Recall archive
112 recalls · page 4 of 5
Reported Jun 22, 2022
Olympus CYSTONEPHROFIBERSCOPE Model: CYF-5
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Olympus Corporation of the Americas
Matched: Brand · Product · Product details — Incorrect adhesive used to secure the diopter ring and nameplate ring. Improperly connected diopter ring may result in the loss of adjustment…
2 more products in this recall
FDA (openFDA device enforcement)
Reported Jun 1, 2022
Olympus DISPOSABLE GRASPING FORCEPS, FG-51D
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 — Forceps do not comply with Olympus standards for the amount of force required to open and close the forceps
FDA (openFDA device enforcement)
Reported May 25, 2022
Olympus Uretero-reno videoscope, Model No. URF-V2
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Olympus Corporation of the Americas
Matched: Brand · Product · Product details — The bending section of the URF-V2 may crack, resulting in an abnormal shape or abnormal angulation of the bending section.
FDA (openFDA device enforcement)
Reported May 18, 2022
BF-MP60: OES Bronchofiberscope
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Olympus Corporation of the Americas
Matched: Brand — Bronchofiberscope Updated instructions on the use of certain chemicals to be used for reprocessing, conditions for ETO gas sterilization, rinsing…
3 more products in this recall
FDA (openFDA device enforcement)
Reported May 11, 2022
Ultrasonic Gastrovideoscope, GF-UC140P-AL5. Intended for endoscopic real-time ultrasound imaging.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Olympus Corporation of the Americas
Matched: Brand — GF-UC140P-AL5 is no longer a compatible endoscope for reprocessing in the OER-Pro and presents an infection control risk to patients
FDA (openFDA device enforcement)
Reported Feb 23, 2022
OER-Elite Endoscope Reprocessor-for use in cleaning and high-level disinfection of heat sensitive Olympus flexible…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Olympus Corporation of the Americas
Matched: Brand · Product · Product details — The detergent and alcohol tank tubing may have been incorrectly assembled in the OER-Elite. If the tubing is incorrectly assembled, alcohol will be…
FDA (openFDA device enforcement)
Reported Feb 9, 2022
Spiration Valve System (SVS) Valve in Cartridge -A one-way endobronchial valves indicated for adult patients with…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Olympus Corporation of the Americas
Matched: Brand — Mislabeled Patient Charge Label indicating model number SVS-V7-00 (7mm) instead of SVS-V9-00 (9mm)
FDA (openFDA device enforcement)
Reported Dec 22, 2021
EVIS EXERA II DUODENOVIDEOSCOPE OLYMPUS TJF-Q180V Model Number: TJF-Q180V
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Olympus Corporation of the Americas
Matched: Brand · Product · Product details — Use of a TJF-Q180V with adhesive deterioration or other damages may pose a risk of endoscope contamination due to ineffective reprocessing or fluid…
FDA (openFDA device enforcement)
Reported Nov 3, 2021
ASC PneumoLiner device, Part No. WA90500US (US market only) The Pneumoliner device is intended for use as a multiple…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Olympus Corporation of the Americas
Matched: Brand — Due to manufacturing error, the Pneumoliner Bag Distal Tab that exits the Introducer shaft is in the wrong orientation. This results in the user…
FDA (openFDA device enforcement)
Reported Oct 6, 2021
BF-N20 OES Bronchofiberscope, Model No. BF-N20
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Olympus Corporation of the Americas
Matched: Brand — The firm is issuing validated, new reprocessing instructions according to the FDA 2015 guidance, "Reprocessing Medical Devices in Health Care…
9 more products in this recall
FDA (openFDA device enforcement)
Reported Sep 29, 2021
EVIS EXERA BF-XT160 Bronchofibervideoscope, Model No. BF-XT160
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Olympus Corporation of the Americas
Matched: Brand — A gluing step was not performed during the manufacturing of the affected device's insertion tube. There is a potential for the insertion tube to…
FDA (openFDA device enforcement)
Reported Sep 15, 2021
Arc Endocuff Vision as follows: ARV110 ENDOCUFF-V M BLUE PK8, Part Number: E0420501; ARV120 ENDOCUFF-V L GREEN PK8,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Olympus Corporation of the Americas
Matched: Brand — Packaging seal defect may allow a breach of the package sterile barrier and result in patient infection.
