Obstetrical Kit
FDA product code OKV · Class II (moderate risk) · 21 CFR 884.4520 · 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
91recalls
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-3028-2026 Class II | Medline convenience kits labeled as: 1) CMH LITHO MINOR PACK-LF, Medline Kit SKU…Kits contain a potentially contaminated component which were recalled by the manufacturer | Medline Industries, LP | 07/10/2026Open, Classified |
| Z-2964-2026 Class II | Halyard LAVH PACK, Model/Catalog Number: USAR053-11A customer complaint reported that the Clearify Visualization System (5303907) leaked in a kit. As a result… | AVID Medical, Inc. | 07/10/2026Open, Classified |
| Z-2787-2026 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-2506-2026 Class II | MEDLINE Medical Procedure Kits labeled as: KIT URO ROBOT CYSTECTOMY, D AND C PACK, MAD D…During an internal review, Medline identified representative samples did not meet applicable performance… | Medline Industries, LP | 05/04/2026Open, Classified |
| Z-2434-2026 Class II | Medline convenience kits: DAVINCI MAIN DYNJ908031DKits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack… | Medline Industries, LP | 04/27/2026Open, Classified |
| Z-2036-2026 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-1848-2026 Class II | Medline Kits: 1) D AND C PACK, Model Number: DYNJ41254BThe 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have… | Medline Industries, LP | 02/25/2026Open, Classified |
| Z-2112-2026 Class II | Medline Convenience Kits: 1) BAP NORTH ROBOTIC SURGERY CDS, Model Number: CDS982407N; 2)…Medline has identified issues related to calibration of the equipment used to sterilize and package the… | Medline Industries, LP | 01/07/2026Open, Classified |
| Z-1419-2026 Class II | Medline Convenience Kits: 1) BAP NORTH ROBOTIC SURGERY CDS, Model Number: CDS982407N; 2)…Medline has identified issues related to calibration of the equipment used to sterilize and package the… | Medline Industries, LP | 01/07/2026Open, Classified |
| Z-1090-2026 Class II | Medline medical procedure convenience kits labeled as: KIT ROBOTICS UROLOGY PROSTATE…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-0528-2026 Class II | MEDLINE convenience kits labeled as: GP-LEEP PACK-LF, REF PHS396969004FMedline 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-2257-2025 Class II | LAVH PACK. Medical convenience kit.CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration. | AVID Medical, Inc. | 06/11/2025Open, Classified |
| Z-2251-2025 Class II | GYN ROBOTIC PACK. Medical convenience kit.CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration. | AVID Medical, Inc. | 06/11/2025Open, Classified |
| Z-2250-2025 Class II | GYN LAPAROSCOPY PACK. Medical convenience kit.CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration. | AVID Medical, Inc. | 06/11/2025Open, Classified |
| Z-2248-2025 Class II | GENERAL ROBOTIC PACK. Medical convenience kit.CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration. | AVID Medical, Inc. | 06/11/2025Open, Classified |
| Z-2242-2025 Class II | CT DAVINCI. Medical convenience kit.CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration. | AVID Medical, Inc. | 06/11/2025Open, Classified |
| Z-1616-2025 Class II | Medline Convenience kits used for various procedures: 1) UTHET TYLER OB PACK, Model…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-1450-2025 Class II | Medline procedure kits labeled as: 1) L S GYN PACK, Pack Number DYNJ65616C; 2) MAIN…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-0793-2025 Class II | Medline custom medical procedure kits labeled as: 1) CERVICAL PACK-LF, REF DYNJ0867145G…Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties & Surgical… | MEDLINE INDUSTRIES, LP - Northfield | 11/21/2024Open, Classified |
| Z-0647-2025 Class II | MEDLINE convenience kits labeled as: 1) TOT/ GYN LITHOTOMY CDS, REF CDS985431J; 2) TOT/…Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil… | MEDLINE INDUSTRIES, LP - Northfield | 10/09/2024Open, Classified |
| Z-0436-2025 Class II | Halyard GYN PAC - Medical convenience kits Model Number: SJGY20-02Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach from the… | AVID Medical, Inc. | 09/20/2024Open, Classified |
| Z-0435-2025 Class II | Halyard C SECTION PACK - Medical convenience kits Model Number: SJCS66-02Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach from the… | AVID Medical, Inc. | 09/20/2024Open, Classified |
| Z-0424-2025 Class II | Halyard MAJOR VAGINAL GYN PACK - Medical convenience kits Model Number: SAMM021-11Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach from the… | AVID Medical, Inc. | 09/20/2024Open, Classified |
