Olympus Corporation of the Americas recalls
145 recalls in our records from 2015 to 2026: 145 FDA medical devices.
Recalls with full detail pages
-
Olympus Corporation of the Americas medical device recall: Olympus High Flow Insufflation Unit. Model Number: UHI. Used for…
Issue with software algorithm which may lead to overpressure events.
-
Olympus Corporation of the Americas medical device recall: Brand Name: Single Use Ligating Device Product Name: Olympus…
Potential that the ligation loop was unable to release or detach as expected during use, causing the loop to become unintentionally fixed around patient anatomy.
-
Olympus Corporation of the Americas medical device recall: Bronchovideoscope Olympus Bf Type 1T150
Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and…
-
Olympus Corporation of the Americas medical device recall: ViziShot 2FLEX. Single Use Aspiration Needle. Model Number:…
Potential for undetected, deformed a-traumatic tips.
-
Olympus Corporation of the Americas medical device recall: Olympus Single Use Guide Sheath Kits with the following product…
Potential for the radiopaque tip of the guide sheath component to disassociate and fall off into the patient.
-
Olympus Corporation of the Americas medical device recall: Olympus MAJ-891 Forceps/Irrigation Plug
Potential for inadvertent retention of biomaterial when the reprocessing procedure is not performed as instructed, so as not completely removing and disassembling the…
Earlier and other recalls
These link to the official agency notice.
-
Olympus Corporation of the Americas medical device recall: Olympus M3 Gold Autoclavable Foroblique Telescope 30. Model Number:… Official notice ↗
There are identified discrepancies between the sterilization parameters listed in the Instructions for Use and the sterilization parameters listed in the Japanese…
-
Olympus Corporation of the Americas medical device recall: Olympus Tripp-Lite P580-025 25ft DisplayPort Cable Official notice ↗
While in the high-power operating mode, a video dropout/blackout may occur when using a particular accessory cable.
-
Olympus Corporation of the Americas medical device recall: Olympus EZDilate Endoscopic Balloon Dilator Wired-guided 11 Official notice ↗
Potential for the inflation chart label affixed to the shaft of the device to be incorrect and indicate a balloon diameter of 18, 19, or 20 mm,
-
Olympus Corporation of the Americas medical device recall: Olympus BiCOAG Hemostasis Probe 10Fr Coaxial Connector. Model/Catalog… Official notice ↗
Potential for detachment of ceramic tip due to manufacturing without the designated amount of adhesive.
-
Olympus Corporation of the Americas medical device recall: Powerseal 5 Mm Official notice ↗
Potential labeling deficiency in which an outer shelf box is incorrectly labeled as a 37-cm device.
-
Olympus Corporation of the Americas medical device recall: Olympus 4K UHD LCD Monitor. Model Number: OEV321UH. An electrically… Official notice ↗
Potential for the HDMI and DisplayPort (DP) connectors can become faulty resulting in image loss or image abnormalities.
-
Olympus Corporation of the Americas medical device recall: Olympus High Flow Insufflation Unit - UHI-4. Model Number: UHI-4 Official notice ↗
Potential for unexpected instances where the front panel display turns off unexpectedly, and air delivery (insufflation) ceases.
-
Olympus Corporation of the Americas medical device recall: Olympus Toomey Evacuator 30cc with Adaptor. Model Number: 188 Official notice ↗
Some sterilization parameters included in the IFU may not consistently render the devices adequately sterile and therefore should no longer be used to sterilize the…
-
Olympus Corporation of the Americas medical device recall: Olympus Single Use Distal Cover Official notice ↗
Olympus has developed and released newly designed version of the Distal Cover (MAJ-2315) to replace previous design of the Single Use Distal Covers.
-
Olympus Corporation of the Americas medical device recall: Olympus Thunderbeat II Shears w/Ultrasonic Mode Official notice ↗
Potential for detachment of a distal tip component of the device during use.
-
Olympus Corporation of the Americas medical device recall: OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog… Official notice ↗
Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.
