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Hysterectomy Kit

FDA product code OJF · Class 2 · Obstetrics/Gynecology

5,511
Registered devices
35
Adverse events
30
Recalls
0
510(k) clearances

Devices with this code

CARDINAL HEALTH — Cardinal Health 200, LLCMedline Industries, Inc. — MEDLINE INDUSTRIES, INC.Medline Industries, Inc. — MEDLINE INDUSTRIES, INC.ACS — AMERICAN CONTRACT SYSTEMS, INC.CARDINAL 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, LLCCARDINAL HEALTH — Cardinal Health 200, LLCMedline 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.ACS — AMERICAN CONTRACT SYSTEMS, INC.Medline Industries, Inc. — MEDLINE INDUSTRIES, INC.CARDINAL HEALTH — Cardinal Health 200, LLCMedline Industries, Inc. — MEDLINE INDUSTRIES, INC.Medline Industries, Inc. — MEDLINE INDUSTRIES, INC.CARDINAL HEALTH — Cardinal Health 200, LLCCARDINAL HEALTH — Cardinal Health 200, LLCMedline Industries, Inc. — MEDLINE INDUSTRIES, INC.CARDINAL HEALTH — Cardinal Health 200, LLC

Recent recalls

DateFirmReason
2026-08-31Medline Industries, LPKits contain CONMED AirSeal Access Ports. The ports were recalled by manufacturer due to potential for erroneous overpressure alerts and system venting during u
2026-08-18Cardinal Health 200, LLCThe 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 tha
2026-08-10American Contract Systems IncKits contain manufacturer-recalled perineal care (pericare) wipes within urinary catheter trays, which may be contaminated with a lubricant used during the manu
2026-07-29Cardinal Health 200, LLCThe Urinary Catheter Trays contain CliniClean Pericare Wipes which may potentially be contaminated with a lubricant used during the manufacturing process. If a
2026-07-10Medline Industries, LPKits contain a potentially contaminated component which were recalled by the manufacturer
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
2026-04-27Medline 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, LPUnapproved design changes to the products outside of the 510(k) clearance.

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