Overview of recall records associated with Cook Inc., including dates, categories and classifications where available.
Classification mix: Class II: 203, Class I: 33.
Cap-adapter assembly of the device may potentially not be adequately tightened, possibly leading to fluid leakage from or air aspiration into the connecting tube.
Cap-adapter assembly of the device may potentially not be adequately tightened, possibly leading to fluid leakage from or air aspiration into the connecting tube.
Cap-adapter assembly of the device may potentially not be adequately tightened, possibly leading to fluid leakage from or air aspiration into the connecting tube.
Cap-adapter assembly of the device may potentially not be adequately tightened, possibly leading to fluid leakage from or air aspiration into the connecting tube.
The interior of the product may not be sterilized to the appropriate Sterility Assurance Level when following the reprocessing instructions in the Instructions for Use.
The interior of the product may not be sterilized to the appropriate Sterility Assurance Level when following the reprocessing instructions in the Instructions for Use.
The interior of the product may not be sterilized to the appropriate Sterility Assurance Level when following the reprocessing instructions in the Instructions for Use.
The interior of the product may not be sterilized to the appropriate Sterility Assurance Level when following the reprocessing instructions in the Instructions for Use.
The interior of the product may not be sterilized to the appropriate Sterility Assurance Level when following the reprocessing instructions in the Instructions for Use.
The interior of the product may not be sterilized to the appropriate Sterility Assurance Level when following the reprocessing instructions in the Instructions for Use.
The interior of the product may not be sterilized to the appropriate Sterility Assurance Level when following the reprocessing instructions in the Instructions for Use.
Incorrect product labeling. Product labeled as 6mm x 2cm balloon are packaged with a 4mm x 4 cm balloon label and vice-versa.
Pump was found to be constructed from crimp connectors that do not meet the fixation wiring requirements and can cause failure of the device to operate or electric shock or burn to the user.
The temperature of the incubation lids of the MINC Bench top Incubators may become too high or too low for proper gamete/embryo incubation due to fatigue failure of the flat flex lid heater.
The temperature of the incubation lids of the MINC Bench top Incubators may become too high or too low for proper gamete/embryo incubation due to fatigue failure of the flat flex lid heater.
Pump was found to be constructed from crimp connectors that do not meet the fixation wiring requirements and can cause failure of the device to operate or electric shock or burn to the user.
Certain lots of in vitro fertilization (IVF) products were distributed without completed finished device quality testing with potential adverse events that may include nonviable gametes…
Certain lots of in vitro fertilization (IVF) products were distributed without completed finished device quality testing with potential adverse events that may include nonviable gametes…
Certain lots of in vitro fertilization (IVF) products were distributed without completed finished device quality testing with potential adverse events that may include nonviable gametes…
Certain lots of in vitro fertilization (IVF) products were distributed without completed finished device quality testing with potential adverse events that may include nonviable gametes…
This page summarizes recall records in which the official source identifies Cook 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.