FDA (openFDA device enforcement)
Reported Sep 8, 2021
Gyrus Acmi PKS Omni 5mm/33cm-intended for the electrosurgical coagulation, mechanical grasping, and dissection of…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Olympus Corporation of the Americas
Matched: Brand — Expired adhesive used as an electrical insulation barrier and as a secondary retention bond failed and could result in foreign body / biologic…
FDA (openFDA device enforcement)
Reported Aug 25, 2021
Soltive Premium Super Pulsed Laser System (TFL-PLS) & Pro Super Pulsed Laser System (TFL-SLS). Intended for incision,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Olympus Corporation of the Americas
Matched: Brand — Thermal injury following dusting and fragmenting treatment of ureteral stones when user exceeded the 20W standard presets
FDA (openFDA device enforcement)
Reported Mar 31, 2021
Duodenoscope and accessories, flexible/rigid - Product Usage: 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 — Olympus Medical Systems Corporation (OMSC) has received complaints of mucosal injury associated with the forceps elevator region of the TJF-Q190V…
FDA (openFDA device enforcement)
Reported Dec 9, 2020
Olympus Ultrasound Endoscope, Model number: GF-UCT140P-AL5 - Product Usage: used with other supporting equipment for…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Olympus Corporation of the Americas
Matched: Brand · Product · Product details — A new inspection step was added to the cleaning and disinfection section of the Instructions For Use (IFU) for this device in order to reduce the…
9 more products in this recall
FDA (openFDA device enforcement)
Reported Oct 28, 2020
Olympus CHF-CB30S Choledoscope Intended Use: The device was designed to be used with an Olympus TV camera system, light…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Olympus Corporation of the Americas
Matched: Brand · Product · Product details — The CHF-CB30S Device did not have a 510(k) clearance. Additionally, the device has been associated with breakage of the insertion section and…
FDA (openFDA device enforcement)
Reported Oct 7, 2020
Olympus Medical Systems Corporation (OMSC) Evis Exera II Bronchovideoscope Olympus BF Type Q180 (BF-Q180) All serial…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Olympus Corporation of the Americas
Matched: Brand · Product · Product details — The BF-Q180 bronchoscope is being recalled because it does not have a 510(k) clearance, and the device is associated with a higher rate of patient…
FDA (openFDA device enforcement)
Reported Aug 26, 2020
Smart Stapes Protheses Piston 0.4mm X 5.25 mm- Partial Ossicular Replacement Catalog Number: 70142168
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Olympus Corporation of the Americas
Matched: Brand — Mislabeled outer carton: packaged with the outer carton label stating the contents were the 70143662 Smart Piston but the inside package contents was…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jun 17, 2020
ENF-GP2 Rhino-Laryngo Fiberscope - Product Usage: is indicated for use within the nasal and nasopharyngeal lumen.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Olympus Corporation of the Americas
Matched: Brand — Products repaired with the incorrect service manual may be missing an O ring and are subject to rework with the corrected service manual.
FDA (openFDA device enforcement)
Reported Jun 10, 2020
OLYMPUS ShockPulse-SE Lithotripsy System, Model SPL-T Transducer
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 — A component of the Olympus ShockPulse Transducer was manufactured with non-conforming material that could allow water ingress during autoclaving…
FDA (openFDA device enforcement)
Reported Apr 29, 2020
Olympus Pleuravideoscope, Model LTF-160
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Olympus Corporation of the Americas
Matched: Brand · Product · Product details — There was no data to validate that the identified endo-therapy devices were compatible with certain pleuravideoscope models. Updated Operations…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Oct 23, 2019
Berkeley Disposa-Filter used with Berkeley VC-10 Vacuum Curettage System - Product Usage: designed for rapid…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Olympus Corporation of the Americas
Matched: Brand — Berkeley Disposa-Filter may possess an insufficient ultrasonic weld defect which joins the two-halves of the filter cartridge, thus the housing could…
FDA (openFDA device enforcement)
Reported Aug 14, 2019
Olympus MAJ-209 Single Use Suction Valves, Model Number MAJ-209 Product Usage: This product has been designed to be…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Olympus Corporation of the Americas
Matched: Brand · Product · Product details — There is a potential for the single use suction valve to come apart and/or remain stuck inside the endoscope.
FDA (openFDA device enforcement)
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