34 results
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25ms
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Sources: EU EUDAMED, US FDA
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Status: Open, Classified
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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