Hysterectomy Kit

FDA product code OJF · Class II (moderate risk) · 21 CFR 884.4530 · Obstetrics/Gynecology

This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.

0510(k) clearances
0PMA approvals
27recalls

Recalls

RecallProductFirmInitiated
Z-3103-2026 Class IIPresource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays:…The Urinary Catheter Trays contain CliniClean Pericare Wipes which may potentially be contaminated with a… Cardinal Health 200, LLC07/29/2026Open, Classified
Z-3027-2026 Class IIMedline convenience kits labeled as: 1) LAVH, Medline Kit SKU CDS982273U; 2) GYN…Kits contain a potentially contaminated component which were recalled by the manufacturer Medline Industries, LP07/10/2026Open, Classified
Z-2505-2026 Class IIMEDLINE Medical Procedure Kits labeled as CLOVIS HYSTEROSCOPY, CSC-N PELVISCOPY, D AND C…During an internal review, Medline identified representative samples did not meet applicable performance… Medline Industries, LP05/04/2026Open, Classified
Z-2447-2026 Class IIMedline convenience kits: HYSTERECTOMY PACK-LF DYNJ20485LKits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack… Medline Industries, LP04/27/2026Open, Classified
Z-2433-2026 Class IIMedline convenience kits: WT LAVH PACK DYNJ46609FKits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack… Medline Industries, LP04/27/2026Open, Classified
Z-2035-2026 Class IIMedline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1.…During an internal review, Medline identified higher-than-expected endotoxin levels on a representative… Medline Industries, LP03/19/2026Open, Classified
Z-1892-2026 Class IIMedline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes…Unapproved design changes to the products outside of the 510(k) clearance. Medline Industries, LP02/27/2026Open, Classified
Z-1847-2026 Class IIMedline Kits: 1) HYSTEROSCOPY PACK, Model Number: DYNJ48399C; 2) SLING PACK, Model…The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have… Medline Industries, LP02/25/2026Open, Classified
Z-2111-2026 Class IIMedline Convenience Kits: 1) HYSTEROSCOPY, Model Number: CDS984086I; 2) KIT GYN ONCOLOGY…Medline has identified issues related to calibration of the equipment used to sterilize and package the… Medline Industries, LP01/07/2026Open, Classified
Z-1418-2026 Class IIMedline Convenience Kits: 1) HYSTEROSCOPY, Model Number: CDS984086I; 2) KIT GYN ONCOLOGY…Medline has identified issues related to calibration of the equipment used to sterilize and package the… Medline Industries, LP01/07/2026Open, Classified
Z-1089-2026 Class IIMedline medical procedure convenience kits labeled as: 1) LAVH PROCEDURE, REF…Medline kits containing Stryker's Strykeflow 2 Suction Irrigators due to a change in design in 2024… Medline Industries, LP12/16/2025Open, Classified
Z-0527-2026 Class IIMEDLINE convenience kits labeled as: 1) GYN LAPAROTOMY HARPER PACK-LF, REF DYNJ0160684F…Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing… Medline Industries, LP09/30/2025Open, Classified
Z-2471-2025 Class IIAMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) ROBOT HYST…During an internal investigation, ACS determined that the rationale for sterilization of certain components… American Contract Systems Inc07/14/2025Open, Classified
Z-1615-2025 Class IIMedline Convenience kits used for various procedures: 1) PERI GYN PACK, Model Number:…There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile… MEDLINE INDUSTRIES, LP - Northfield03/03/2025Open, Classified
Z-1449-2025 Class IIMedline procedure kits labeled as: 1) CSMC/ABDOMINAL HYST PACK-LF, Pack Number…Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024.… MEDLINE INDUSTRIES, LP - Northfield02/11/2025Open, Classified
Z-1133-2025 Class IICardinal Health Presource Kits: 1) KIT,ROBOTIC HYSTERECTOMY, Catalog Number:PB4FRHWFA…Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits. Cardinal Health 200, LLC11/08/2024Open, Classified
Z-0646-2025 Class IIMEDLINE convenience kits labeled as: 1) MAJOR LITHOTOMY CDS-LF, REF CDS760056G; 2) LAVH…Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil… MEDLINE INDUSTRIES, LP - Northfield10/09/2024Open, Classified
Z-0176-2025 Class IIMedline brand medical procedure convenience kits, labeled as: a) ABDOMINAL HYSTERECTOMY…It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may… MEDLINE INDUSTRIES, LP - Northfield09/04/2024Open, Classified
Z-3049-2024 Class IIMedline Convenience kits labeled as: 1) OFFICE PACK FOR HYSTEROSCOPY, Pack Number…Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024.… MEDLINE INDUSTRIES, LP - Northfield04/08/2024Open, Classified
Z-2763-2024 Class IIMedline procedural kits labeled as: 1) LEEP PACK, Pack Number DYNJ40348G; 2) TRAB BUCKLE…Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024.… MEDLINE INDUSTRIES, LP - Northfield04/08/2024Open, Classified
Z-0831-2024 Class IICustom procedural convenience kits and trays, Obstetrical & Gynecological use, labeled…During an internal investigation, ACS identified that several components were "piggybacked" to ACS trays and… American Contract Systems, Inc.11/29/2023Open, Classified
Z-0172-2024 Class IILAVH, REF BBLV21CDuring an internal investigation, ACS identified that the components, I.V. Cath (part number 4252535-02) and… American Contract Systems, Inc.09/01/2023Open, Classified
Z-2196-2023 Class IIMedline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a)…Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams. MEDLINE INDUSTRIES, LP - Northfield05/18/2023Open, Classified
Z-2335-2023 Class IICustom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel.…Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications. MEDLINE INDUSTRIES, LP - Northfield05/15/2023Open, Classified
Z-1093-2023 Class IISterile Procedural Trays, labeled as the following: a. GYN ABD CDS b. LAVH PROCEDURE c.…Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the… MEDLINE INDUSTRIES, LP - Northfield11/17/2022Open, Classified
Z-0338-2015 Class ITotal Hysterectomy, catalog #900-2415 Used by medical staff to perform patient care…Significant compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the… Customed, Inc10/08/2014Terminated
Z-2454-2014 Class ITOTAL HYCTERECTOMY (I) CANNULA 5MM XCEL SLEEVES LIF ( I ) TROCAR XCEL BLADELESS II MM…Customed has determined that there is the possibility that packaging integrity may be compromised on… Customed, Inc05/20/2014Terminated