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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

Resource Optimization & Innovation Llc: Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.

Agency Publication Date: March 24, 2017
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Affected Products

Product: Regard, Item Number: 800599003, Sterile, GS0694C - Robotic Lap - Christus Highland

037222C Exp Date 2018-08-05; 039975C Exp Date 2018-12-02;

Product: Regard, Item Number: 800535001, Sterile, LD0620A - C Section - New Braunfels

029663A Exp Date: 2017-10-30; 031173A Exp Date 2018-01-25; 032155A Exp Date: 2018-02-28;

Product: Regard, Item Number: 800560003, Sterile, GS0649C - Lap Chole - Childrens Santa Rosa

036887C Exp Date: 2018-07-28; 038469C Exp Date 2018-09-26;

Product: Regard, Item Number: 800623002, Sterile, NU0787B - Neuro - Medical Center Santa Rosa

037598B Exp Date: 2018-07-30;

Product: Regard, Item Number: 800407003, Sterile, OR0476C - Ortho Pk - Spohn

029388C Exp Date: 2017-11-09; 030253C Exp Date: 2017-12-30; 032103C Exp Date: 2018-03-07; 033169C Exp Date: 2018-04-26; 034466C Exp Date: 2018-06-22;

Product: Regard, Item Number: 800414003, Sterile, OR0483C - Total Joint Pk - Spohn

038643C Exp Date 2018-10-05; 039774C Exp Date 2018-11-23

Product: Regard, Item Number: 800566002, Sterile, NU0655B - VP Shunt - Childrens Santa Rosa

028743B Exp Date 2017-03-30; 030250B Exp Date 2017-08-01

Product: Regard, Item Number: 800415001, Sterile, OR0484A - Shoulder System Pk - Spohn

026390A Exp Date 2017-07-13;

Product: Regard, Item Number: 880321001, Sterile, GS0752A - Breast Pk - OSU

027914A Exp Date 2017-08-30;

Product: Regard, Item Number: 800528004, Sterile, GS0612D - Lap Chole Pk - Westover Hills

033493D Exp Date 2018-05-10; 035015D Exp Date 2018-07-12

Product: Regard, Item Number: 800036005, Sterile, LD0274E - C Section Pack - FMOL St Francis

037143E Exp Date 2018-08-05; 038259E Exp Date 2018-09-19; 040326E Exp Date 2018-12-14;

Product: Regard, Item Number: 800091002, Sterile, LD0692B - C Section - FMOL Lady of Angels

026556B Exp Date 2017-07-20; 029081B Exp Date 2017-10-23; 031679B Exp Date 2018-02-19; 032434B Exp Date 2018-03-24; 033616B Exp Date 2018-05-13;

Product: Regard, Item Number: 800091003, Sterile, LD0692C - C Section - FMOL Lady of Angels

034433C Exp Date 2018-06-21; 039905C Exp Date 2018-12-01; 040125C Exp Date 2018-12-08;

Product: Regard, Item Number: 880321002, Sterile, GS0752B - Breast PK - OSU

029000B Exp Date 2017-09-30; 029744B Exp Date 2017-09-30;

Product: Regard, Item Number: 880321003, Sterile, GS0752C - Breast PK - OSU

030874C Exp Date 2017-09-30; 032520C Exp Date 2017-09-30;

Product: Regard, Item Number: 880323001, Sterile, LD0754A - C Section - OSU

027749A Exp Date 2017-08-21; 028525A Exp Date 2017-10-02; 029878A Exp Date 2017-10-30; 032596A Exp Date 2018-02-28; 034309A Exp Date 2018-06-17; 035003A Exp Date 2018-07-11;

