CooperSurgical, Inc
53 recalls on record · Latest: Jul 30, 2025
FDA Devices Moderate Jul 30, 2025
Endosee System Convenience Kit with IV Tube. Model Number: ES-TRAY-IV. Endosee System Convenience Kit with IV Tube.
FDA Devices Moderate Dec 25, 2024
Brand Name: K-Systems Product Name: G85 Mini Incubator Model/Catalog Number: K22074 Software Version: N/A Product Description: An electrically-po…
FDA Devices Moderate Dec 25, 2024
Brand Name: K-Systems Product Name: T47 Warming Plate Model/Catalog Number: K23054 Software Version: N/A Product Description: An electrically-pow…
FDA Devices Moderate Dec 25, 2024
Brand Name: K-Systems Product Name: Multiple/unknown Model/Catalog Number: Multiple/unknown Software Version: N/A Product Description: An electri…
FDA Devices Moderate Dec 25, 2024
Brand Name: K-Systems Product Name: G73 Dry Bath Incubator Model/Catalog Number: K22065 Product Description: An electrically-powered device intend…
FDA Devices Moderate Oct 2, 2024
Stainless Steel Sims Uterine Sound, Part Number 64-601
FDA Devices Moderate Oct 2, 2024
Origio Sperm Wash Medium Pack of Five 60ml bottles - Intended for washing of spermatozoa. Part Number: 84055060D
FDA Devices Moderate Feb 14, 2024
Box as labeled: Regard, Carter-Thomason CloseSure System XL, REF 733776, Quantity 1 Box of 3 Systems. Kit as labeled: Regard, Carter-Thomason CloseS…
FDA Devices Moderate Dec 13, 2023
Cooper Surgical H/S ELLIPTOSPHERE CATH 5 Fr -For administering contrast media during Hysterosalpingography or Hysterosonography procedures to detect …
FDA Devices Moderate Dec 13, 2023
Cooper Surgical H/S ELLIPTOSPHERE CATH 5 FR Set-For administering contrast media during Hysterosalpingography or Hysterosonography procedures to dete…
FDA Devices Moderate Dec 13, 2023
CooperSurgical H/S CATHETER SET FR 5 with Integated Stylet Model: 61-4005S For administering contrast media during Hysterosalpingography or Hystero…
FDA Devices Moderate Apr 12, 2023
Global Total LP single step medium, 60mL, bicarbonate-buffered media for D1-5 embryo culture and transfer, Reference Number H5GT-060
FDA Devices Moderate Feb 8, 2023
BIOPSY MEDIUM 10ML, Reference Number 10620010 A, used for blastomere biopsy of cleavage stage embryos for Pre-implantation Genetic Diagnosis (PGD)
FDA Devices Moderate Nov 16, 2022
NEO-fit Neonatal Endotracheal Tube Grip, Part Number 42-2540
FDA Devices Moderate Oct 5, 2022
Humidifier bottle and syringe filter kit (6 count of each) for the BT37 Mark II Benchtop Incubator (AY200246)
FDA Devices Moderate Oct 5, 2022
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 produ…
FDA Devices Moderate Jul 27, 2022
LifeGlobal Fast Freeze Thawing Kit, Model No. GFT5-055
FDA Drug Critical Feb 23, 2022
PARAGARD T380A (intrauterine copper contraceptive), 1 unit per carton together with an insertion tube and solid white rod in a Tyvek polyethylene pou…
FDA Devices Moderate Nov 24, 2021
Quantum 2000 Electrosurgical Generators Cooper Surgical Part Number: 909075
FDA Devices Moderate Nov 24, 2021
LEEP PRECISION Integrated System, 220V CooperSurgical part numbers: LP-10-220
FDA Devices Moderate Nov 24, 2021
Quantum 2000 Electrosurgical Generators Cooper Surgical Part Number: 909075-05W
FDA Devices Moderate Nov 24, 2021
LEEP PRECISION Generator 220V Cooper Surgical Part Number: LP-20-220
FDA Devices Moderate Nov 24, 2021
LEEP PRECISION Integrated System, 120V CooperSurgical part number: LP-10-120
FDA Devices Moderate Jun 16, 2021
CooperSurgical Wallach Loop Electrode 10mm x 10mm Square P/N: 909131. Disposable Universal Electrodes, LOOP electrodes, used for electro-excisional…
FDA Devices Moderate Jun 2, 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 nat…
FDA Devices Moderate Jul 15, 2020
COOPERSURGICAL Os FinderTM Cervical Dilator, Taper: 2.0 mm to 4.0 mm OD Length: 21.5 cm Box of 50 Part Number: 1176
FDA Devices Moderate Jun 3, 2020
CooperSurgical Dilator/Sound Set, Rx only, Sterile/EO, Made in South Korea, P/N MX21
FDA Devices Moderate Jan 22, 2020
ADVANCED ENDOSEE System CANNULA, Cooper Surgical Product Code/Model Number: ESPX5 The Advanced Endosee Cannula (CooperSurgical Product Code: ESPX5…
FDA Devices Moderate Dec 11, 2019
Quantam 2000 Electrosurgical Generator, Part number 909075-05W.
