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CooperSurgical, Inc.

51 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
HSG Procedure Tray. Model Number: 6050T. The HSG Procedure Tray is for use in hysterosalpi recall (Z-2135-2025)CooperSurgical, Inc.2025-07-18
Endosee System Convenience Kit. Model Number: ES-TRAY. Endosee System Convenience Kit recall (Z-2136-2025)CooperSurgical, Inc.2025-07-18
Endosee System Convenience Kit with IV Tube. Model Number: ES-TRAY-IV. Endosee System Conv recall (Z-2137-2025)CooperSurgical, Inc.2025-07-18
Brand Name: K-Systems Product Name: G73 Dry Bath Incubator Model/Catalog Number: K22065 Pr recall (Z-0687-2025)CooperSurgical, Inc.2024-12-18
Brand Name: K-Systems Product Name: G85 Mini Incubator Model/Catalog Number: K22074 Softwa recall (Z-0688-2025)CooperSurgical, Inc.2024-12-18
Brand Name: K-Systems Product Name: T47 Warming Plate Model/Catalog Number: K23054 Softwar recall (Z-0689-2025)CooperSurgical, Inc.2024-12-18
Brand Name: K-Systems Product Name: T47 Warming Plate Model/Catalog Number: K23055 Softwar recall (Z-0690-2025)CooperSurgical, Inc.2024-12-18
Brand Name: K-Systems Product Name: R65 Trolley Model/Catalog Number: K24012 Software Vers recall (Z-0691-2025)CooperSurgical, Inc.2024-12-18
Brand Name: K-Systems Product Name: Multiple/unknown Model/Catalog Number: Multiple/unknow recall (Z-0692-2025)CooperSurgical, Inc.2024-12-18
Origio Sperm Wash Medium Pack of Ten 10ml bottles - Intended for washing of spermatozoa Pa recall (Z-3296-2024)CooperSurgical, Inc.2024-09-26
Origio Sperm Wash Medium Pack of Five 60ml bottles - Intended for washing of spermatozoa. recall (Z-3297-2024)CooperSurgical, Inc.2024-09-26
Origio Sperm Wash Medium Pack of Five 60ml bottles - Intended for washing of spermatozoa. recall (Z-3298-2024)CooperSurgical, Inc.2024-09-26
Silver-Plated Copper Sims Uterine Sound, Part Number 64-600 recall (Z-3188-2024)CooperSurgical, Inc.2024-09-20
Stainless Steel Sims Uterine Sound, Part Number 64-601 recall (Z-3189-2024)CooperSurgical, Inc.2024-09-20
global Medium, Model Numbers LGGG-020 (20mL bottle), LGGG-050 (50mL bottle), LGGG-100 (100 recall (Z-1089-2024)CooperSurgical, Inc.2024-02-14
Box as labeled: Regard, Carter-Thomason CloseSure System XL, REF 733776, Quantity 1 Box of recall (Z-0985-2024)CooperSurgical, Inc.2024-02-05
Cooper Surgical H/S ELLIPTOSPHERE CATH 5 Fr -For administering contrast media during Hyste recall (Z-0502-2024)CooperSurgical, Inc.2023-12-06
Cooper Surgical H/S ELLIPTOSPHERE CATH 5 FR Set-For administering contrast media during Hy recall (Z-0503-2024)CooperSurgical, Inc.2023-12-06
CooperSurgical H/S CATHETER SET FR 5 with Integated Stylet Model: 61-4005S For administeri recall (Z-0504-2024)CooperSurgical, Inc.2023-12-06
Global Total LP single step medium, 60mL, bicarbonate-buffered media for D1-5 embryo cultu recall (Z-1348-2023)CooperSurgical, Inc.2023-04-06
BIOPSY MEDIUM 10ML, Reference Number 10620010 A, used for blastomere biopsy of cleavage st recall (Z-1044-2023)CooperSurgical, Inc.2023-01-31
NEO-fit Neonatal Endotracheal Tube Grip, Part Number 42-2540 recall (Z-0223-2023)CooperSurgical, Inc.2022-11-10
Humidifier bottle and syringe filter kit (6 count of each) for the BT37 Mark I Benchtop In recall (Z-1822-2022)CooperSurgical, Inc.2022-09-28
Humidifier bottle and syringe filter kit (6 count of each) for the BT37 Mark II Benchtop I recall (Z-1823-2022)CooperSurgical, Inc.2022-09-28
Milex Gellhorn Flexible under the following labels: 1) Gellhorn Flexible w/Short Stem Pess recall (Z-1152-2021)CooperSurgical, Inc.2021-02-26