| Z-0423-2025 Class II | Halyard LAPAROTOMY GYN PACK - Medical convenience kits Model Number: SAMM018-13Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach from the… | AVID Medical, Inc. | 09/20/2024Open, Classified |
| Z-0408-2025 Class II | Halyard POST PARTUM TUBAL LIGATION - Medical convenience kits Model Number: LANC026-19Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach from the… | AVID Medical, Inc. | 09/20/2024Open, Classified |
| Z-0407-2025 Class II | Halyard VAG HYSTERECTOMY BUNDLE PK - Medical convenience kits Model Number: LANC022-29Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach from the… | AVID Medical, Inc. | 09/20/2024Open, Classified |
| Z-0406-2025 Class II | Halyard C SECTION BUNDLE - Medical convenience kits Model Number: LANC015-34Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach from the… | AVID Medical, Inc. | 09/20/2024Open, Classified |
| Z-0405-2025 Class II | Halyard GYN TRAY - Medical convenience kits Model Number: LANC014-19Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach from the… | AVID Medical, Inc. | 09/20/2024Open, Classified |
| Z-0385-2025 Class II | Halyard D & C PACK-CKC - Medical convenience kits Model Number: BMGT003-02Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach from the… | AVID Medical, Inc. | 09/20/2024Open, Classified |
| Z-0177-2025 Class II | Medline brand medical procedure convenience kits, labeled as: a) OB PACK-LF, 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-0151-2025 Class II | Centurion OB TRAY, REF MNS13965A; medical procedure convenience kitIt 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-3050-2024 Class II | Medline Convenience kits labeled as: 1) LABOR & DELIVERY CDS, Pack Number CDS830039AD…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-1125-2024 Class I | Medline Kits, trays, and packs labeled as follows: a) D&C CDS, REF CDS983911J; b) D&C…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-2189-2023 Class II | Medline 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 - Northfield | 05/18/2023Open, Classified |
| Z-2336-2023 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-1094-2023 Class II | Sterile Procedural Trays, labeled as the following: a. CELEBRATION ROBOTIC CDS b.…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-1632-2022 Class II | MORRISON MEDICAL Morrison Medical OB KIT, HARD PK SEALED W/CARDBOARD BX MORMED Catalog…Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher… | Mckesson Medical-Surgical Inc. Corporate… | 05/25/2022Open, Classified |
| Z-1522-2020 Class II | Custom procedure trays containing medical components needed to facilitate patient…The medical procedure trays contain one or more recalled surgical gowns. The gowns were manufactured at… | Avid Medical, Inc. | 02/18/2020Terminated |
| Z-1865-2017 Class II | Vacutainer Tubes Vacutainer tubes are intended for clinical laboratory hematology…Avid Medical Inc has received a complaint was received from an end-user indicating the vacutainer component… | Avid Medical, Inc. | 03/15/2017Terminated |
| Z-1495-2016 Class II | Catalog Number: 900997 PERI-GYN SURGICAL PACK Used by medical staff to perform surgical…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… | Customed, Inc | 01/07/2016Terminated |
| Z-1478-2016 Class II | Catalog Number: 900548A PERY-GYN SURGICAL PACK Used by medical staff to perform surgical…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… | Customed, Inc | 01/07/2016Terminated |
| Z-1469-2016 Class II | Catalog Number: 900419 LABOR & DELIVERY 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-1464-2016 Class II | Catalog Number: 9002940 OBSTETRICAL 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-1419-2016 Class II | Catalog Number: 9001297 PREMIUM OBSTETRICAL 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-1399-2016 Class II | Catalog Number: 900012 OB SURGICAL PACK Used by medical staff to perform surgical…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… | Customed, Inc | 01/07/2016Terminated |
| Z-2716-2015 Class II | PERI GYN PACK 5/CS 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 |
| Z-2697-2015 Class II | O.B. PACK HOSPITAL 3/CS 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-2696-2015 Class II | PERI GYN PACK 5/CS 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 |
| Z-2687-2015 Class II | PERY-GYN SURGICAL PACK 6/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-2677-2015 Class II | LABOR & DELIVERY 4/CS 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 |