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Laparoscopy Kit

FDA product code FDE · Class 2 · Gastroenterology, Urology

33,808
Registered devices
256
Adverse events
120
Recalls
4
510(k) clearances

Devices with this code

CARDINAL HEALTH — Cardinal Health 200, LLCMedline Industries, Inc. — MEDLINE INDUSTRIES, INC.CARDINAL HEALTH — Cardinal Health 200, LLCCARDINAL HEALTH — Cardinal Health 200, LLCMedline Industries, Inc. — MEDLINE INDUSTRIES, INC.Medline Industries, Inc. — MEDLINE INDUSTRIES, INC.Medline Industries, Inc. — MEDLINE INDUSTRIES, INC.CARDINAL HEALTH — Cardinal Health 200, LLCMedline Industries, Inc. — MEDLINE INDUSTRIES, INC.Medline Industries, Inc. — MEDLINE INDUSTRIES, INC.Medline Industries, Inc. — MEDLINE INDUSTRIES, INC.Medline Industries, Inc. — MEDLINE INDUSTRIES, INC.Medline Industries, Inc. — MEDLINE INDUSTRIES, INC.Medline Industries, Inc. — MEDLINE INDUSTRIES, INC.CARDINAL HEALTH — Cardinal Health 200, LLCCARDINAL HEALTH — Cardinal Health 200, LLCCARDINAL HEALTH — Cardinal Health 200, LLCMedline Industries, Inc. — MEDLINE INDUSTRIES, INC.Medline Industries, Inc. — MEDLINE INDUSTRIES, INC.Medline Industries, Inc. — MEDLINE INDUSTRIES, INC.Medline Industries, Inc. — MEDLINE INDUSTRIES, INC.Medline Industries, Inc. — MEDLINE INDUSTRIES, INC.Medline Industries, Inc. — MEDLINE INDUSTRIES, INC.Medline Industries, Inc. — MEDLINE INDUSTRIES, INC.

Recent recalls

DateFirmReason
2026-07-10Medline Industries, LPKits contain a potentially contaminated component which were recalled by the manufacturer
2026-06-12Medline Industries, LPThe 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 t
2026-05-04Medline Industries, LPDuring an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularitie
2026-04-27Medline Industries, LPKits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for applicat
2026-03-19Medline Industries, LPDuring an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market
2026-02-27Medline Industries, LPFirm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601.
2026-02-27Medline Industries, LPMedline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during use, which may result i
2026-02-27Medline Industries, LPUnapproved design changes to the products outside of the 510(k) clearance.
2026-02-25Medline Industries, LPThe 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.
2026-01-07Medline Industries, LPMedline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated ster

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.