Product: Regard, Item Number: 880323002, Sterile, LD0754B - C Section - OSU

037321B Exp Date 2018-08-12

Product: Regard, Item Number: 880323003, Sterile, LD0754C - C Section - OSU

038795C Exp Date 2018-10-11

Product: Regard, Item Number: 880326001, Sterile, GS0757A - Major Basin - OSU

026446A Exp Date 2017-07-16; 030247A Exp Date 2017-12-28; 032384A Exp Date 2018-03-22; 033038A Exp Date 2018-04-20; 034310A Exp Date 2018-06-17;

Product: Regard, Item Number: 880327005, Sterile, CV0758E - Open Heart A&B - OSU

030249E Exp Date 2017-07-30; 031452E Exp Date 2017-07-30;

Product: Regard, Item Number: 880327007, Sterile, CV0758G - Open Heart A&B - OSU

033453G Exp Date 2018-04-30;

Product: Regard, Item Number: 880327008, Sterile, CV0758H - Open Heart A&B - OSU

036916H Exp Date 2018-04-30;

Product: Regard, Item Number: 880327009, Sterile, CV0758I - Open Heart A&B - OSU

039472I Exp Date 2018-04-30;

Product: Regard, Item Number: 880328001, Sterile, HT0759A - Pacemaker Pk - OSU

031483A Exp Date 2017-02-27; 034832A Exp Date 2017-12-03;

Product: Regard, Item Number: 880328002, Sterile, HT0759B - Pacemaker Pk - OSU

037932B Exp Date 2018-05-12; 039334B Exp Date 2018-07-21;

Product: Regard, Item Number: 880330003, Sterile, OR0761C - Total Hip - OSU

030590C Exp Date 2017-10-30; 031852C Exp Date 2017-11-30;

Product: Regard, Item Number: 880330004, Sterile, OR0761D - Total Hip - OSU

033787D Exp Date 2018-03-30; 034306D Exp Date 2018-04-30;

Product: Regard, Item Number: 880330005, Sterile, OR0761E - Total Hip - OSU

037660E Exp Date 2018-04-30

Product: Regard, Item Number: 880331001, Sterile, OR0762A - Total Knee - OSU

031017A Exp Date 2017-11-30; 032617A Exp Date 2018-03-30

Product: Regard, Item Number: 880331002, Sterile, OR0762B - Total Knee - OSU

038832B Exp Date 2018-06-30; 040636B Exp Date 2018-10-31

Product: Regard, Item Number: 880341001, Sterile, GS0775A - Laparoscopic - OSU

026598A Exp Date 2017-06-30; 028130A Exp Date 2017-07-30; 028918A Exp Date 2017-01-30; 029122A Exp Date 2017-09-30; 029906A Exp Date 2017-10-30; 031960A Exp Date 2018-01-30; 033019A Exp Date 2018-04-30;

Product: Regard, Item Number: 880341003, Sterile, GS0775C - Laparoscopic - OSU

037275C Exp Date 2018-08-03;

Product: Regard, Item Number: 880342002, Sterile, GS0776B - Laparotomy - OSU

027338B Exp Date 2017-05-30; 027664B Exp Date 2017-06-30; 028391B Exp Date 2017-07-30; 028752B Exp Date 2017-07-30; 029416B Exp Date 2017-09-30; 030580B Exp Date 2017-10-30; 032134B Exp Date 2018-01-30;

Product: Regard, Item Number: 880342003, Sterile, GS0776C - Laparotomy - OSU

035171C Exp Date 2018-07-14;

Product: Regard, Item Number: 880342004, Sterile, GS0776D - Laparotomy - OSU

039908D Exp Date 2018-12-01;

Product: Regard, Item Number: 800407002, Sterile, OR0476B - Ortho PK - Spohn

027476B Exp Date 2017-08-12;

Product: Regard, Item Number: 800410003, Sterile, CV0479C - Open Heart PK - Spohn

028316C Exp Date 2017-03-30; 028909C Exp Date 2017-03-30

Product: Regard, Item Number: 800413003, Sterile, CV0482C - Vascular PK - Spohn

027502C Exp Date 2017-08-17;

