Exact FDA event identifier

Event 96703

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

Event summary

Timeline bucket: April 17, 2025
Product types: Device
Classifications: Class II
Statuses: Ongoing
Recalling firm wording: Cook Incorporated

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

Check=Flo Performer Introducer, 10.0Fr, Reference Part Number(RPN) REF RCFW-10.0-0-38-30-RB, Order Number (GPN) REF G08686,

Z-1786-2025

Recall number: Z-1786-2025
Initiated: April 17, 2025
Classification: Class II
Status: Ongoing
Recalling firm: Cook Incorporated
Quantity: 99 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Cook Medical identified that devices from the affected device lots may contain the incorrectly sized introducer sheath.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Cook Medical identified that devices from the affected device lots may contain the incorrectly sized introducer sheath.

Code information

UDI/DI 00827002086869, Lot Number 16376248

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Belgium, Germany, Spain, France, Ireland, Italy Netherlands, Switzerland, South Africa, Slovenia.

device · product 2 of 2

Check=Flo Performer Introducer, 14.0Fr, Reference Part Number(RPN) REF RCFW-14.0-0-38-30-RB, Order Number (GPN) REF G08957,

Z-1787-2025

Recall number: Z-1787-2025
Initiated: April 17, 2025
Classification: Class II
Status: Ongoing
Recalling firm: Cook Incorporated
Quantity: 89 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Cook Medical identified that devices from the affected device lots may contain the incorrectly sized introducer sheath.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Cook Medical identified that devices from the affected device lots may contain the incorrectly sized introducer sheath.

Code information

UDI/DI 00827002089570, Lot Number 16376242

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Belgium, Germany, Spain, France, Ireland, Italy Netherlands, Switzerland, South Africa, Slovenia.