CooperSurgical, Inc.
CooperSurgical, Inc. appears in FDA public data with 84 recalls — including 1 Class I (most serious) —, 41 510(k) clearances, 25 FDA inspections, and 2 compliance actions on record. Its most recent recall (Z-2135-2025, Class II) was initiated on June 11, 2025. Its most recent 510(k) clearance was granted on August 29, 2025.
Summary
- Total Recalls
- 84 (1 Class I)
- 510(k) Clearances
- 41
- Inspections
- 25
- Compliance Actions
- 2
Known Names
coopersurgical, coopersurgical inc
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| Z-2135-2025 | Class II | HSG Procedure Tray. Model Number: 6050T. The HSG Procedure Tray is for use in hysterosalpingogra | June 11, 2025 |
| Z-2137-2025 | Class II | Endosee System Convenience Kit with IV Tube. Model Number: ES-TRAY-IV. Endosee System Convenience | June 11, 2025 |
| Z-2136-2025 | Class II | Endosee System Convenience Kit. Model Number: ES-TRAY. Endosee System Convenience Kit | June 11, 2025 |
| Z-0688-2025 | Class II | Brand Name: K-Systems Product Name: G85 Mini Incubator Model/Catalog Number: K22074 Software Vers | November 15, 2024 |
| Z-0692-2025 | Class II | Brand Name: K-Systems Product Name: Multiple/unknown Model/Catalog Number: Multiple/unknown Softw | November 15, 2024 |
| Z-0690-2025 | Class II | Brand Name: K-Systems Product Name: T47 Warming Plate Model/Catalog Number: K23055 Software Versi | November 15, 2024 |
| Z-0689-2025 | Class II | Brand Name: K-Systems Product Name: T47 Warming Plate Model/Catalog Number: K23054 Software Versi | November 15, 2024 |
| Z-0691-2025 | Class II | Brand Name: K-Systems Product Name: R65 Trolley Model/Catalog Number: K24012 Software Version: N/ | November 15, 2024 |
| Z-0687-2025 | Class II | Brand Name: K-Systems Product Name: G73 Dry Bath Incubator Model/Catalog Number: K22065 Product D | November 15, 2024 |
| Z-3189-2024 | Class II | Stainless Steel Sims Uterine Sound, Part Number 64-601 | July 31, 2024 |
| Z-3188-2024 | Class II | Silver-Plated Copper Sims Uterine Sound, Part Number 64-600 | July 31, 2024 |
| Z-3298-2024 | Class II | Origio Sperm Wash Medium Pack of Five 60ml bottles - Intended for washing of spermatozoa. Part Nu | February 16, 2024 |
| Z-3297-2024 | Class II | Origio Sperm Wash Medium Pack of Five 60ml bottles - Intended for washing of spermatozoa. Part Nu | February 16, 2024 |
| Z-3296-2024 | Class II | Origio Sperm Wash Medium Pack of Ten 10ml bottles - Intended for washing of spermatozoa Part Numb | February 16, 2024 |
| Z-1089-2024 | Class II | global Medium, Model Numbers LGGG-020 (20mL bottle), LGGG-050 (50mL bottle), LGGG-100 (100mL bottle) | December 20, 2023 |
| Z-0985-2024 | Class II | Box as labeled: Regard, Carter-Thomason CloseSure System XL, REF 733776, Quantity 1 Box of 3 Systems | August 29, 2023 |
| Z-1348-2023 | Class II | Global Total LP single step medium, 60mL, bicarbonate-buffered media for D1-5 embryo culture and tra | February 13, 2023 |
| Z-1044-2023 | Class II | BIOPSY MEDIUM 10ML, Reference Number 10620010 A, used for blastomere biopsy of cleavage stage embryo | December 15, 2022 |
| Z-0223-2023 | Class II | NEO-fit Neonatal Endotracheal Tube Grip, Part Number 42-2540 | October 20, 2022 |
| Z-1823-2022 | Class II | Humidifier bottle and syringe filter kit (6 count of each) for the BT37 Mark II Benchtop Incubator | August 12, 2022 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|---|---|
| K243799 | Fetal Pillow | August 29, 2025 |
| K250438 | CooperSurgical Milex® Pessaries | April 11, 2025 |
| K223064 | ALLY II Uterine Positioning System (UPS) | October 28, 2022 |
| K201086 | Advincula Delineator Uterine Manipulator | May 21, 2020 |
| K200038 | Endosee System | February 5, 2020 |
| K191020 | G210 InviCell Plus with SignipHy pH monitoring | January 14, 2020 |
| K191291 | Wallace Dual Lumen Oocyte Recovery System | June 12, 2019 |
| K190639 | Endosee System | May 15, 2019 |
| K182959 | Wallace Dual Lumen Oocyte Recovery System | May 10, 2019 |
| K183020 | Endosee System | January 31, 2019 |
| K180429 | Advincula Delineator Uterine Manipulator | March 14, 2018 |
| K173731 | SAGE Vitrification Kit (ART-8025 and ART-8026) / SAGE Vitrification Warming Kit (ART-8030 and ART-80 | March 2, 2018 |
| K170660 | Endosee Hysteroscope with Disposable Diagnostic (Dx) Cannula | July 13, 2017 |
| K170560 | SAGE Vitrification Kit and SAGE Vitrification Warming Kit | April 4, 2017 |
| K151845 | Infant Heel Warmer (Model 24401) and WarmGel Infant Heel Warmer (Model 20418) | March 18, 2016 |
| K153092 | Ally Uterine Positioning System | December 21, 2015 |
| K143650 | CooperSurgical Advincula Delineator Uterine Manipulator | July 21, 2015 |
| K143415 | Air Bubble Based Infuser (ABBI) | February 26, 2015 |
| K141523 | ALLY UPS | November 25, 2014 |
| K140754 | COOPER SURGICAL LEISEGANG COLPOSCOPE SYSTEM | October 23, 2014 |