Product: Regard, Item Number: 800414, Sterile, OR0483 - Total Joint PK - Spohn

024308 Exp Date 2017-04-06;

Product: Regard, Item Number: 800414001, Sterile, OR0483A - Total Joint PK - Spohn

028252A Exp Date 2017-09-21;

Product: Regard, Item Number: 800418001, Sterile, GY0487A - Major Vaginal PK - Spohn

026166A Exp Date 2017-07-06;

Product: Regard, Item Number: 800422002, Sterile, OR0491B - Arthroscopy PK - Spohn

027617B Exp Date 2017-08-17;

Product: Regard, Item Number: 800425, Sterile, CV0494 - Av Access PK - Spohn

028153 Exp Date 2017-09-16;

Product: Regard, Item Number: 800508001, Sterile, LD0586A - C Section - Jasper

026200A Exp Date 2017-07-06;

Product: Regard, Item Number: 800524002, Sterile, LD0608B - C Section - Westover Hills

027180B Exp Date 2017-07-27;

Product: Regard, Item Number: 800524003, Sterile, LD0608C - C Section - Westover Hills

029709C Exp Date 2017-11-24; 029888C Exp Date 2017-12-07; 032207C Exp Date 2018-03-24; 033503C Exp Date 2018-05-11

Product: Regard, Item Number: 800524004, Sterile, LD0608D - C Section - Westover Hills

037072D Exp Date 2018-03-30; 038802D Exp Date 2018-07-30;

Product: Regard, Item Number: 800525001, Sterile, OR0609A - Extremity Pack - Westover Hills

031066A Exp Date 2018-01-21; 031996A Exp Date 2018-03-02; 033021A Exp Date 2018-04-19

Product: Regard, Item Number: 800525002 Sterile, OR0609B - Extremity Pack - Westover Hills

034267B Exp Date 2018-06-16; 036852B Exp Date 2018-07-26; 038768B Exp Date 2018-10-10;

Product: Regard, Item Number: 800526002 Sterile, ET0610B - Head and Neck - Westover Hills

033059B Exp Date 2018-04-21; 034067B Exp Date 2018-06-06;

Product: Regard, Item Number: 800526003 Sterile, ET0610C - Head and Neck - Westover Hills

039418C Exp Date 2018-11-04; 040012C Exp Date 2018-12-05;

Product: Regard, Item Number: 800527002 Sterile, OR0611B - Hip Shoulder PK - Westover Hills

029195B Exp Date 2017-09-30;

Product: Regard, Item Number: 800527003 Sterile, OR0611C - Hip Shoulder PK - Westover Hills

031013C Exp Date 2017-11-30; 031667C Exp Date 2017-12-30;

Product: Regard, Item Number: 800527004 Sterile, OR0611D - Hip Shoulder PK - Westover Hills

037607D Exp Date 2018-07-30; 039119D Exp Date 2018-07-30; 039575D Exp Date 2018-08-30;

Product: Regard, Item Number: 800528002 Sterile, GS0612B - Lap Chole PK - Westover Hills

027929B Exp Date 2017-08-30; 029240B Exp Date 2017-09-30; 030080B Exp Date 2017-10-30; 031818B Exp Date 2017-11-30;

Product: Regard, Item Number: 800528005 Sterile, GS0612E - Lap Chole PK - Westover Hills

038284E Exp Date 2018-09-20; 039282E Exp Date 2018-11-01;

Product: Regard, Item Number: 800533002 Sterile, GS0606B - Abdominal PK - Westover Hills

033472B Exp Date 2018-05-09;

Product: Regard, Item Number: 800533003 Sterile, GS0606C - Abdominal PK - Westover Hills

037810C Exp Date 2018-08-30; 039435C Exp Date 2018-11-07

Product: Regard, Item Number: 800535002 Sterile, LD0620B - C Section - New Braunfels

033953B Exp Date 2018-06-02; 036773B Exp Date 2018-07-22

Product: Regard, Item Number: 800535002 Sterile, LD0620B - C Section - New Braunfels

