Recall archive
110 recalls · page 3 of 5
Reported Dec 20, 2023
TRACHEAL INTUBATION FIBERSCOPE OLYMPUS LF-GP, Model Number: LF-GP
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Olympus Corporation of the Americas
Matched: Brand · Product · Product details — Fiberscopes do not have adequate data to support that the suction flow rate meets the device specification.
FDA (openFDA device enforcement)
Reported Nov 15, 2023
BRONCHOVIDEOSCOPE OLYMPUS BF TYPE Model Numbers BF-1T150, BF-1T60, BF-P150 BF-P60 and EVIS EXERA BRONCHOVIDEOSCOPE…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Olympus Corporation of the Americas
Matched: Brand · Product · Product details — There is a risk of endobronchial combustion if high-frequency cauterization is performed while supplying oxygen [and/or] the electrode section of the…
6 more products in this recall
FDA (openFDA device enforcement)
Reported Oct 25, 2023
Olympus High-Flow Insufflation Unit, Model UHI-4. For laparoscopic surgery.
High riskUsing this product could cause serious injury, illness or death — stop using it now.Olympus Corporation of the Americas
Matched: Brand · Product · Product details — There have been reports of patients suffering arrhythmias, reported as short cardiac arrests, during surgical procedures where UHI-4s were used.…
FDA (openFDA device enforcement)
Reported Oct 18, 2023
THUNDERBEAT, 5MM, 35CM, Front-actuated Grip Type S. Model: TB-0535FCS Indicated for open, laparoscopic (including…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Olympus Corporation of the Americas
Matched: Brand — Thunderbeats blue seal button may remain in the engaged position after the button is released and not immediately return to a neutral position may…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Oct 11, 2023
Veran:SPiN Thoracic Navigation System Models: SYS-4230 SPiN Thoracic Navigation System - 230V 50Hz SYS-4000 SPiN…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Olympus Corporation of the Americas
Matched: Brand — Non-conformances in Veran devices (ig4 Image Guided System, SPiN Thoracic Navigation System, SPiN Planning Laptop Workstation, and all associated…
5 more products in this recall
FDA (openFDA device enforcement)
Reported Sep 6, 2023
EVIS EXERA III DUODENOVIDEOSCOPE OLYMPUS TJF-Q190V
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Olympus Corporation of the Americas
Matched: Brand · Product · Product details — Recent reports of patient infection.
16 more products in this recall
FDA (openFDA device enforcement)
Reported Aug 30, 2023
The Air/Water Valve is provided/used with the following Endoscopes: ULTRASONIC GASTROFIBERSCOPE, ULTRASONIC…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Olympus Corporation of the Americas
Matched: Brand · Reason for recall — The air/water valve MAJ-1444 used with OER-Pro and OER-Elite may become damaged and result in loss of the one-way valve functionality by repeated…
FDA (openFDA device enforcement)
Reported Aug 23, 2023
UroPass Ureteral Access Sheaths, 5 pieces/box
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Olympus Corporation of the Americas
Matched: Brand — Dilator tips may break in the package and in patients during surgical procedures.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Aug 16, 2023
VISERA Tracheal Intubation Videoscope OLYMPUS LF Type V- For airway management which includes endoscopic observation to…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Olympus Corporation of the Americas
Matched: Brand · Product · Product details — Revised OER-Pro, OER-Elite, OER-Mini endoscope reprocessor labeling- the LF-V and LF-P are no longer compatible endoscopes for reprocessing in the…
4 more products in this recall
FDA (openFDA device enforcement)
Reported Aug 9, 2023
Always-On Tip Tracked Instruments (SPiN Drive¿ instruments) Brush, 15mm L, 1.8mm OD Intended for use in clinical…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Olympus Corporation of the Americas
Matched: Brand — Electromagnetic (EM) sensor tracking malfunction impacts the use of navigation functionality during endobronchial procedures and prompts the system…
7 more products in this recall
FDA (openFDA device enforcement)
Reported Jul 26, 2023
Olympus OES BRONCHOFIBERSCOPE BF Type, Model Numbers BF-XT40, BF-P60, BF-MP60, BF-1T60
High riskUsing this product could cause serious injury, illness or death — stop using it now.Olympus Corporation of the Americas
Matched: Brand · Product · Product details — There have been complaints of endobronchial combustion during therapeutic laser procedures with the bronchoscope.
