Recall archive
6 recalls · page 1 of 1
Reported Aug 3, 2016
Colonoscope Product Usage: Intended to provide optical visualization of and therapeutic access to the Lower…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Pentax Medical Company
Matched: Brand · Reason for recall — Pentax Medical Video Processor EPK-i5010 has been shipped with a reusable Pentax Medical water bottle assembly (OS-H4) which has not been cleared for…
5 more products in this recall
FDA (openFDA device enforcement)
Reported Jul 6, 2016
Bronchoscope Intended to provide optical visualization of and therapeutic access to the Airway and Bronchial Tree. This…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Pentax Medical Company
Matched: Brand · Reason for recall — Pentax has become aware that operational/cleaning accessories and therapeutic devices (e.g., clips, stents, balloons, etc.) can become lodged in an…
15 more products in this recall
FDA (openFDA device enforcement)
Reported Jun 8, 2016
Video Duodenoscope
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Pentax Medical Company
Matched: Brand · Reason for recall — Pentax Medical learned of reports of carbapenem-resistant Enterobacteriaceae (CRE) infection at a medical facility.
FDA (openFDA device enforcement)
Reported Aug 27, 2014
PENTAX Upper/Lower G.I. Endoscope OF-B130 and OF-B194 Gas/Water Feeding Valve
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Pentax Medical Company
Matched: Brand · Product · Product details · Reason for recall — The Instructions for Use for the Pentax OF-B130 and OF-B194 Gas/Water Valve IFU if not followed carefully may cause a potential risk to health.
FDA (openFDA device enforcement)
Reported Jul 30, 2014
EG-3630U Ultrasound Video Gastroscope EG-3830UT Ultrasound Video Gastroscope EG-3870UTK Ultrasound Video Gastroscope…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Pentax Medical Company
Matched: Brand — Aspiration needles used in combination with Ultrasound Gastroscopes can derail from the accessory elevator at the distal end of the endoscope. This…
FDA (openFDA device enforcement)
Reported Nov 6, 2013
PENTAX Endoscopic Accessories. OF-B194. Made in Japan. PENTAX Upper/Lower G.I. Endoscopes are provided with Air/Water…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Pentax Medical Company
Matched: Brand · Product · Product details · Reason for recall — PENTAX Medical has become aware of a product issue associated with the OF-B194 Gas/Water Feeding Valve. A manufacturing defect may cause improper…
FDA (openFDA device enforcement)
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