Overview of recall records associated with CooperSurgical, Inc., including dates, categories and classifications where available.
Classification mix: Class II: 47, Class III: 5, Class I: 3.
Potential to exhibit a loose connection between the flexible tubing and the nasal cannula, during assembly or while in use, which may result in loss of CPAP pressure, possibly reducing the…
Potential to exhibit a loose connection between the flexible tubing and the nasal cannula, during assembly or while in use, which may result in loss of CPAP pressure, possibly reducing the…
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.
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.
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.
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…
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…
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…
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…
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…
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…
The firm has become aware of a sudden increase in complaints for three associated lots. Performance issues may lead to impaired embryo development prior to the blastocyst stage.
Incorrect component descriptions within the "Contents" section on the Tyvek lid for individual kit trays.
Incorrect bonding material used for assembly of the catheter, may fail, resulting in detachment of component parts, broken components, or leakage. This breakage may result in delay of…
Incorrect bonding material used for assembly of the catheter, may fail, resulting in detachment of component parts, broken components, or leakage. This breakage may result in delay of…
Incorrect bonding material used for assembly of the catheter, may fail, resulting in detachment of component parts, broken components, or leakage. This breakage may result in delay of…
It has come to CooperSurgical's attention that the affected Product may contain a medium other than the Global Total LP single step medium which does not contain the protein source required…
The affected product may contain a medium other than the Biopsy Medium. There is a risk that use of the Product from this lot could cause degradation of the embryo.
Firm has received 11 complaints involving a loose or detached metal clips, including 3 cases where the metal clip was ingested by the patient, and 3 cases where the metal clip was removed…
There is a potential breach to the sterile barrier containing the Humidifier Bottles due to the packaging of the filter box located inside the bottle packaging. Damage to the sterile…
There is a potential breach to the sterile barrier containing the Humidifier Bottles due to the packaging of the filter box located inside the bottle packaging. Damage to the sterile…
There was translation error in the Spanish version of the IFU where the Spanish version instructs the user to leave the blastocyte to air thaw for 5 minutes rather than the correct 5…
Products in this lot may have compromised barrier seals, introducing a risk to sterility.
Non-sterility
This page summarizes recall records in which the official source identifies CooperSurgical, Inc. as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.
