openFDA Device Enforcement
Report-date coverage
June 20, 2012–July 08, 2026
Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
openFDA Device Recall
event_date_initiated coverage
June 01, 1997–June 30, 2026
Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.
Product dates, classifications, firms, and source wording remain attached to their individual rows.
Opening this dossier never hides products that did not match a prior timeline filter.
The firm is issuing validated, new reprocessing instructions according to the FDA 2015 guidance, "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling."
These labels are deterministic app interpretations, not FDA categories.
The firm is issuing validated, new reprocessing instructions according to the FDA 2015 guidance, "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling."
Code information
All serial numbers
Distribution pattern
Domestic distribution nationwide. Product also distributed globally.
The firm is issuing validated, new reprocessing instructions according to the FDA 2015 guidance, "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling."
These labels are deterministic app interpretations, not FDA categories.
The firm is issuing validated, new reprocessing instructions according to the FDA 2015 guidance, "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling."
Code information
All serial numbers
Distribution pattern
Domestic distribution nationwide. Product also distributed globally.
The firm is issuing validated, new reprocessing instructions according to the FDA 2015 guidance, "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling."
These labels are deterministic app interpretations, not FDA categories.
The firm is issuing validated, new reprocessing instructions according to the FDA 2015 guidance, "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling."
Code information
All serial numbers
Distribution pattern
Domestic distribution nationwide. Product also distributed globally.
The firm is issuing validated, new reprocessing instructions according to the FDA 2015 guidance, "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling."
These labels are deterministic app interpretations, not FDA categories.
The firm is issuing validated, new reprocessing instructions according to the FDA 2015 guidance, "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling."
Code information
All serial numbers
Distribution pattern
Domestic distribution nationwide. Product also distributed globally.
The firm is issuing validated, new reprocessing instructions according to the FDA 2015 guidance, "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling."
These labels are deterministic app interpretations, not FDA categories.
The firm is issuing validated, new reprocessing instructions according to the FDA 2015 guidance, "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling."
Code information
All serial numbers
Distribution pattern
Domestic distribution nationwide. Product also distributed globally.
device · product 6 of 10
BF-XP160F EVIS EXERA Bronchovideoscope, Model No. BF-XP160F
The firm is issuing validated, new reprocessing instructions according to the FDA 2015 guidance, "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling."
These labels are deterministic app interpretations, not FDA categories.
The firm is issuing validated, new reprocessing instructions according to the FDA 2015 guidance, "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling."
Code information
All serial numbers
Distribution pattern
Domestic distribution nationwide. Product also distributed globally.
device · product 7 of 10
BF-XT160 EVIS EXERA Bronchovideoscope, Model No. BF-XT160
The firm is issuing validated, new reprocessing instructions according to the FDA 2015 guidance, "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling."
These labels are deterministic app interpretations, not FDA categories.
The firm is issuing validated, new reprocessing instructions according to the FDA 2015 guidance, "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling."
Code information
All serial numbers
Distribution pattern
Domestic distribution nationwide. Product also distributed globally.
device · product 8 of 10
BF-P180 EVIS EXERA II Bronchovideoscope, Model No. BF-P180
The firm is issuing validated, new reprocessing instructions according to the FDA 2015 guidance, "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling."
These labels are deterministic app interpretations, not FDA categories.
The firm is issuing validated, new reprocessing instructions according to the FDA 2015 guidance, "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling."
Code information
All serial numbers
Distribution pattern
Domestic distribution nationwide. Product also distributed globally.
device · product 9 of 10
BF-1T180 EVIS EXERA II Bronchovideoscope, Model No. BF-1T180
The firm is issuing validated, new reprocessing instructions according to the FDA 2015 guidance, "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling."
These labels are deterministic app interpretations, not FDA categories.
The firm is issuing validated, new reprocessing instructions according to the FDA 2015 guidance, "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling."
Code information
All serial numbers
Distribution pattern
Domestic distribution nationwide. Product also distributed globally.
device · product 10 of 10
BF-Q180-AC EVIS EXERA II Bronchovideoscope, Model No. BF-Q180-AC
The firm is issuing validated, new reprocessing instructions according to the FDA 2015 guidance, "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling."
These labels are deterministic app interpretations, not FDA categories.
The firm is issuing validated, new reprocessing instructions according to the FDA 2015 guidance, "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling."
Code information
All serial numbers
Distribution pattern
Domestic distribution nationwide. Product also distributed globally.
