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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 71336

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

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Event summary

Timeline bucket
February 17, 2015
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

Velocity" Biopsy Valve, 25 units per box, Product Usage: The disposable Velocity biopsy valve is used to cover the opening of the biopsy inlet port of a flexible gastrointestinal endoscope. The Velocity biopsy valve provides access for endoscopic device passage and exchange, helps maintain insufflation, and minimizes leakage of biomaterial from the accessory port throughout the gastrointestinal endoscopic procedure. The Velocity biopsy valve provides a connection for irrigation through the Velocity irrigation pump.

Z-1943-2015
Recall number
Z-1943-2015
Initiated
February 17, 2015
Classification
Class II
Status
Terminated
Recalling firm
US Endoscopy Group Inc
Quantity
2,173 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The company has received reports of structural non conformance at the connection between the valve body and the irrigation tube, resulting in separation of the components during use.

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

The company has received reports of structural non conformance at the connection between the valve body and the irrigation tube, resulting in separation of the components during use.

Code information

M/N: 00711140; Lot #'s: 1401267, 1404503, 1408953, 1413362, 1417521, 1420739, 1422288, 1422747, 1424014, and 1500443.

Distribution pattern

Worldwide Distribution - US Nationwide in the states of: CA, CO, IA, MA, OH, TX & WV and the countries of: Brazil, Costa Rica, Croatia, Czech Republic, Egypt, France, Germany, India, Indonesia, Italy, Latvia, Lithuania, Philippines, Poland, Romania, Russian Federation, Slovenia & South Africa.