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 3
Heating Profile PRISMAFLO II S blood return warmer for Prismaflex Product Code: PF2-WP33 Product Usage: The PRISMAFLO IIS warmer is used for warming return blood flow.
PRISMAFLO II and PRISMAFLO II S Heating Profile only and not the Control Unit, damage may result in a hotspot on the Heating Profile, may cause low level skin burn
These labels are deterministic app interpretations, not FDA categories.
PRISMAFLO II and PRISMAFLO II S Heating Profile only and not the Control Unit, damage may result in a hotspot on the Heating Profile, may cause low level skin burn
Code information
Serial Numbers: E22000 to E23999
Distribution pattern
Worldwide Distribution - US Nationwide in the states of CA and Foreign of: Switzerland
device · product 2 of 3
Heating Profile PRISMAFLO II S blood return warmer for Prismaflex Product Code: PF2-WP31 Product Usage: The PRISMAFLO IIS warmer is used for warming return blood flow.
PRISMAFLO II and PRISMAFLO II S Heating Profile only and not the Control Unit, damage may result in a hotspot on the Heating Profile, may cause low level skin burn
These labels are deterministic app interpretations, not FDA categories.
PRISMAFLO II and PRISMAFLO II S Heating Profile only and not the Control Unit, damage may result in a hotspot on the Heating Profile, may cause low level skin burn
Code information
Serial Numbers: E22368
Distribution pattern
Worldwide Distribution - US Nationwide in the states of CA and Foreign of: Switzerland
device · product 3 of 3
Heating Profile PRISMAFLO II blood return warmer for Prismaflex Product Code: PF2-WP2618 Product Usage: The PRISMAFLO IIS warmer is used for warming return blood flow.
PRISMAFLO II and PRISMAFLO II S Heating Profile only and not the Control Unit, damage may result in a hotspot on the Heating Profile, may cause low level skin burn
These labels are deterministic app interpretations, not FDA categories.
PRISMAFLO II and PRISMAFLO II S Heating Profile only and not the Control Unit, damage may result in a hotspot on the Heating Profile, may cause low level skin burn
Code information
Serial Numbers: UH07154 to UH07479
Distribution pattern
Worldwide Distribution - US Nationwide in the states of CA and Foreign of: Switzerland
