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.
device · product 1 of 2
Volcano R100 Sterile Equipment Cover; Sterile; General Hospital: These Sterile Equipment covers are provided to cover equipment that is mean to be used in the sterile surgical field but cannot be sterilized. The sterile drapes are put over this equipment in case any sterile items may come into contact with them.
Volcano Corporation has identified that certain lot numbers of Volcano R-100 Sterile Equipment Covers may have the incorrect expiry date on the outer shipping box; individually wrapped inner product bears the correct expiry date.
These labels are deterministic app interpretations, not FDA categories.
Volcano Corporation has identified that certain lot numbers of Volcano R-100 Sterile Equipment Covers may have the incorrect expiry date on the outer shipping box; individually wrapped inner product bears the correct expiry date.
Code information
REF numbers: PBKGB and PBKBG-10 (10 pack): all lots
Distribution pattern
Distributed US (nationwide) and the countries of Australia, South Africa, Canada, New Zealand, Belgium, Japan, and Paraguay.
device · product 2 of 2
Volcano SpinVision Sterile Equip cover II; Sterile; General Hospital: These Sterile Equipment covers are provided to cover equipment that is mean to be used in the sterile surgical field but cannot be sterilized. The sterile drapes are put over this equipment in case any sterile items may come into contact with them.
Volcano Corporation has identified that certain lot numbers of Volcano R-100 Sterile Equipment Covers may have the incorrect expiry date on the outer shipping box; individually wrapped inner product bears the correct expiry date.
These labels are deterministic app interpretations, not FDA categories.
Volcano Corporation has identified that certain lot numbers of Volcano R-100 Sterile Equipment Covers may have the incorrect expiry date on the outer shipping box; individually wrapped inner product bears the correct expiry date.
Code information
REF numbers: 891BG and 891BG-10 (10 pack): all lots
Distribution pattern
Distributed US (nationwide) and the countries of Australia, South Africa, Canada, New Zealand, Belgium, Japan, and Paraguay.
