34 results · 25ms · Sources: EU EUDAMED, US FDA

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LEEP PRECISION Integrated System, 120V CooperSurgical part number: LP-10-120

FDA Recall
Open, Classified ·CooperSurgical, Inc.·Product code HGI·September 29, 2021

Quantum 2000 Electrosurgical Generators Cooper Surgical Part Number: 909075

FDA Recall
Open, Classified ·CooperSurgical, Inc.·Product code HGI·September 29, 2021

LEEP PRECISION Generator 120V Cooper Surgical Part Number: LP-20-120

FDA Recall
Open, Classified ·CooperSurgical, Inc.·Product code HGI·September 29, 2021

Endosee System Convenience Kit. Model Number: ES-TRAY. Endosee System Convenience Kit

FDA Recall
Open, Classified ·CooperSurgical, Inc.·Product code HIB·June 11, 2025

HSG Procedure Tray. Model Number: 6050T. The HSG Procedure Tray is for use in hysterosalpingography and sonohysterography procedures.

FDA Recall
Open, Classified ·CooperSurgical, Inc.·Product code HIB·June 11, 2025

Humidifier bottle and syringe filter kit (6 count of each) for the BT37 Mark I Benchtop Incubator (AY102295). The Mark I model is no longer produced, but the legacy humidifier bottle component design can also be used with the BT37 Mark II Benchtop Incubator.

FDA Recall
Open, Classified ·CooperSurgical, Inc.·Product code MQG·August 12, 2022

CooperSurgical H/S CATHETER SET FR 5 with Integated Stylet Model: 61-4005S For administering contrast media during Hysterosalpingography or Hysterosonography procedures to detect uterine pathology such as polyps, fibroids, adhesions or endometrial thickening, and/or patency of fallopian tubes

FDA Recall
Open, Classified ·CooperSurgical, Inc.·Product code LKF·March 31, 2022

LEEP PRECISION Generator 220V Cooper Surgical Part Number: LP-20-220

FDA Recall
Open, Classified ·CooperSurgical, Inc.·Product code HGI·September 29, 2021

LifeGlobal Fast Freeze Thawing Kit, Model No. GFT5-055

FDA Recall
Open, Classified ·CooperSurgical, Inc.·Product code MQL·June 13, 2022

Silver-Plated Copper Sims Uterine Sound, Part Number 64-600

FDA Recall
Open, Classified ·CooperSurgical, Inc.·Product code HHM·July 31, 2024

Origio Sperm Wash Medium Pack of Five 60ml bottles - Intended for washing of spermatozoa. Part Number: 84055060A

FDA Recall
Open, Classified ·CooperSurgical, Inc.·Product code MQL·February 16, 2024

Brand Name: K-Systems Product Name: T47 Warming Plate Model/Catalog Number: K23054 Software Version: N/A Product Description: An electrically-powered device intended to provide suitable warming and/or incubation conditions for reproductive biological materials (e.g., gametes and embryos), at closely regulated and monitored temperatures, during assisted reproduction examination and processing procedures. It may support a more comprehensive growth environment [e.g., temperature, carbon dioxide (CO2) and oxygen (O2) concentration]; it typically has adjustment and monitoring controls. Component: No

FDA Recall
Open, Classified ·CooperSurgical, Inc.·Product code PUB·November 15, 2024

Brand Name: K-Systems Product Name: T47 Warming Plate Model/Catalog Number: K23055 Software Version: N/A Product Description: An electrically-powered device intended to provide suitable warming and/or incubation conditions for reproductive biological materials (e.g., gametes and embryos), at closely regulated and monitored temperatures, during assisted reproduction examination and processing procedures. It may support a more comprehensive growth environment [e.g., temperature, carbon dioxide (CO2) and oxygen (O2) concentration]; it typically has adjustment and monitoring controls. Component: No

FDA Recall
Open, Classified ·CooperSurgical, Inc.·Product code PUB·November 15, 2024

Stainless Steel Sims Uterine Sound, Part Number 64-601

FDA Recall
Open, Classified ·CooperSurgical, Inc.·Product code HHM·July 31, 2024

Origio Sperm Wash Medium Pack of Five 60ml bottles - Intended for washing of spermatozoa. Part Number: 84055060D

FDA Recall
Open, Classified ·CooperSurgical, Inc.·Product code MQL·February 16, 2024

Global Total LP single step medium, 60mL, bicarbonate-buffered media for D1-5 embryo culture and transfer, Reference Number H5GT-060

FDA Recall
Open, Classified ·CooperSurgical, Inc.·Product code MQL·February 13, 2023

Brand Name: K-Systems Product Name: G85 Mini Incubator Model/Catalog Number: K22074 Software Version: N/A Product Description: An electrically-powered device intended to provide suitable warming and/or incubation conditions for reproductive biological materials (e.g., gametes and embryos), at closely regulated and monitored temperatures, during assisted reproduction examination and processing procedures. It may support a more comprehensive growth environment [e.g., temperature, carbon dioxide (CO2) and oxygen (O2) concentration]; it typically has adjustment and monitoring controls. Component: No

FDA Recall
Open, Classified ·CooperSurgical, Inc.·Product code PUB·November 15, 2024

Quantum 2000 Electrosurgical Generators Cooper Surgical Part Number: 909075-05

FDA Recall
Open, Classified ·CooperSurgical, Inc.·Product code HGI·September 29, 2021

The Ultem Polymeric Resin Koh Cup is a non- sterile, reusable vaginal fornices delineator. It is made of medical grade plastics and not made with natural rubber latex. Model Number(s): KCP-30-2

FDA Recall
Open, Classified ·CooperSurgical, Inc.·Product code HEW·April 23, 2021

BIOPSY MEDIUM 10ML, Reference Number 10620010 A, used for blastomere biopsy of cleavage stage embryos for Pre-implantation Genetic Diagnosis (PGD)

FDA Recall
Open, Classified ·CooperSurgical, Inc.·Product code MQL·December 15, 2022