Boston Scientific HYDRATOME RX 44-20MM/450CM Material Number: M00583060 recall — FDA Z-0760-2022
Sterility of device is compromised due to a sterile barrier breach
Complete FDA and NHTSA recall records dated in March 2022.
These records include useful source details for the selected month.
Sterility of device is compromised due to a sterile barrier breach
Hazelnuts were declared in ingredient statement but not in Contains statement.
Undeclared wheat.
Undeclared allergen - egg
Undeclared wheat.
Undeclared wheat.
Undeclared wheat.
Undeclared wheat.
During manufacturing pieces of hard clear plastic was found. Upon investigation the source was identified as ice purchased from supplier.
Incorrect packaging for product resulting in an undeclared wheat allergen
During manufacturing pieces of hard clear plastic was found. Upon investigation the source was identified as ice purchased from supplier.
Undeclared almonds
During manufacturing pieces of hard clear plastic was found. Upon investigation the source was identified as ice purchased from supplier.
Product may be contaminated with Listeria monocytogenes.
During manufacturing pieces of hard clear plastic was found. Upon investigation the source was identified as ice purchased from supplier.
During manufacturing pieces of hard clear plastic was found. Upon investigation the source was identified as ice purchased from supplier.
Firm distributed Dried Salted Plum (Saladitos) that may contain high lead levels.
During manufacturing pieces of hard clear plastic was found. Upon investigation the source was identified as ice purchased from supplier.
Undeclared almonds
Firm distributed Dried Salted Plum (Saladitos) that may contain high lead levels.
During manufacturing pieces of hard clear plastic was found. Upon investigation the source was identified as ice purchased from supplier.
Dietary supplement may contain potential metal shavings greater than or equal to 7mm in length.
During manufacturing pieces of hard clear plastic was found. Upon investigation the source was identified as ice purchased from supplier.
During manufacturing pieces of hard clear plastic was found. Upon investigation the source was identified as ice purchased from supplier.
Use this page to compare the recalls reported during the month, then open an individual record for the exact reason, classification, company, remedy or distribution information available from the official source. Monthly counts are descriptive, not a safety rating.