
Distribution pattern
Distribution was made to LA, MS, and TX.
device · product 59 of 77
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
The kits contain an equipment glove component which may contain splits or holes compromising the sterility.
Code information
Lot numbers 21706, 22052C, and 22405.
Distribution pattern
Distribution was made to LA, MS, and TX.
device · product 60 of 77
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
The kits contain an equipment glove component which may contain splits or holes compromising the sterility.
Code information
Lot numbers 19386, 20199, 21696, 22303, 22800, and 23232.
Distribution pattern
Distribution was made to LA, MS, and TX.
device · product 61 of 77
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
The kits contain an equipment glove component which may contain splits or holes compromising the sterility.
Code information
Lot numbers 19209, 20558, and 22943.
Distribution pattern
Distribution was made to LA, MS, and TX.
device · product 62 of 77
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
The kits contain an equipment glove component which may contain splits or holes compromising the sterility.
Code information
Lot numbers 18235, 19608, 20169, 20976, 21911, and 23947.
Distribution pattern
Distribution was made to LA, MS, and TX.
device · product 63 of 77
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
The kits contain an equipment glove component which may contain splits or holes compromising the sterility.
Code information
Lot numbers 20128, 20978, 21157, 22795, 23580, 24104, and 18779.
Distribution pattern
Distribution was made to LA, MS, and TX.
device · product 64 of 77
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
The kits contain an equipment glove component which may contain splits or holes compromising the sterility.
Code information
Lot numbers 20112 and 23060.
Distribution pattern
Distribution was made to LA, MS, and TX.
device · product 65 of 77
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
The kits contain an equipment glove component which may contain splits or holes compromising the sterility.
Code information
Lot number 24411.
Distribution pattern
Distribution was made to LA, MS, and TX.
device · product 66 of 77
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
The kits contain an equipment glove component which may contain splits or holes compromising the sterility.
Code information
Lot numbers 19412, 19858, 22464, 23253, and 24066.
Distribution pattern
Distribution was made to LA, MS, and TX.
device · product 67 of 77
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
The kits contain an equipment glove component which may contain splits or holes compromising the sterility.
Code information
Lot numbers 18921 and 19204.
Distribution pattern
Distribution was made to LA, MS, and TX.
device · product 68 of 77
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
The kits contain an equipment glove component which may contain splits or holes compromising the sterility.
Code information
Lot numbers 20196, 20647, and 20818.
Distribution pattern
Distribution was made to LA, MS, and TX.
device · product 69 of 77
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
The kits contain an equipment glove component which may contain splits or holes compromising the sterility.
Code information
Lot numbers 20187, 20502, 22697, and 24264
Distribution pattern
Distribution was made to LA, MS, and TX.
device · product 70 of 77
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
The kits contain an equipment glove component which may contain splits or holes compromising the sterility.
Code information
Lot number 23741.
Distribution pattern
Distribution was made to LA, MS, and TX.
device · product 71 of 77
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
The kits contain an equipment glove component which may contain splits or holes compromising the sterility.
Code information
Lot number 24602.
Distribution pattern
Distribution was made to LA, MS, and TX.
device · product 72 of 77
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
The kits contain an equipment glove component which may contain splits or holes compromising the sterility.
Code information
Lot number 24255.
Distribution pattern
Distribution was made to LA, MS, and TX.
device · product 73 of 77
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
The kits contain an equipment glove component which may contain splits or holes compromising the sterility.
Code information
Lot numbers 19532, 23789, 24399, and 24478.
Distribution pattern
Distribution was made to LA, MS, and TX.
device · product 74 of 77
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
The kits contain an equipment glove component which may contain splits or holes compromising the sterility.
Code information
Lot number 24243.
Distribution pattern
Distribution was made to LA, MS, and TX.
device · product 75 of 77
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
The kits contain an equipment glove component which may contain splits or holes compromising the sterility.
Code information
Lot number 24486.
Distribution pattern
Distribution was made to LA, MS, and TX.
device · product 76 of 77
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
The kits contain an equipment glove component which may contain splits or holes compromising the sterility.
Code information
Lot number 24205.
Distribution pattern
Distribution was made to LA, MS, and TX.
device · product 77 of 77
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
