Coopersurgical, Inc.
95 CORPORATE DRIVE, Trumbull, CT, US
Registered product codes
97 product codes
Recent MDR events
2,456 on file
- LEEP PRECISION GENERATORJul 30, 2026Malfunction1216677-2026-00075
- CooperSurgicalJul 30, 2026Malfunction1216677-2026-00079
- CooperSurgicalJul 30, 2026Malfunction1216677-2026-00080
- CooperSurgicalJul 30, 2026Malfunction1216677-2026-00077
- CooperSurgicalJul 30, 2026Malfunction1216677-2026-00081
- CooperSurgicalJul 30, 2026Malfunction1216677-2026-00078
- CooperSurgicalJul 29, 2026Malfunction1216677-2026-00073
- CooperSurgicalJul 29, 2026Malfunction1216677-2026-00074
- CooperSurgicalJul 27, 2026Malfunction1216677-2026-00072
- COOPERSURGICALJul 21, 2026Malfunction1216677-2026-00070
Recalls
86 on file
- Open, ClassifiedJul 18, 2025
The HSG Procedure Trays and Endosee System Convenience Kits contain non-sterile iodine pouches, however the peel away lid labels incorrectly identify the iodine pouches as sterile.
View FDA record ↗ - Open, ClassifiedJul 18, 2025
The HSG Procedure Trays and Endosee System Convenience Kits contain non-sterile iodine pouches, however the peel away lid labels incorrectly identify the iodine pouches as sterile.
View FDA record ↗ - Open, ClassifiedJul 18, 2025
The HSG Procedure Trays and Endosee System Convenience Kits contain non-sterile iodine pouches, however the peel away lid labels incorrectly identify the iodine pouches as sterile.
View FDA record ↗ - Open, ClassifiedDec 18, 2024
The warming surfaces or incubator well temperatures of the listed products may exceed the desired set temperature. If temperatures exceed the desired set value, the device will alarm appropriately.
View FDA record ↗ - Open, ClassifiedDec 18, 2024
The warming surfaces or incubator well temperatures of the listed products may exceed the desired set temperature. If temperatures exceed the desired set value, the device will alarm appropriately.
View FDA record ↗ - Open, ClassifiedDec 18, 2024
The warming surfaces or incubator well temperatures of the listed products may exceed the desired set temperature. If temperatures exceed the desired set value, the device will alarm appropriately.
View FDA record ↗ - Open, ClassifiedDec 18, 2024
The warming surfaces or incubator well temperatures of the listed products may exceed the desired set temperature. If temperatures exceed the desired set value, the device will alarm appropriately.
View FDA record ↗ - Open, ClassifiedDec 18, 2024
The warming surfaces or incubator well temperatures of the listed products may exceed the desired set temperature. If temperatures exceed the desired set value, the device will alarm appropriately.
View FDA record ↗ - Open, ClassifiedDec 18, 2024
The warming surfaces or incubator well temperatures of the listed products may exceed the desired set temperature. If temperatures exceed the desired set value, the device will alarm appropriately.
View FDA record ↗ - Open, ClassifiedSep 26, 2024
Low concentration of sodium pyruvate in the wash could compromise gamete development
View FDA record ↗
Compliance history
Matched by FEI 1216677.
FDA inspections
0 on file
No inspections on file for this FEI number.
Inspection citations
0 on file
No citations on file for this FEI number.
Compliance actions
0 on file
No warning letters or injunctions on file for this FEI number.
Import refusals
0 on file
No import refusals on file for this FEI number.