General Surgery Tray
FDA adverse event reports and recall history for general surgery tray (product code LRO), from the public MAUDE corpus and the live FDA recall database.
- Total reports
- 20,596
- Deaths
- 2
- Injuries
- 1,528
- Malfunctions
- 18,921
Reports per year
Source: FDA adverse event reports by year received, 2012–2026. Reporting paused twice in 2026 during FDA reporting-system changes and has since resumed.
Recent recalls
- 2026-08-26Open, ClassifiedProcess change control
Medline convenience kits labeled as: 1) MAJOR GYN PACK, Medline Kit SKU DYNJG001030C; 2) GYN LITHOTOMY PACK, Medline Kit SKU DYNJT8166; 3) OPEN HEART PACK, Medline Kit SKU DYNJ47638B; 4) EAST DAVINCI, Medline Kit SKU DYNJ900949C; 5) THORACIC, Medline Kit SKU DYNJ903470G; 6) CV PART 1 AND 2, Medline Kit SKU DYNJ908879G; 7) GENERAL ROBOTIC, Medline Kit SKU DYNJ910178A; 8) AMB GYN LAPAROSCOPY KT, Medline Kit SKU DYNJ910281B; 9) DIEP FLAP, Medline Kit SKU DYNJ910832A; 10) C-SECTION, Medline Kit SKU DYNJ911236; 11) LAPAROTOMY, Medline Kit SKU DYNJ911243; 12) OPEN HEART A&B, Medline Kit SKU DYNJ911245; 13) TRANSPLANT LIVER BOWEL KIT-LF, Medline Kit SKU DYNJ911332; 14) TRANSPLANT LIVER BOWEL KIT-LF, Medline Kit SKU DYNJ911332A.
Kits contain a potentially contaminated component which were recalled by the manufacturer
- 2026-08-21Open, ClassifiedNonconforming Material/Component
Medline medical convenience kits, labeled as: 1) CRANIOTOMY PACK, Medline Kit SKU DYNJT6545; 2) ORTHO SPINE PACK, Medline Kit SKU DYNJ88056A; 3) ENT SINUS PACK, Medline Kit SKU DYNJ89001; 4) THYROID ENT, Medline Kit SKU DYNJ908641.
Specific item(s) and lot(s) of Medline convenience kits containing Pilling Wecksorb Neurosponges and Neurosponge Strips are being recalled due to potential out-of-specification levels of endotoxin of the neurosponges.
- 2026-08-21Open, ClassifiedLabeling Change Control
Brand Name: Halyard Product Name: DAVINCI TRUCUSTOM BUNDLE containing TRAY FOLEY 16FR W/STATLOCK Model/Catalog Number: SAMM064-27
Labeling Deficiency: The medical kit labeling fails to identify that the statlock component contains natural rubber latex.
- 2026-08-21Open, ClassifiedLabeling Change Control
Halyard TOTAL JOINT Model/Catalog Number: MSBM036-03
Labeling Deficiency: The medical kit labeling fails to identify that the statlock component contains natural rubber latex.
- 2026-08-21Open, ClassifiedLabeling Change Control
Halyard TOTAL JOINT Model/Catalog Number: MSBM036-03
Labeling Deficiency: The medical kit labeling fails to identify that the statlock component contains natural rubber latex.
- 2026-08-21Open, ClassifiedLabeling Change Control
Halyard TOTAL JOINT Model/Catalog Number: MSBM036-03
Labeling Deficiency: The medical kit labeling fails to identify that the statlock component contains natural rubber latex.
- 2026-08-21Open, ClassifiedLabeling Change Control
Halyard TOTAL JOINT Model/Catalog Number: MSBM036-03
Labeling Deficiency: The medical kit labeling fails to identify that the statlock component contains natural rubber latex.
- 2026-08-21Open, ClassifiedLabeling Change Control
Halyard TOTAL JOINT Model/Catalog Number: MSBM036-03
Labeling Deficiency: The medical kit labeling fails to identify that the statlock component contains natural rubber latex.
- 2026-08-21Open, ClassifiedLabeling Change Control
Halyard TOTAL JOINT Model/Catalog Number: MSBM036-03
Labeling Deficiency: The medical kit labeling fails to identify that the statlock component contains natural rubber latex.
- 2026-08-13Open, ClassifiedNonconforming Material/Component
Cardinal Health Presource Kits: 1) FAT GRAFT ADD KIT , Catalog Number: 21-4720B; 2) TRAY FAT GRAFT ADD , Catalog Number: 21-4720C; 3) KIT,BOSC MICROLARYNGOSCOPY , Catalog Number: PECGMLBOB; 4) KIT,ASLMC NASAL PACK , Catalog Number: PECGNAAU8; 5) KIT,ASLMC NASAL PACK , Catalog Number: PECGNAAU8; 6) KIT, TRIPOINT SPINE , Catalog Number: PN1DTSLH9; 7) KIT, TRIPOINT SPINE , Catalog Number: PN1DTSLHC; 8) KIT, TRIPOINT SPINE , Catalog Number: PN1DTSLHD; 9) KIT, TRIPOINT SPINE , Catalog Number: PN1DTSLHE; 10) KIT,NEURO , Catalog Number: PN21OTMC6; 11) KIT,NEURO , Catalog Number: PN21OTMC7; 12) KIT,NEURO , Catalog Number: PN21OTMCC; 13) KIT,NEURO , Catalog Number: PN21OTMCD; 14) KIT, MER CRANI , Catalog Number: PN33CRMYB; 15) KIT,CHP BASIC NEURO , Catalog Number: PN36NBCHB; 16) KIT, CRANIOTOMY , Catalog Number: PN40CKC27; 17) KIT, CRANIOTOMY , Catalog Number: PN40CKC28; 18) KIT, CRANIOTOMY , Catalog Number: PN40CKC29; 19) KIT, CRANIOTOMY , Catalog Number: PN40CKCFC; 20) KIT, BAL LUMBAR LAMINECTOMY , Catalog Number: PNCGLLBMB; 21) KIT, BAL LUMBAR LAMINECTOMY , Catalog Number: PNCGLLBMC; 22) BASIC PACK , Catalog Number: SBA73BPGCA; 23) FACIAL FEMINIZATION PACK , Catalog Number: SBA73FFKW9; 24) EDGECOMBE BASIC MILLER PACK , Catalog Number: SBA95BMHH6; 25) EDGECOMBE BASIC MILLER PACK , Catalog Number: SBA95BMHH7; 26) EDGECOMBE BASIC MILLER PACK , Catalog Number: SBA95BMHH8; 27) EDGECOMBE BASIC MILLER PACK , Catalog Number: SBA95BMHHF; 28) EDGECOMBE BASIC MILLER PACK , Catalog Number: SBA95BMHHG; 29) EDGECOMBE BASIC MILLER PACK , Catalog Number: SBA95BMHHH; 30) TRAM PACK , Catalog Number: SBA95TPD10; 31) TRAM PACK , Catalog Number: SBA95TPD11; 32) TRAM PACK , Catalog Number: SBA95TPDU6; 33) TRAM PACK , Catalog Number: SBA95TPDU7; 34) TRAM PACK , Catalog Number: SBA95TPDU8; 35) TRAM PACK , Catalog Number: SBA95TPDU9; 36) TRAM PACK , Catalog Number: SBA95TPDUP; 37) TRAM PACK , Catalog Number: SBA95TPDUQ; 38) PLASTIC SURGERY PACK ,
Cardinal Health was recently informed of a medical device recall from MEDICOM concerning the Ritmed Neurological Sponges. The recall is being issued due to unexpected variability of endotoxin levels on the products.
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