Boston Scientific JAGTOME REVOLUTION RX 39-20-260-025 Material Number: M00584240 recall — FDA Z-0765-2022
Sterility of device is compromised due to a sterile barrier breach
Complete FDA and NHTSA recall records dated in 2022, organized for browsing by month, category and recalling company.
Select a month to review the recall records reported during that period.
Records are ordered by the best available source date.
Sterility of device is compromised due to a sterile barrier breach
Sterility of device is compromised due to a sterile barrier breach
Sterility of device is compromised due to a sterile barrier breach
Firm discovered that an incorrect version of the Instructions for Use (IFU) containing language beyond the cleared 510(k) were inserted in the affected products. Firm is replacing these…
Sterility of device is compromised due to a sterile barrier breach
Sterility of device is compromised due to a sterile barrier breach
Due to partially assembled valved dressing that has a hole within it instead of the intended non-valved dressing in the package resulting in that the dressing cannot be centered over the…
Sterility of device is compromised due to a sterile barrier breach
LYFO Disk Catalog #0983L is to contain Candida tropicalis. However, lot number 983-40-3 under Catalog #0983L, labeled as Candida tropicalis, is actually Yersinia entercolitica. This…
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.
This archive groups records by their reported or recall date. It does not imply that every recall was initiated, announced and resolved during the same calendar year. Open the individual record for the exact dates and source details supplied by FDA or NHTSA.