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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 63047

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
December 22, 2011
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
US Endoscopy Group Inc

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

1 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 1

Infinity¿ sampling device, Cytology Brush, United States Endoscopy Group, Inc., 5976 Heisley Road, Mentor, OH 44060 The Infinity sampling device is a disposable cytology brush used to retrieve cytological cell samples in the gastrointestinal tract.

Z-2396-2012
Recall number
Z-2396-2012
Initiated
December 22, 2011
Classification
Class II
Status
Terminated
Recalling firm
US Endoscopy Group Inc
Quantity
393 Devices

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
US Endoscopy received five complaints which noted difficulty in deploying the cytology brush through the catheter.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

US Endoscopy received five complaints which noted difficulty in deploying the cytology brush through the catheter.

Code information

Lot numbers 49680, 50793, 50794, 50795, 52577 & 53023.

Distribution pattern

Worldwide Distribution - USA including CA, FL, GA, IA, IL, MA, ME, MN, MO, NC, NH, OH, OK, PA, TN, TX, VA, WA & WV and the countries of Australia, Canada, Columbia, Finland, Germany, India, Israel, Italy, Netherlands, New Zealand & United Kingdom.