033953B Exp Date 2018-06-02; 036773B Exp Date 2018-07-22

Product: Regard, Item Number: 800546001 Sterile, GS0635A - Abdominal - Medical Center Santa Rosa

030876A Exp Date 2018-01-14; 032509A Exp Date 2018-03-25

Product: Regard, Item Number: 800546002, Sterile, GS0635B - Abdominal - Medical Center Santa Rosa

034265B Exp Date 2018-06-16; 037465B Exp Date 2018-08-17

Product: Regard, Item Number: 800548002, Sterile, OR0637B - Extremity - Medical Center Santa Rosa

034942B Exp Date 2018-07-08; 037820B Exp Date 2018-09-01

Product: Regard, Item Number: 800549002, Sterile, ET0638B - Head & Neck - Medical Center Santa Rosa

034595B Exp Date 2018-06-25;

Product: Regard, Item Number: 800550001, Sterile, OR0639A - Hip Shoulder - Medical Center Santa Rosa

027181A Exp Date 2017-03-30; 030175A Exp Date 2017-03-30; 030570A Exp Date 2017-11-30; 031809A Exp Date 2017-12-30; 032419A Exp Date 2018-03-25; 033639A Exp Date 2018-03-30;

Product: Regard, Item Number: 800550002, Sterile, OR0639B - Hip Shoulder - Medical Center Santa Rosa

037631B Exp Date 2018-07-30;

Product: Regard, Item Number: 800551001, Sterile, GS0640A - Lap Chole - Medical Center Santa Rosa

032891A Exp Date 2018-04-13;

Product: Regard, Item Number: 800551002, Sterile, GS0640B - Lap Chole - Medical Center Santa Rosa

033846B Exp Date 2018-05-26;

Product: Regard, Item Number: 800551003, Sterile, GS0640C - Lap Chole - Medical Center Santa Rosa

038257C Exp Date 2018-09-16; 040017C Exp Date 2018-12-06;

Product: Regard, Item Number: 800553001, Sterile, OR0642A - Total Knee - Medical Center Santa Rosa

030564A Exp Date 2017-11-30; 031034A Exp Date 2017-11-30; 0318321A Exp Date 2018-01-30; 033317A Exp Date 2018-03-30;

Product: Regard, Item Number: 800553002, Sterile, OR0642B - Total Knee - Medical Center Santa Rosa

034869B Exp Date 2018-04-30;

Product: Regard, Item Number: 800553003, Sterile, OR0642C - Total Knee - Medical Center Santa Rosa

039125C Exp Date 2018-07-30; 040256C Exp Date 2018-09-30;

Product: Regard, Item Number: 800554003, Sterile, GS0643C - Pediatric Basic - Childrens Santa Rosa

029078C Exp Date 2017-10-26; 030847C Exp Date 2018-01-12; 030847C Exp Date 2018-03-21;

Product: Regard, Item Number: 800555001, Sterile, HT0644A - Pediatric Card Cath - Childrens Santa Rosa

034203A Exp Date 2017-11-30; 036670A Exp Date 2017-11-30;

Product: Regard, Item Number: 800555002, Sterile, HT0644B - Pediatric Card Cath - Childrens Santa Rosa

037622B Exp Date 2018-08-23; 038777B Exp Date 2018-10-10;

Product: Regard, Item Number: 800557001, Sterile, LD0646A - C Section - Childrens Santa Rosa

027750A Exp Date 2017-08-24; 028676A Exp Date 2017-10-13; 029916A Exp Date 2017-12-08; 030661A Exp Date 2018-01-04; 034835A Exp Date 2018-07-11;

Product: Regard, Item Number: 800557002, Sterile, LD0646B - C Section - Childrens Santa Rosa

037945B Exp Date 2018-09-06; 039741B Exp Date 2018-11-21;

Product: Regard, Item Number: 800558001, Sterile, OR0647A - Extremity - Childrens Santa Rosa

