Recall archive
110 recalls · page 5 of 5
Reported Oct 10, 2018
Bronchovideoscope BF-160
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Olympus Corporation of the Americas
Matched: Brand · Reason for recall — The attachment of non-Olympus accessories to the bronchoscope s instrument channel port may have resulted in more applied force than expected and…
29 more products in this recall
FDA (openFDA device enforcement)
Reported Aug 1, 2018
Uretero-reno videoscope URF-V2 Uretero-reno videoscope URF-V2R
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Olympus Corporation of the Americas
Matched: Brand — Potential breakage of the endoscope s insertion tube bending section during surgical procedures
2 more products in this recall
FDA (openFDA device enforcement)
Reported Jun 27, 2018
Olympus JF-140F duodenoscopes (Model NumberJF-140F)
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Olympus Corporation of the Americas
Matched: Brand · Product · Product details — Issuance of validated, new reprocessing procedures. This corrective action is being undertaken as a result of ongoing manufacturer and FDA activities…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Mar 7, 2018
A20975A "Working insert, with ramp, one way" (Lots 13ZW to 172W; A20976A "Bridge, one way" (Lots 146W to 172W) and…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Olympus Corporation of the Americas
Matched: Brand · Reason for recall — Olympus has received complaints about fragments of adhesive which detached from inside the working channel of the referenced products. Cracking,…
FDA (openFDA device enforcement)
Reported Jul 5, 2017
High Frequency Resection Electrodes, endoscope, ac-powered and accessories The electrodes are used for endoscopic…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Olympus Corporation of the Americas
Matched: Brand — Loop wires breaking at the distal end of the Monopolar HF Resection Electrodes.
FDA (openFDA device enforcement)
Reported May 10, 2017
Olympus ENDOEYE HD II Video Telescopes Models: WA50040A Endoeye HD II, 10 mm, 0 deg., autoclavable; WA50042A Endoeye HD…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Olympus Corporation of the Americas
Matched: Brand · Product · Product details — A damaged temperature sensor at the endoscope's tip can cause the endoscope's distal end to become abnormally hot.
FDA (openFDA device enforcement)
Reported Mar 8, 2017
URF-P6 Uretero-reno fiberscope and URF-P6R Uretero-reno fiberscope
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Olympus Corporation of the Americas
Matched: Brand · Reason for recall — Olympus is recalling the URF-P6/P6R endoscopes due to a similar device (URF-V2/V2R endoscopes) but not identical, where adverse event complaints…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Dec 21, 2016
HF Cable WA00014A, Endoscopic electrosurgical unit and accessories
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Olympus Corporation of the Americas
Matched: Brand — Software malfunction that results in incorrect generation or display of error codes.
FDA (openFDA device enforcement)
Reported Oct 26, 2016
OER-Pro Endoscope Reprocessor, Endoscope washer/disinfector
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Olympus Corporation of the Americas
Matched: Brand — New warning requiring Users to conduct duodenoscope precleaning and manual cleaning even when using an Automated Endoscope Reprocessor (AER) that has…
FDA (openFDA device enforcement)
Reported Jun 8, 2016
EVIS EXERA Duodenovideoscope Olympus TJF Type 160F/VF used with an Olympus video system center, light source,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Olympus Corporation of the Americas
Matched: Brand · Product · Product details · Reason for recall — New reprocessing instructions for the Olympus TJF-160/VF duodenoscopes, consisting of revised manual cleaning and high level disinfection procedures…
FDA (openFDA device enforcement)
Reported Feb 10, 2016
Olympus TJF-Q180V flexible gastrointestinal Duodenoscope Product Usage: This instrument has been designed to be used…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Olympus Corporation of the Americas
Matched: Brand · Product · Product details · Reason for recall — Olympus America Inc is conducting a voluntary removal/corrective action of all TJF-Q180V duodenoscopes in order to replace the forceps elevator…
FDA (openFDA device enforcement)
Reported Dec 16, 2015
Olympus ENDOEYE HD II Video Telescopes. Models WA50040A ENDOEYE HD II, 10 mm, 0 degree, WA50042A ENDOEYE HD II 10 mm,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Olympus Corporation of the Americas
Matched: Brand · Product · Product details — A damaged temperature sensor at the ENDOEYE tip caused the distal end to become abnormally hot. Excessive heating of the ENDOEYE distal end could…
FDA (openFDA device enforcement)
Reported Oct 14, 2015
MAJ-1606 Instrument Channel Adaptor; a single use adapter which enables a connection between the endoscope's instrument…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Olympus Corporation of the Americas
Matched: Brand · Reason for recall — small puncture marks in a sterile package for an accessory to an Olympus device
FDA (openFDA device enforcement)
Reported Oct 7, 2015
EVIS EXERA II Gastrovideoscope OLYMPUS GF type UCT180; designed for endoscopic real-time ultrasound imaging, ultrasound…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Olympus Corporation of the Americas
Matched: Brand · Product · Product details — Insufficient information for specific cleaning accessories used for the cleaning and reprocessing of the GF-UCT180 ultrasound endoscope
FDA (openFDA device enforcement)
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