FDA Devices Moderate Dec 11, 2019
Quantam 2000 Electrosurgical Generator, Part number 909075.
FDA Devices Low Oct 9, 2019
Embryology Heated Plate within the RI Witness, Model Numbers 6-70-807, 6-70-807-A, & 6-70-807-B - Product Usage: RI Witness uses Radio Frequency Iden…
FDA Devices Low Sep 25, 2019
LEEP Return Patient Pads (10/ box) Model # 6050Pl used in electrosurgical procedures.
FDA Devices Moderate Sep 4, 2019
TransWarmer Warming Infant Transport Mattress, Model no. 20421 Product Usage: The TransWarmer¿ Warming Infant Transport Mattress is gel-filled, …
FDA Devices Moderate Jul 31, 2019
LEEP Precision Integrated System 120V & LEEP Precision Generator, Model Nos. LP-10-120 & LP-20-120
FDA Devices Moderate Jul 24, 2019
Advincula Delineator with Ultem Plastic Soft Cup size 3.0 cm; Part No. AD750SC-KE30 The Advincula Delineator Uterine Manipulator is a single-use d…
FDA Devices Moderate Jul 24, 2019
Advincula Delineator with Ultem Plastic Soft Cup size 2.5 cm; Part No. AD750SC-KE25 The Advincula Delineator Uterine Manipulator is a single-use d…
FDA Devices Moderate Jun 26, 2019
LEEP Precision Integrated System 120V, Model LP-10-120 Product Usage: The LEEP PRECISION INTEGRATED SYSTEM l 20V combines three components - LEEP…
FDA Devices Moderate Oct 17, 2018
Colpo-Pneumo Occluder, Part CPO-6
FDA Devices Moderate Oct 3, 2018
Retractor System Elastic Stays (Part 3314-lG; 3316-lG; 3550-lG) Product Usage: The Retractor System Elastic Stays (Part 3314-lG; 3316-lG; 3550-lG…
FDA Devices Low Sep 28, 2016
Sage In-Vitro Fertilization- CSC (Choline Substituted Cryopreservation) Freezing Medium . Product Number: ART -8017 SAGE In Vitro Fertilization, In…
FDA Devices Low Sep 28, 2016
Sage In-Vitro Fertilization- CSC (Choline Substituted Cryopreservation) Thawing Medium Product Number: ART-8018 Intended for use in freezing embry…
FDA Devices Moderate Mar 16, 2016
Milex Arcing Diaphragm Size 95; Model Number: MXWS95
FDA Devices Low Oct 14, 2015
CooperSurgical LEEP REDIKIT-Used as a surgical preparatory kit for Loop Electrosurgical Excision Procedure P/N 6061
FDA Devices Moderate Jul 29, 2015
Milex Vaginal-Hymenal Silicone Dilators Set of 4 P/N MX20 Product Usage: The CooperSurgical Milex Vaginal-Hymenal Silicone Dilators are used f…
FDA Devices Moderate Jul 1, 2015
McKesson Medi-Pak Vaginal Speculum, 10/bag Reorder No. 11-8309 Used to expose interior of the vagina to facilitate visualization during gynecologic…
FDA Devices Moderate Mar 25, 2015
MediChoice WarmGel Infant Heel Warmer, Item # 1643069911 MediChoice Liquid Infant Heel Warmer, Item # 1643069912 Single Use and Disposable. Dis…
FDA Devices Moderate Mar 25, 2015
CooperSurgical Infant Heel Gel Warmers, P/N 20418 CooperSurgical The Infant Heal Warmer, P/N 2440 To provide gentle heat to increase blood flow a…
FDA Devices Moderate Mar 25, 2015
Fisher Brand Gel Infant Heel Gel Warmers, Cat. No.: 22-024647 Fisher Brand Liquid Infant Heel Warmer, Cat. No: 22-024646 To provide gentle heat …
FDA Devices Low Dec 10, 2014
Cooper Surgical CANNULA-CURETTE 12MM; Model Number: MX562 The CooperSurgical SUCTION CANNULA-CURETTE device is used to remove tissue from within t…
FDA Devices Low Nov 19, 2014