026566A Exp Date 2017-07-20; 030227A Exp Date 2017-12-23;

Product: Regard, Item Number: 800558002, Sterile, OR0647B - Extremity - Childrens Santa Rosa

032157B Exp Date 2018-03-11;

Product: Regard, Item Number: 800558003, Sterile, OR0647C - Extremity - Childrens Santa Rosa

033783C Exp Date 2017-08-30;

Product: Regard, Item Number: 800558004, Sterile, OR0647D - Extremity - Childrens Santa Rosa

037471D Exp Date 2018-08-17; 038772D Exp Date 2018-10-10; 039620D Exp Date 2018-11-16;

Product: Regard, Item Number: 800559001, Sterile, ET0648A - Head & Neck - Childrens Santa Rosa

030203A Exp Date 2017-12-22;

Product: Regard, Item Number: 800559002, Sterile, ET0648B - Head & Neck - Childrens Santa Rosa

032399B Exp Date 2018-03-22; 033495B Exp Date 2018-05-10;

Product: Regard, Item Number: 800559003, Sterile, ET0648C - Head & Neck - Childrens Santa Rosa

034982C Exp Date 2018-07-09; 039451C Exp Date 2018-11-09;

Product: Regard, Item Number: 800560002, Sterile, GS0649B - Lap Chole - Childrens Santa Rosa

028898B Exp Date 2017-10-19; 029882B Exp Date 2017-10-19; 031071B Exp Date 2018-01-25; 033617B Exp Date 2018-05-13;

Product: Regard, Item Number: 800562002, Sterile, NU0651B - Neuro - Childrens Santa Rosa

032109B Exp Date 2018-01-30;

Product: Regard, Item Number: 800567002, Sterile, GY0656B- Robotic Hysterectomy - Alamo

026403B Exp Date 2017-07-13; 029909B Exp Date 2017-12-08; 031012B Exp Date 2018-01-18; 031963B Exp Date 2018-03-01;

Product: Regard, Item Number: 800567003, Sterile, GY0656C - Robotic Hysterectomy - Alamo

034978C Exp Date 2018-07-09; 038090C Exp Date 2018-09-12; 039153C Exp Date 2018-10-26;

Product: Regard, Item Number: 800568005, Sterile, OR0658E - Titanium Rib - Childrens Santa Rosa

037469E Exp Date 2018-06-30;

Product: Regard, Item Number: 800569002, Sterile, CV0659B - Open Heart A&B - Medical Center Santa Rosa

029238B Exp Date 2017-03-30; 030816B Exp Date 2017-11-30; 034258B Exp Date 2018-04-30;

Product: Regard, Item Number: 800569003, Sterile, CV0659C - Open Heart A&B - Medical Center Santa Rosa

038092C Exp Date 2018-07-30; 039713C Exp Date 2018-08-30;

Product: Regard, Item Number: 800599001, Sterile, GS0694A - Robotic Lap - Christus Highland

030226A Exp Date 2017-10-30; 032172A Exp Date 2018-02-28; 032696A Exp Date 2018-03-30; 033176A Exp Date 2018-04-26;

Product: Regard, Item Number: 800599001, Sterile, GS0694A - Robotic Lap - Christus Highland

030226A Exp Date 2017-10-30; 032172A Exp Date 2018-02-28; 032696A Exp Date 2018-03-30; 033176A Exp Date 2018-04-26;

Product: Regard, Item Number: 800623001, Sterile, NU0787A - Neuro - Medical Center Santa Rosa

031463A Exp Date 2017-12-30; 032411A Exp Date 2018-02-28; 032871A Exp Date 2018-03-30; 033654A Exp Date 2018-03-30;