Sage In-Vitro Fertilization- CSC (Choline Substituted Cryopreservation) Freezing Medium . recall (Z-2850-2016)CooperSurgical, Inc.2016-09-20
Sage In-Vitro Fertilization- CSC (Choline Substituted Cryopreservation) Thawing Medium Pro recall (Z-2851-2016)CooperSurgical, Inc.2016-09-20
Milex Arcing Diaphragm Size 95; Model Number: MXWS95 recall (Z-1054-2016)CooperSurgical, Inc.2016-03-04
MILEX PESSARY KIT; Model Numbers: MXPES00; MXKPES00; MXKPREG03; MXKPGSK07 Product Usage: T recall (Z-0253-2016)CooperSurgical, Inc.2015-11-10
CooperSurgical LEEP REDIKIT-Used as a surgical preparatory kit for Loop Electrosurgical Ex recall (Z-0105-2016)CooperSurgical, Inc.2015-10-06
Infant Heel Warmer and Infant Gel Warmer, sold under the brand names CooperSurgical and Fi recall (Z-2147-2015)CooperSurgical, Inc.2015-07-20
Milex Vaginal-Hymenal Silicone Dilators Set of 4 P/N MX20 Product Usage: The CooperSurgica recall (Z-2098-2015)CooperSurgical, Inc.2015-07-17
McKesson Medi-Pak Vaginal Speculum, 10/bag Reorder No. 11-8309 Used to expose interior of recall (Z-1824-2015)CooperSurgical, Inc.2015-06-22
MILEX OMNIFLEX DIAPHRAGM SIZE 80 Model: MXWF80 recall (Z-1814-2015)CooperSurgical, Inc.2015-06-18
Ally Uterine Positioning System (Ally UPS) used in the mounting and positioning and holdin recall (Z-1727-2015)CooperSurgical, Inc.2015-06-08
Carter-Thomason II Port Closure System; Model Number(s) CTI-1015P, for use in endoscopic a recall (Z-1630-2015)CooperSurgical, Inc.2015-05-19
WALLACH LL 100 cryosurgical units: LL100 Cryosurgical - Part Number 900001; LL110 with Pin recall (Z-1450-2015)CooperSurgical, Inc.2015-04-16
CooperSurgical TransWarmer Infant Transport Mattress with WarmGel P/N 20421 Private label: recall (Z-1397-2015)CooperSurgical, Inc.2015-04-07
CooperSurgical Infant Heel Gel Warmers, P/N 20418 CooperSurgical The Infant Heal Warmer, P recall (Z-1298-2015)CooperSurgical, Inc.2015-03-19
Fisher Brand Gel Infant Heel Gel Warmers, Cat. No.: 22-024647 Fisher Brand Liquid Infant H recall (Z-1299-2015)CooperSurgical, Inc.2015-03-19
MediChoice WarmGel Infant Heel Warmer, Item # 1643069911 MediChoice Liquid Infant Heel War recall (Z-1300-2015)CooperSurgical, Inc.2015-03-19
NovaPlus Brand Warm Gel Infant Heel Gel Warmer, Item # V6391 NovaPlus Brand Liquid Heal Wa recall (Z-1301-2015)CooperSurgical, Inc.2015-03-19
CooperSurgical PESSARY KIT-CUBE#2, 1-3/8 in , 35 mm Part Number: MXKPEC02 recall (Z-1239-2015)CooperSurgical, Inc.2015-03-03
CooperSurgical LEEP RADIUS LOOP ELECTRODE (W 2.0 cm x D 1.0 cm D, 12 cm shaft ). Box of 5 recall (Z-0484-2015)CooperSurgical, Inc.2014-12-02
Cooper Surgical CANNULA-CURETTE 12MM; Model Number: MX562 The CooperSurgical SUCTION CANNU recall (Z-0488-2015)CooperSurgical, Inc.2014-12-01
CooperSurgical MILEX PESSARY KITS-Ring w/Support Folding Pessary- #1 Model: MXKPRS01 Produ recall (Z-0207-2015)CooperSurgical, Inc.2014-11-13
CooperSurgical MILEX PESSARY KITS- Hodge w/Support Folding Pessary- #1 Model: MXKPHS01 Pro recall (Z-0208-2015)CooperSurgical, Inc.2014-11-13
CooperSurgical H/S CATHETER (PART # 61-5007) Intended for Hysterosonography/ Hysterosalpin recall (Z-2570-2014)CooperSurgical, Inc.2014-09-05
Cooper Surgical TAMPA CATHETER 5 French 33 cm. Intended for Hysterosonography. Model Numbe recall (Z-1782-2014)CooperSurgical, Inc.2014-06-11
Milex 60cc Handy-Vak Locking Syringe Ref: MX500 recall (Z-0401-06)CooperSurgical, Inc.2006-01-18
Mystic M-Style Mushroom Cup Mityvac Vacuum Assisted Delivery System Product No: 10047 recall (Z-0005-05)CooperSurgical, Inc.2004-10-05

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