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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 97466

2 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
August 18, 2025
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Boston Scientific Corporation

Dossier provenance

Source snapshots represented here

  • 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.

How coverage and grouping work

Complete imported group

Every recalled product in this event

2 official enforcement rows

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

ICEfx Cryoablation System, portable helium-free desktop cryoablation unit, Material Numbers (UPN) FPRCH8000, FPRCH8000-02, H749396118000

Z-2550-2025
Recall number
Z-2550-2025
Initiated
August 18, 2025
Classification
Class II
Status
Ongoing
Quantity
18 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Certain desiccant tube subassemblies were built with end caps that were not correctly tightened.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Certain desiccant tube subassemblies were built with end caps that were not correctly tightened.

Code information

FPRCH8000 UDI-DI: 00859019006370, Serial Numbers: ICP0305, ICP0369, ICP0338; FPRCH8000-02 UDI-DI: 00859019006417, Serial Numbers: 86643865, 108415728, 88589050, 108470986, 89392275, 108612524, 107799735, ICP0299, 107887794, 3779, 108254011, IF0096 108312221, 104733618; H749396118000 UDI-DI: 00191506014995, Serial Numbers: 106066356, 107851990

Distribution pattern

Worldwide - US Nationwide and the countries of Canada, France, Germany and Italy. (Preventive Maintenance Kit distributed to Canada only.)

device · product 2 of 2

Preventive Maintenance (PM) Kit ICEFX, Material Number (UPN) SPRPM8000

Z-2551-2025
Recall number
Z-2551-2025
Initiated
August 18, 2025
Classification
Class II
Status
Ongoing
Quantity
1 unit

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Certain desiccant tube subassemblies were built with end caps that were not correctly tightened.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Certain desiccant tube subassemblies were built with end caps that were not correctly tightened.

Code information

Batch: 108159110

Distribution pattern

Worldwide - US Nationwide and the countries of Canada, France, Germany and Italy. (Preventive Maintenance Kit distributed to Canada only.)