Product: Regard, Item Number: 800401001, Sterile, GS0470A - Lap PK - Spohn

028131A Exp Date 2017-09-16; 028606A Exp Date 2017-10-13; 029244A Exp Date 2017-11-02; 029917A Exp Date 2017-12-08; 030686A Exp Date 2018-01-04; 031323A Exp Date 2018-02-01; 031824A Exp Date 2018-02-24; 032567A Exp Date 2018-03-31; 033054A Exp Date 2018-04-21; 033680A Exp Date 2018-05-19;

Product: Regard, Item Number: 800401002, Sterile, GS0470B - Lap PK - Spohn

034435B Exp Date 2018-6-21; 037051B Exp Date 2018-6-21; 037462B Exp Date 2018-07-29; 038293B Exp Date 2018-08-17; 038779B Exp Date 2018-09-21; 039465B Exp Date 2018-10-10; 040093B Exp Date 2018-11-09;

Product: Regard, Item Number: 800407004, Sterile, OR0476D - Ortho PK - Spohn

038098D Exp Date 2018-9-12; 039573D Exp Date 2018-9-12

Product: Regard, Item Number: 800408002, Sterile, LD0477B - C-Section PK - Spohn

028113B Exp Date 2017-09-15; 030842B Exp Date 2018-01-11; 031792B Exp Date 2018-01-30

Product: Regard, Item Number: 800408003, Sterile, LD0477C - C-Section PK - Spohn

034222S Exp Date 2018-06-14

Product: Regard, Item Number: 800408004, Sterile, LD0477D - C-Section PK - Spohn

037438D Exp Date 2018-8-15; 038495D Exp Date 2018-9-29

Product: Regard, Item Number: 800409002, Sterile, GS0478B - Lap Chole PK - Spohn

027525B Exp Date 2017-08-14; 028915B Exp Date 2017-10-19; 030195B Exp Date 2017-12-21; 031255B Exp Date 2018-01-29; 032688B Exp Date 2017-09-30; 033330B Exp Date 2018-05-03

Product: Regard, Item Number: 800409003, Sterile, GS0478B - Lap Chole PK - Spohn

034494C Exp Date 2018-06-25; 037642C Exp Date 2018-08-25; 038956C Exp Date 2018-10-19; 040142C Exp Date 2018-12-09

Product: Regard, Item Number: 800410004, Sterile, CV0479D- Open Heart PK - Spohn

029922D Exp Date 2017-10-30; 031037D Exp Date 2017-12-30; 032865D Exp Date 2018-3-30

Product: Regard, Item Number: 800410005, Sterile, CV0479E- Open Heart PK - Spohn

034408E Exp Date 2018-04-30; 038488E Exp Date 2018-06-30; 039730E Exp Date 2018-08-30

Product: Regard, Item Number: 800411002, Sterile, NU0480B- Neuro PK - Spohn

027522B Exp Date 2017-03-30; 030020B Exp Date 2017-10-30; 031641B Exp Date 2017-12-30; 033142B Exp Date 2017-12-30; 034112B Exp Date 2018-04-30

Product: Regard, Item Number: 800411003, Sterile, NU0480C- Neuro PK - Spohn

037464C Exp Date 2018-04-30; 038804C Exp Date 2018-04-30; 040546C Exp Date 2018-10-31

Product: Regard, Item Number: 800413004, Sterile, CV0482D- Vascular PK - Spohn

031038D Exp Date 2018-01-19; 032139D Exp Date 2018-03-09; 034081D Exp Date 2018-06-08

Product: Regard, Item Number: 800413005, Sterile, CV0482E- Vascular PK - Spohn

038155E Exp Date 2018-09-15; 039572E Exp Date 2018-11-12

Product: Regard, Item Number: 800414002, Sterile, OR0483B- Total Joint Pk - Spohn

029881B Exp Date 2017-12-04; 030864B Exp Date 2018-01-13; 032446B Exp Date 2018-3-25; 033940B Exp Date 2018-06-02

Product: Regard, Item Number: 800415002, Sterile, OR0484B- Shoulder System Pk - Spohn

