Gynecological Laparoscopic Kit
FDA product code OHD · Class II (moderate risk) · 21 CFR 884.1720 · 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
54recalls
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-3101-2026 Class II | Presource 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, LLC | 07/29/2026Open, Classified |
| Z-3025-2026 Class II | Medline convenience kits labeled as: 1) GYN ROBOTIC CDS, Medline Kit SKU CDS982888Q; 2)…Kits contain a potentially contaminated component which were recalled by the manufacturer | Medline Industries, LP | 07/10/2026Open, Classified |
| Z-2786-2026 Class II | Medline convenience kits containing Bard Silastic Foley Catheters (French sizes 16, 18…Affected kits contain recalled Bard Silastic Foley Catheters. Catheters were recalled by manufacturer due to… | Medline Industries, LP | 06/08/2026Open, Classified |
| Z-2785-2026 Class II | Medline convenience kits containing Bard Silastic Foley Catheters (French sizes 16, 18…Affected kits contain recalled Bard Silastic Foley Catheters. Catheters were recalled by manufacturer due to… | Medline Industries, LP | 06/08/2026Open, Classified |
| Z-2784-2026 Class II | Medline convenience kits containing Bard Silastic Foley Catheters (French sizes 16, 18…Affected kits contain recalled Bard Silastic Foley Catheters. Catheters were recalled by manufacturer due to… | Medline Industries, LP | 06/08/2026Open, Classified |
| Z-2783-2026 Class II | Medline convenience kits containing Bard Silastic Foley Catheters (French sizes 16, 18…Affected kits contain recalled Bard Silastic Foley Catheters. Catheters were recalled by manufacturer due to… | Medline Industries, LP | 06/08/2026Open, Classified |
| Z-2782-2026 Class II | Medline convenience kits containing Bard Silastic Foley Catheters (French sizes 16, 18…Affected kits contain recalled Bard Silastic Foley Catheters. Catheters were recalled by manufacturer due to… | Medline Industries, LP | 06/08/2026Open, Classified |
| Z-2780-2026 Class II | Medline convenience kits containing Bard Silastic Foley Catheters (French sizes 16, 18…Affected kits contain recalled Bard Silastic Foley Catheters. Catheters were recalled by manufacturer due to… | Medline Industries, LP | 06/08/2026Open, Classified |
| Z-2503-2026 Class II | MEDLINE Medical Procedure Kits labeled as BASIC GYN, CW LAP GYN, D&C HYSTEROSCOPY, CW…During an internal review, Medline identified representative samples did not meet applicable performance… | Medline Industries, LP | 05/04/2026Open, Classified |
| Z-2431-2026 Class II | Medline convenience kits: DAVINCI DYNJ905836D DAVINCI-LF DYNJ905293I GENERAL ROBOTICS…Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack… | Medline Industries, LP | 04/27/2026Open, Classified |
| Z-2034-2026 Class II | Medline 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, LP | 03/19/2026Open, Classified |
| Z-1885-2026 Class II | Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes…Unapproved design changes to the products outside of the 510(k) clearance. | Medline Industries, LP | 02/27/2026Open, Classified |
| Z-1728-2026 Class I | Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA)…Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe… | Medline Industries, LP | 02/27/2026Open, Classified |
| Z-1846-2026 Class II | Medline Kits: 1) GYN LAPAROSCOPY PACK, Model Number: DYNJ41257FThe 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have… | Medline Industries, LP | 02/25/2026Open, Classified |
| Z-2109-2026 Class II | See full list in RES, exceeds character limit 1) GYN LAPAROSCOPY CDS, Model Number:…Medline has identified issues related to calibration of the equipment used to sterilize and package the… | Medline Industries, LP | 01/07/2026Open, Classified |
| Z-1415-2026 Class II | Medline Convenience Kits: 1) ROBOTIC GYN CDS-1, Model Number: CDS982893I; 2) GYN…Medline has identified issues related to calibration of the equipment used to sterilize and package the… | Medline Industries, LP | 01/07/2026Open, Classified |
