Laparoscopy Kit
FDA adverse event reports and recall history for laparoscopy kit (product code FDE), from the public MAUDE corpus and the live FDA recall database.
- Total reports
- 554
- Deaths
- 2
- Injuries
- 42
- Malfunctions
- 506
Reports per year
Source: FDA adverse event reports by year received, 2006–2026. Reporting paused twice in 2026 during FDA reporting-system changes and has since resumed.
Recent recalls
- 2026-10-15Open, ClassifiedUnder Investigation by firm
Medline surgical convenience kits labeled as: 1) MAIN/LAPAROSCOPY TRANSPLA PACK, Medline product number/SKU DYNJ0656274AC; 2) MAIN/LAPAROSCOPY TRANSPLA PACK, Medline product number/SKU DYNJ0656274AB; 3) CATH LAB ENDO AAA, Medline product number/SKU DYNJ35312I; 4) MAIN/LAPAROSCOPY TRANSPLA PACK, Medline product number/SKU DYNJ0656274AA.
Medical convenience kits were distributed containing cannula components which do not conform to ISO 80369-7 dimensional requirements and may contribute to leaking or breaking during use.
- 2026-10-15Open, ClassifiedProcess change control
Convenience Kits containing CONMED AirSeal Access Ports ADVANCE LAPAROSCOPIC DYNJ911135 LAP CHOLE DYNJ911660 LAP NISSEN DYNJ911560 UROLOGY LAPAROSCOPIC - 51638 DYNJ908720A
Kits contain CONMED AirSeal Access Ports. The ports were recalled by manufacturer due to potential for erroneous overpressure alerts and system venting during use, which may result in delays or ending procedures.
- 2026-10-02Open, ClassifiedLabeling design
HALYARD Laparoscopy Comprehensive Pack II REF: 49332
Laparoscopy packs labeled as "latex free" were found to contain a latex urethral catheter
- 2026-09-25Open, ClassifiedUnder Investigation by firm
Medical convenience kits containing BD CliniClean Pericare Wipes within BD Urinary Catheter Trays ROBOTIC PACK - 242561 Model No. MHRB88AO
Kits contain manufacturer-recalled perineal care (pericare) wipes within urinary catheter trays, which may be contaminated with a lubricant used during the manufacturing process. Use of a contaminated wipe may lead to localized skin effects such as irritation, erythema, or mild inflammation. Failure to perform pericare due to disposal of contaminated wipes may increase risk of localized infection or catheter-associated urinary tract infection (CAUTI).
- 2026-09-24Open, ClassifiedNonconforming Material/Component
Medline Convenience Kits: 1) MAJOR PACK, Catalog Number: DYNJ81325A
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.
- 2026-09-16Open, ClassifiedUnder Investigation by firm
Convenience kits MINOR PACK DYNJ58421A SPRINGHILL MINOR PACK DYNJ40734F
Kits may exhibit open seals in sterile pouch packaging. Open seal may compromise product sterility. If not detected prior to use, issue may lead to contamination of sterile field or patient infection if product is used.
- 2026-09-03Open, ClassifiedProcess change control
Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays: 1) KIT,GYN LAPAROSCOPY DH , Catalog Number: PBOCGLN17
The Urinary Catheter Trays contain CliniClean Pericare Wipes which may potentially be contaminated with a lubricant used during the manufacturing process. If a contaminated wipe is used on a patient, localized skin effects may occur. These may include irritation, erythema, or mild inflammation.
- 2026-08-31Open, ClassifiedNonconforming Material/Component
Medline Convenience Kits: 1) COLORECTAL ME, Model Number: DYNJ906437D
The kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a potential breach of sterility in the packaging, due to wrinkles in the paper lidding which may extend to the seal area. If the sterile barrier is compromised, patients and users may be exposed to microbial contamination. Potential health consequences may include no injury, localized infection, or, less commonly, more serious infection requiring medical treatment, antimicrobial therapy, procedural intervention, or hospitalization. In rare cases, particularly in critically ill or immunocompromised patients, severe infection could become life-threatening.
- 2026-08-26Open, ClassifiedProcess change control
Medline convenience kits labeled as: 1) MAJOR PROCEDURE, Medline Kit SKU CDS982040U; 2) OPERATIVE LAP P&S SURGICAL, Medline Kit SKU DYNJ89608; 3) LAPAROSCOPY, Medline Kit SKU DYNJ903479L; 4) LAPAROSCOPY, Medline Kit SKU DYNJ903479M.
Kits contain a potentially contaminated component which were recalled by the manufacturer
- 2026-06-25Open, ClassifiedNo Marketing Application
Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. BARIATRIC DYNJ905153J DYNJ905153K DYNJ905153L GYNE LAPAROTOMY PACK-LF DYNJ49593A LAPAROSCOPY DYNJ905157G DYNJ905157I DYNJ905157J LAPAROSCOPY PACK DYNJ56930B MAJOR PLUS PACK DYNJ905160J DYNJ905160K DYNJ905160M MINIMALLY INVASIVE PACK-LF DYNJ0843063K PERCUTANEOUS TRAY DYNJ80196 ROBOTIC PACK DYNJ908706 DYNJ908706B
Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601.
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DeviceWatch monitors available FDA adverse events and recalls. Growth includes event alerts for Death and Injury reports; Compliance Pro adds safety signals for investigation. FDA publication delays and incomplete collection or analysis coverage limit detection; no signal does not establish the absence of a safety concern. AI summaries and signals are provisional and require human review.