029920B Exp Date 2017-12-09; 030885B Exp Date 2018-01-14; 033055B Exp Date 2018-04-21

Product: Regard, Item Number: 800415003, Sterile, OR0484C- Shoulder System Pk - Spohn

037610C Exp Date 2018-08-23; 038494C Exp Date 2018-09-28; 040237C Exp Date 2018-12-09

Product: Regard, Item Number: 800416001, Sterile, GY0485A - Robotic Hysterectomy Pk - Spohn

028912A Exp Date 2017-10-16; 030725A Exp Date 2018-01-08; 031994A Exp Date 2018-03-02; 033625A Exp Date 2018-02-20

Product: Regard, Item Number: 800416002, Sterile, GY0485B - Robotic Hysterectomy Pk - Spohn

035084B Exp Date 2018-07-13; 038325B Exp Date 2018-09-22; 039576B Exp Date 2018-11-12

Product: Regard, Item Number: 800417001, Sterile, GY0486A - Laparoscopy Pk - Spohn

026440A Exp Date 2017-07-16; 030021A Exp Date 2017-12-11; 030186A Exp Date 2017-12-21; 031464A Exp Date 2018-02-15; 032390A Exp Date 2018-03-22; 033782A Exp Date 2018-05-20

Product: Regard, Item Number: 800417002, Sterile, GY0486B - Laparoscopy Pk - Spohn

036643B Exp Date 2018-07-19; 038943B Exp Date 2018-10-17

Product: Regard, Item Number: 800418002, Sterile, GY0487B - Major Vaginal Pk - Spohn

029296B Exp Date 2017-11-04; 030567B Exp Date 2017-12-29; 031350B Exp Date 2018-02-03; 033935B Exp Date 2017-06-30

Product: Regard, Item Number: 800418003, Sterile, GY0487C - Major Vaginal Pk - Spohn

037420C Exp Date 2018-08-12; 039995C Exp Date 2018-12-02

Product: Regard, Item Number: 800419001, Sterile, GY0488A - D&C Pk - Spohn

030228A Exp Date 2017-12-23; 031467A Exp Date 2018-02-09; 032767A Exp Date 2018-04-07

Product: Regard, Item Number: 800419002, Sterile, GY0488B - D&C Pk - Spohn

035042B Exp Date 2018-07-12; 038457B Exp Date 2018-09-23; 039618B Exp Date 2018-11-15

Product: Regard, Item Number: 800422003, Sterile, OR0491C - Arthroscopy Pk - Spohn

031160C Exp Date 2018-01-22; 032881C Exp Date 2018-04-12

Product: Regard, Item Number: 800422004, Sterile, OR0491D - Arthroscopy Pk - Spohn

034404D Exp Date 2018-06-20; 037483D Exp Date 2018-08-18; 039644D Exp Date 2018-11-16

Product: Regard, Item Number: 800425001, Sterile, CV0494A - AV Access Pk - Spohn

030684A Exp Date 2018-01-04; 032158A Exp Date 2018-03-11; 033365A Exp Date 2018-05-05; 034402A Exp Date 2018-06-20

Product: Regard, Item Number: 800425002, Sterile, CV0494B - AV Access Pk - Spohn

037054B Exp Date 2018-07-29; 039606B Exp Date 2018-11-15

Product: Regard, Item Number: 800508002, Sterile, LD0586B - C Section - Jasper

026395B Exp Date 2017-07-13; 027756B Exp Date 2017-08-24; 030702B Exp Date 2018-01-05; 034442B Exp Date 2018-06-21

Product: Regard, Item Number: 800508003, Sterile, LD0586C - C Section - Jasper

037441C Exp Date 2018-08-15

Product: Regard, Item Number: 800508004, Sterile, LD0586D - C Section - Jasper

038465D Exp Date 2018-08-31

Product: Regard, Item Number: 800508004, Sterile, LD0586D - C Section - Jasper

038465D Exp Date 2018-08-31

Product: Regard, Item Number: 800430004, Sterile, LD0499D - C Section Pk - Cabrini