| Z-1088-2026 Class II | Medline medical procedure convenience kits labeled as: 1) ROBOTIC, REF CDS980523M; 2)…Medline kits containing Stryker's Strykeflow 2 Suction Irrigators due to a change in design in 2024… | Medline Industries, LP | 12/16/2025Open, Classified |
| Z-1197-2026 Class II | Medline medical procedure convenience kits labeled as: 1) RR-GYN LAPAROSCOPY PACK-LF…Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was recalled due to… | Medline Industries, LP | 12/12/2025Open, Classified |
| Z-0450-2026 Class I | Convenience kits; DYNJ901046M GYN ROBOTIC DYNJ909120D ROBOTIC PROSTATEFirm received multiple complaints of anesthesia circuit leaks due to cracks in the 120" expandable tubing.… | Medline Industries, LP | 10/10/2025Open, Classified |
| Z-0524-2026 Class II | MEDLINE convenience kits labeled as: 1) GYN LAPAROSCOPY CDS #34-RF, REF CDS920099S; 2)…Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing… | Medline Industries, LP | 09/30/2025Open, Classified |
| Z-0179-2026 Class II | Medical convenience kits Item Number/Description RCGY52D GYN LAPAROSCOPY SPH 0246965…Identified products were re-gassed (sterilized more than once) after a nonconformance occurred during the… | American Contract Systems Inc. | 09/04/2025Open, Classified |
| Z-2470-2025 Class II | AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) LAPAROSCOPY…During an internal investigation, ACS determined that the rationale for sterilization of certain components… | American Contract Systems Inc | 07/14/2025Open, Classified |
| Z-1613-2025 Class II | Medline Convenience kits used for various procedures: 1) STANDARD D&C, Model Number:…There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile… | MEDLINE INDUSTRIES, LP - Northfield | 03/03/2025Open, Classified |
| Z-1369-2025 Class II | Proxima Drape labeled as UNIVERSAL DAVINCI ROBOTIC P. Sterile surgical drape.Potential breach in pouch packaging which could lead to loss of sterility. | MEDLINE INDUSTRIES, LP - Northfield | 02/13/2025Open, Classified |
| Z-1447-2025 Class II | Medline procedure kits labeled as: 1) CLOVIS ROBOTIC-LF, Pack Number DYNJ61061D; 2)…Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024.… | MEDLINE INDUSTRIES, LP - Northfield | 02/11/2025Open, Classified |
| Z-0792-2025 Class II | Medline custom medical procedure kits labeled as: 1) ENSEMBLE RACHIS-LF, REF DYNJ47568B…Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties & Surgical… | MEDLINE INDUSTRIES, LP - Northfield | 11/21/2024Open, Classified |
| Z-0914-2025 Class II | Cardinal Health Presource Kits: 1 ) KIT, FETAL SURGERY, Catalog Number PB11FSC10 2 )…Potential endotoxin contamination in non-sterile surgical strips and patties in Presource kits. | Cardinal Health 200, LLC | 11/08/2024Open, Classified |
| Z-0725-2025 Class II | KIT,SPINE LH Convenience kit, SKU DYNJ906448A.Surgical Patties & Surgical Strips in specific lots of Custom Convenience Kits were found to contain… | MEDLINE INDUSTRIES, LP - Northfield | 11/06/2024Open, Classified |
| Z-0643-2025 Class II | MEDLINE convenience kits labeled as: 1) GYN LAPAROSCOPY-LF, REF CDS760059I; 2) GYN…Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil… | MEDLINE INDUSTRIES, LP - Northfield | 10/09/2024Open, Classified |
| Z-0175-2025 Class II | Medline brand medical procedure convenience kits, labeled as: a) LITHOTOMY PACK, REF…It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may… | MEDLINE INDUSTRIES, LP - Northfield | 09/04/2024Open, Classified |
| Z-3233-2024 Class II | Bilateral Tubal Ligation Pack, FHBT3T; Medical convenience kitACS identified that due to an inoperable chart recorder, humidity readings were out-of-specification in one… | American Contract Systems, Inc. | 08/07/2024Open, Classified |
| Z-3118-2024 Class II | Medline convenience kits containing semi-rigid suction liners labeled as follows: MTHZ…Due to reported adverse events, Medline Industries, LP. is issuing a recall on specific SKUs and lots of… | MEDLINE INDUSTRIES, LP - Northfield | 06/27/2024Open, Classified |