6 more products in this recall
FDA (openFDA device enforcement)
Reported Jun 28, 2023
Single Use Repositionable Clip QUICKCLIP PRO 165 CM 10/BX- Intended for hemostatic metal clip for the GI Tract Catalog…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Olympus Corporation of the Americas
Matched: Brand — Complaints on clip deployment occurring during clinical procedures, leading to hazardous situations where clips fail to achieve their expected…
3 more products in this recall
FDA (openFDA device enforcement)
Reported May 31, 2023
Olympus Single Use Distal Cover Model Number MAJ-2315 used with EVIS EXERA III Duodenovideoscope TJF-Q190V; Item code:…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Olympus Corporation of the Americas
Matched: Brand · Product · Product details — The Single Use Distal Cover MAJ-2315 may cause mucosal injury and/or become detached from the endoscope during use. Consequences of a detached cover…
2 more products in this recall
FDA (openFDA device enforcement)
Reported Apr 26, 2023
Single Use Rotatable Clip Fixing Device Model HX 201LR 135 - Rotatable, 165cm long, 2.8 scope channel, standard clip…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Olympus Corporation of the Americas
Matched: Brand — There have been complaints that the clip did not come out of the tube sheath during the procedure.
FDA (openFDA device enforcement)
Reported Feb 22, 2023
EVIS EXERA III Colonovideoscope-For endoscopy and endoscopic surgery within the lower digestive tract (including the…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Olympus Corporation of the Americas
Matched: Brand — A single CF-Q180AL colonovideoscope was utilized in a veterinary endoscopy procedure in advance of being assigned to a medical facility as a service…
FDA (openFDA device enforcement)
Reported Feb 15, 2023
SPiN Thoracic Navigation System Model: SYS-4000 (SYS-4000D)
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Olympus Corporation of the Americas
Matched: Brand — A grainy image is observed when using a SPiN Vision Single-Use Flexible Bronchoscope (models INS-7100 or INS-7130) with the SYS-4000 system due to an…
FDA (openFDA device enforcement)
Reported Dec 14, 2022
HF Resection Electrodes, Model Numbers WA22602S, WA22603S, WA22621S and WA22657S
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Olympus Corporation of the Americas
Matched: Brand — An incompatible HF cable may be packaged with the HF Resection Electrodes. This cable cannot be connected to the electrosurgical generator and may…
FDA (openFDA device enforcement)
Reported Oct 19, 2022
Berkeley VC-10 Vacuum Curettage System, Model No. VC-10. For transcervical aspiration of the uterine cavity.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Olympus Corporation of the Americas
Matched: Brand · Reason for recall — Update to the Instruction for Use (IFU): Olympus is adding a new warning against the use of accessories which are not listed in the IFU. There have…
FDA (openFDA device enforcement)
Reported Oct 5, 2022
Olympus POWERSEAL 5MM, 23CM, CURVED JAW SEALER & DIVIDER, DOUBLE-ACTION Model Number: PS-0523CJDA. An electrosurgical…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Olympus Corporation of the Americas
Matched: Brand · Product · Product details — An out of specification component preventing the blue retention ring from keeping the rotation knob in place. This may result in a loose rotation…
2 more products in this recall
FDA (openFDA device enforcement)
Reported Aug 17, 2022
ShockPulse-SE Lithotripsy Generator Model/Serial: SPL-S
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Olympus Corporation of the Americas
Matched: Brand — Mis-wired component-the improperly wired component can result in additional noise on the power supply output. Noise on the ultrasonic input circuit…
FDA (openFDA device enforcement)
Reported Jul 6, 2022
SOLTIVE SuperPulsed Laser Fibers, Model# Labeled TFL-FBX150BS (Carton) - 150 Micron Ball Tip Single Use Fiber Model #…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Olympus Corporation of the Americas
Matched: Brand — Device model and size for affected lots of Laser Fibers may be mismatched between the product's carton, immediate pouch packaging, and/or the device.
FDA (openFDA device enforcement)
Reported Jun 29, 2022
Colonovideoscope Model CF-H180AL
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Olympus Corporation of the Americas
Matched: Brand — A (Camera unit) CCD intended for a different model of colonoscope may have been installed in the CF-H180AL, viewing angle would be narrower than a…
1 more product in this recall
FDA (openFDA device enforcement)
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)
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