CooperSurgical, Inc.

FDA Regulatory Profile

Summary

Total Recalls
84 (1 Class I)
510(k) Clearances
41
Inspections
24
Compliance Actions
2

Recent Recalls

NumberClassProductDate
Z-2137-2025Class IIEndosee System Convenience Kit with IV Tube. Model Number: ES-TRAY-IV. Endosee System ConvenienceJune 11, 2025
Z-2136-2025Class IIEndosee System Convenience Kit. Model Number: ES-TRAY. Endosee System Convenience KitJune 11, 2025
Z-2135-2025Class IIHSG Procedure Tray. Model Number: 6050T. The HSG Procedure Tray is for use in hysterosalpingograJune 11, 2025
Z-0690-2025Class IIBrand Name: K-Systems Product Name: T47 Warming Plate Model/Catalog Number: K23055 Software VersiNovember 15, 2024
Z-0688-2025Class IIBrand Name: K-Systems Product Name: G85 Mini Incubator Model/Catalog Number: K22074 Software VersNovember 15, 2024
Z-0689-2025Class IIBrand Name: K-Systems Product Name: T47 Warming Plate Model/Catalog Number: K23054 Software VersiNovember 15, 2024
Z-0691-2025Class IIBrand Name: K-Systems Product Name: R65 Trolley Model/Catalog Number: K24012 Software Version: N/November 15, 2024
Z-0692-2025Class IIBrand Name: K-Systems Product Name: Multiple/unknown Model/Catalog Number: Multiple/unknown SoftwNovember 15, 2024
Z-0687-2025Class IIBrand Name: K-Systems Product Name: G73 Dry Bath Incubator Model/Catalog Number: K22065 Product DNovember 15, 2024
Z-3188-2024Class IISilver-Plated Copper Sims Uterine Sound, Part Number 64-600July 31, 2024
Z-3189-2024Class IIStainless Steel Sims Uterine Sound, Part Number 64-601July 31, 2024
Z-3298-2024Class IIOrigio Sperm Wash Medium Pack of Five 60ml bottles - Intended for washing of spermatozoa. Part NuFebruary 16, 2024
Z-3297-2024Class IIOrigio Sperm Wash Medium Pack of Five 60ml bottles - Intended for washing of spermatozoa. Part NuFebruary 16, 2024
Z-3296-2024Class IIOrigio Sperm Wash Medium Pack of Ten 10ml bottles - Intended for washing of spermatozoa Part NumbFebruary 16, 2024
Z-1089-2024Class IIglobal Medium, Model Numbers LGGG-020 (20mL bottle), LGGG-050 (50mL bottle), LGGG-100 (100mL bottle)December 20, 2023
Z-0985-2024Class IIBox as labeled: Regard, Carter-Thomason CloseSure System XL, REF 733776, Quantity 1 Box of 3 SystemsAugust 29, 2023
Z-1348-2023Class IIGlobal Total LP single step medium, 60mL, bicarbonate-buffered media for D1-5 embryo culture and traFebruary 13, 2023
Z-1044-2023Class IIBIOPSY MEDIUM 10ML, Reference Number 10620010 A, used for blastomere biopsy of cleavage stage embryoDecember 15, 2022
Z-0223-2023Class IINEO-fit Neonatal Endotracheal Tube Grip, Part Number 42-2540October 20, 2022
Z-1822-2022Class IIHumidifier bottle and syringe filter kit (6 count of each) for the BT37 Mark I Benchtop Incubator (August 12, 2022

Recent 510(k) Clearances

K-NumberDeviceDate
K243799Fetal PillowAugust 29, 2025
K250438CooperSurgical Milex® PessariesApril 11, 2025
K223064ALLY II Uterine Positioning System™ (UPS)October 28, 2022
K201086Advincula Delineator Uterine ManipulatorMay 21, 2020
K200038Endosee SystemFebruary 5, 2020
K191020G210 InviCell Plus with SignipHy pH monitoringJanuary 14, 2020
K191291Wallace Dual Lumen Oocyte Recovery SystemJune 12, 2019
K190639Endosee SystemMay 15, 2019
K182959Wallace Dual Lumen Oocyte Recovery SystemMay 10, 2019
K183020Endosee SystemJanuary 31, 2019
K180429Advincula Delineator Uterine ManipulatorMarch 14, 2018
K173731SAGE Vitrification Kit (ART-8025 and ART-8026) / SAGE Vitrification Warming Kit (ART-8030 and ART-80March 2, 2018
K170660Endosee Hysteroscope with Disposable Diagnostic (Dx) CannulaJuly 13, 2017
K170560SAGE Vitrification Kit and SAGE Vitrification Warming KitApril 4, 2017
K151845Infant Heel Warmer (Model 24401) and WarmGel Infant Heel Warmer (Model 20418)March 18, 2016
K153092Ally Uterine Positioning SystemDecember 21, 2015
K143650CooperSurgical Advincula Delineator Uterine ManipulatorJuly 21, 2015
K143415Air Bubble Based Infuser (ABBI)February 26, 2015
K141523ALLY UPSNovember 25, 2014
K140754COOPER SURGICAL LEISEGANG COLPOSCOPE SYSTEMOctober 23, 2014