| Z-2518-2024 Class II | American Contract Systems Gyn Laparoscopy convenience kitProduct released with insufficient aeration time impacting the kits sterilized on the same cycle or in the… | American Contract Systems, Inc. | 05/06/2024Open, Classified |
| Z-3046-2024 Class II | Medline Convenience kits labeled as: 1) LAVH CDS, Pack Number CDS760049AB; 2) TUBAL…Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024.… | MEDLINE INDUSTRIES, LP - Northfield | 04/08/2024Open, Classified |
| Z-2712-2024 Class II | Medline medical procedure kits labeled as follows: a) GYN CDS, REF DYNJ905499B; b) GYN…A slight dimensional variation which has the potential for increased difficulty fitting into outer canister. | MEDLINE INDUSTRIES, LP - Northfield | 03/22/2024Open, Classified |
| Z-0828-2024 Class II | Custom 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-1123-2024 Class I | Medline Kits, trays, and packs labeled as follows: a) GYN LAPAROSCOPY, REF CDS984900M…Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of… | MEDLINE INDUSTRIES, LP - Northfield | 11/15/2023Open, Classified |
| Z-2188-2023 Class II | Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following:…Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams. | MEDLINE INDUSTRIES, LP - Northfield | 05/18/2023Open, Classified |
| Z-2333-2023 Class II | Custom 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 - Northfield | 05/15/2023Open, Classified |
| Z-1690-2023 Class II | Presource Kit, SMA21LPUHJ GYN Laparoscopy Pack. Convenience kit used for Laparoscopic…Inadvertently released for distibution without sterility assurance. | Cardinal Health 200, LLC | 04/06/2023Open, Classified |
| Z-1435-2023 Class II | Sterile surgical convenience kit: regard Item Number: 800753005, GY00958E - WPH GYN…The recalling firm was notified by their supplier that the light handle covers may separate from the light… | ROi CPS LLC | 03/22/2023Open, Classified |
| Z-1091-2023 Class II | Sterile Procedural Trays, labeled as the following: a. GYN-URO LAPSCP CDS-LF b. ROBOTIC…Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the… | MEDLINE INDUSTRIES, LP - Northfield | 11/17/2022Open, Classified |
| Z-1702-2022 Class II | Various hysterectomy, vaginal packsProduct was exposed to multiple sterilization cycles without validation for multiple exposures. | American Contract Systems, Inc. | 06/16/2022Open, Classified |
| Z-1491-2021 Class II | UpsylonTM Y Mesh Kit with Colpassist Vaginal Positioning Device - Product Usage:…Potential for pinholes (sterile barrier breach) on the edge of the pouch to potentially render the device… | Boston Scientific Corporation | 04/15/2021Open, Classified |
| Z-1473-2016 Class II | Catalog Number: 900486 LAPAROSCOPY SURGICAL PACK Used by medical staff to perform…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… | Customed, Inc | 01/07/2016Terminated |
| Z-1472-2016 Class II | Catalog Number: 900484 LAPAROSCOPIC GYNECOLOGY SURGICAL PACK Used by medical staff to…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… | Customed, Inc | 01/07/2016Terminated |
| Z-2604-2015 Class II | O.B. PACK 4/CS REV. Used by medical staff to perform surgical procedures and patient…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… | Customed, Inc | 07/10/2015Terminated |
| Z-2571-2015 Class II | LAPAROSC. OB GYN PK 5/CS Used by medical staff to perform surgical procedures and…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… | Customed, Inc | 07/10/2015Terminated |
| Z-2564-2015 Class II | PERY GYN PACK CUSTOMED 10/CS Used by medical staff to perform surgical procedures and…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… | Customed, Inc | 07/10/2015Terminated |
| Z-2562-2015 Class II | PERI GYN PACK CS/6 Used by medical staff to perform surgical procedures and patient care…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… | Customed, Inc | 07/10/2015Terminated |