028544D Exp Date 2017-10-06; 031310D Exp Date 2018-01-29; 031515D Exp Date 2018-03-29; 032531D Exp Date 2018-03-29; 034656D Exp Date 2018-06-28

Product: Regard, Item Number: 800430005, Sterile, LD0499E - C Section Pk - Cabrini

037619E Exp Date 2018-08-23; 038962E Exp Date 2018-10-20; 039792E Exp Date 2018-11-29

Product: Regard, Item Number: 800562001, Sterile, NU0651A - Neuro - Childrens Santa Rosa

026545A Exp Date 2017-03-30

Product: Regard, Item Number: 800533001, Sterile, GS0606A - Abdominal Pk - Westover Hills

030102A Exp Date 2017-12-17

Product: Regard, Item Number: 800568002, Sterile, OR0658 - Titanium Rib - Childrens Santa Rosa

028437B Exp Date 2017-08-30; 030579B Exp Date 2017-11-30

Product: Regard, Item Number: 880327006, Sterile, CV0758F - Open Heart A&B - OSU

032677F Exp Date 2017-12-30

Product: Regard, Item Number: 800036004, Sterile, LD0274D - C Section Pack - FMOL St Francis

026385D Exp Date 2017-07-13; 028105D Exp Date 2017-09-14; 029774D Exp Date 2017-12-04; 031980D Exp Date 2018-03-02; 033476D Exp Date 2018-05-10

Product: Regard, Item Number: 800326002, Sterile, GS0757B - Major Basin - OSU

037658B Exp Date 2018-08-26; 038468B Exp Date 2018-09-26; 040771B Exp Date 2018-12-28

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 76255
Status: Resolved
Manufacturer: Resource Optimization & Innovation Llc
Manufactured In: United States
Units Affected: 135 products (41 kits; 46 kits; 210 kits; 90 kits; 2,122 kits; 208 kits; 55 kits; 112 kits; 6 kits; 420 kits; 320 kits; 88 kits; 46 kits; 16 kits; 14 Kits; 156 kits; 30 kits; 42 kits; 1,548 kits; 48 kits; 27 kits; 16 kits; 32 kits; 28 kits; 26 kits; 18 kits; 18 kits; 14 kits; 22 kits; 8 kits; 704 kits; 170 kits; 248 kits; 78 kits; 30 kits; 460 kits; 117 kits; 96 kits; 120 kits; 86 kits; 28 kits; 36 kits; 48 kits; 10 kits; 70 kits; 344 kits; 180 kits; 456 kits; 590 kits; 54 kits; 15 kits; 12 kits; 40 kits; 45 kits; 834 kits; 460 kits; 200 kits; 290 kits; 40 kits; 40 kits; 170 kits; 276 kits; 180 kits; 12 kits; 209 kits; 55 kits; 90 kits; 100 kits; 158 kits; 216 kits; 70 kits; 104 kits; 430 kits; 42 kits; 27 kits; 356 kits; 120 kits; 284 kits; 148 kits; 150 kits; 280 kits; 96 kits; 189 kits; 165 kits; 384 kits; 25 kits; 236 kits; 206 kits; 46 kits; 71 kits; 25 kits; 92 kits; 92 kits; 240 kits; 5,000 kits; 3,000 kits; 840 kits; 690 kits; 230 kits; 430 kits; 2016 kits; 1224 kits; 274 kits; 228 kits; 1056 kits; 436 kits; 372 kits; 164 kits; 496 kits; 382 kits; 208 kits; 288 kits; 249 kits; 216 kits; 92 kits; 148 kits; 56 kits; 450 kits; 350 kits; 110 kits; 162 kits; 306 kits; 118 kits; 126 kits; 24 kits; 32 kits; 32 kits; 454 kits; 212 kits; 30 kits; 210 kits; 90 kits; 30 kits; 670 kits; 660 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.