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
- 22,538
- Deaths
- 2
- Injuries
- 1,559
- Malfunctions
- 20,825
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
- 2026-10-07Open, ClassifiedProcess change control
DAVINCI TRUCUSTOM BUNDLE; Model/Item Number (Kit): 1. SAMM064-27, 2. SAMM064-28;
Product may be potentially contaminated with a lubricant used during the manufacturing process.
- 2026-10-07Open, ClassifiedProcess change control
GYN LAPAROSCOPY/LAPAROTOMY; Model/Item Number (Kit): 1. WRNM002-15, 2. FBCH108-03;
Product may be potentially contaminated with a lubricant used during the manufacturing process.
- 2026-10-07Open, ClassifiedProcess change control
LAPAROSCOPIC PROSTATECTOMY; Model/Item Number (Kit): NIHB0036-07;
Product may be potentially contaminated with a lubricant used during the manufacturing process.
- 2026-10-07Open, ClassifiedProcess change control
PLASTICS TRAY; Model/Item Number (Kit): EURO053;
Product may be potentially contaminated with a lubricant used during the manufacturing process.
- 2026-10-07Open, ClassifiedProcess change control
HEART PREP TRAY; Model/Item Number (Kit): MECV97W;
Product may be potentially contaminated with a lubricant used during the manufacturing process.
- 2026-10-07Open, ClassifiedProcess change control
UROLOGY MAJOR; Model/Item Number (Kit): WRNM058-10;
Product may be potentially contaminated with a lubricant used during the manufacturing process.
- 2026-10-07Open, ClassifiedProcess change control
MAJOR PACK; Model/Item Number (Kit): NIHB0018-11;
Product may be potentially contaminated with a lubricant used during the manufacturing process.
- 2026-09-25Open, ClassifiedUnder Investigation by firm
Presource Packs Containing Stryker StrykeFlow PS and AHTO tube sets: 1) KIT, LAP CHOLE , Catalog Number: PGCGLCBAC; 2) KIT, LAP CHOLE , Catalog Number: PGCGLCBAD; 3) KIT, LAP CHOLE , Catalog Number: PGCGLCBAE; 4) KIT, LAP CHOLE , Catalog Number: PGCGLCB11; 5) KIT, CARDIO MINIMALLY INVASIVE, Catalog Number: PV63CMST5; 6) HMC ROBOTIC PACK , Catalog Number: SBA23RBHNG; 7) HMC ROBOTIC PACK , Catalog Number: SBA23RBHNH; 8) ENS ENDOCHOLEYCYSTECTOMIE 4 , Catalog Number: SBA30EDCLB; 9) LAP CHOLE PACK , Catalog Number: SLC37LCJOB; 10) LAP CHOLE PACK , Catalog Number: SLC37LCJ21; 11) LAP CHOLE PACK , Catalog Number: SLC37LCJ22; 12) PACK GYNE ROBOTIC , Catalog Number: SMA30RBHSA
The kits contain tube sets with handpieces that may leak during use. The impacted devices can have the following failures: fluid leakage from the hand piece that can pool on the floor. The impact can range from user dissatisfaction to the potential for the user of slip and fall.
- 2026-09-24Open, ClassifiedNonconforming Material/Component
Medline Convenience Kits: 1) MFC CRANIOTOMY PACK, Catalog Number: DYNJT8784; 2) SLUH CRANIOTOMY PACK-LF, Catalog Number: DYNJ0369348Q; 3) SLUH CRANIOTOMY PACK-LF, Catalog Number: DYNJ0369348R; 4) SLUH CRANIOTOMY PACK-LF, Catalog Number: DYNJ0369348S; 5) SLUH CRANIOTOMY PACK-LF, Catalog Number: DYNJ0369348T
The kits contain neurological sponges with the potential for unexpected variability of endotoxin levels. Potentially elevated endotoxin levels may present health risks that could require medical intervention, such as neurovascular adverse events, febrile response, and/or local transient inflammation, hypotension, or nausea.
- 2026-09-23Open, ClassifiedPackaging process control
Halyard IV START KIT NON-STERILE; 48 kits per case. Containing BD ChloraPrep Clear - 1 mL Applicator. Kit Model Number: KRIV26-02.
Convenience kits containing BD ChloraPrep Clear - 1 mL Applicator, which may be contaminated with Aspergillus penicillioides.
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