-
Olympus Corporation of the Americas medical device recall: Brand Name: Olympus SOLTIVE Premium SuperPulsed Laser System Product… Official notice ↗
Following a complaint investigation, Olympus identified a potential defect in the 24V power supply module in some SOLTIVE laser units which may cause the system to…
-
Olympus Corporation of the Americas medical device recall: Brand Name: Olympus Everest Bipolar Cutting Forceps Official notice ↗
Olympus identified that the Cutting Forceps contain components for which the supplier did not adequately validate the welding process. Defective welds can result in the…
-
Olympus Corporation of the Americas medical device recall: Olympus Endoscope Suction Valve - MAJ-1443. Model Number: MAJ-1443 Official notice ↗
The MAJ-1443 and MAJ-1444 are no longer reprocessing compatible with the OER-Pro and OER-Elite automated endoscope reprocessors.
-
Olympus Corporation of the Americas medical device recall: Brand Name: Olympus ShockPulse-SE Lithotripsy System with Generator… Official notice ↗
Mis-wired component-the improperly wired component can result in additional noise on the power supply output. Noise on the ultrasonic input circuit is not consistent…
-
Olympus Corporation of the Americas medical device recall: Brand Name: ShockPulse-SE Lithotripsy System SPL-SR Product Name:… Official notice ↗
Ongoing investigations identified additional instances of the device Generator remaining in a blinking phase waiting to recognize the transducer. Damage to the…
-
Olympus Corporation of the Americas medical device recall: Olympus Single use Biopsy Valve. Model/Catalog Number: MAJ-210. 20… Official notice ↗
Potential for rubber fragment detachment during use.
-
Olympus Corporation of the Americas medical device recall: Olympus Cystoscope Outer Sheath Official notice ↗
Product being removed due to incompatibility when used in conjunction with a GreenLight Laser for BPH therapy which could damage the tip of the device.
-
Olympus Corporation of the Americas medical device recall: Olympus Resection Sheath. Model No. A22014A and A22014T. for… Official notice ↗
Complaints of the ceramic tip of the resection sheath breaking have been received.
-
Olympus Corporation of the Americas medical device recall: Olympus Thunderbeat 5 mm Official notice ↗
Firm is initiating a removal due to continued reports of adverse events.
-
Olympus Corporation of the Americas medical device recall: Brand Name: CleverCut Product Name: Single Use 3-Lumen Sphincterotome… Official notice ↗
Devices which did not undergo thermoforming could deform and lose performance.
-
Olympus Corporation of the Americas medical device recall: Brand Name: Single Use Electrosurgical Knife Product Name: Olympus… Official notice ↗
A deterioration of the cutting knife, including overheating and burning, can contribute to tip breakage during use.
-
Olympus Corporation of the Americas medical device recall: Brand Name: EVIS EXERA III Duodenovideoscope Product Name: Olympus… Official notice ↗
Continued reports of positive cultures and infections have identified updates to the reprocessing materials to minimize potential deviations in TJF duodenoscope…
-
Olympus Corporation of the Americas medical device recall: Brand Name: EZDilate Nephrostomy Balloon Catheter and Inflation… Official notice ↗
Device kits contained an incorrectly sized 4mm x 4cm urinary tract balloon catheter (BURS0404) instead of the correct 8mm x 15cm nephrostomy tract balloon catheter…
-
Olympus Corporation of the Americas medical device recall: Brand Name: Olympus Single Use Electrosurgical Snare SD-400 Product… Official notice ↗
Sterility compromised from small holes that may occur during packaging of the device pouches into the shelf carton and/or during transportation of the shelf carton.
-
Olympus Corporation of the Americas medical device recall: Brand Name: Lithotriptor Official notice ↗
The device may either fail to start up, or the transducer may start briefly and then stop, accompanied by an error light on the generator. In addition, the body of the…
-
Olympus Corporation of the Americas medical device recall: Electrosurgical Official notice ↗
Potential for the ESG-410 Electrosurgical Generator to display an error message: "E0662 System Error", followed by either automatic single reboots of the device, or…
-
Olympus Corporation of the Americas medical device recall: Blue Silicone Official notice ↗
Discrepancies between sterilization instructions in the Japanese language product package inserts and those published in the manufacturer product Instructions For Use…
-
Olympus Corporation of the Americas medical device recall: Brand Name: Powered Laser Surgical Instrument Product Name: SOLTIVE… Official notice ↗
Potential for thermal incident including an unexpected occurrence of smoke, sparks, burning, or unsteady flames during clinical use. The fracturing of the fiber is the…
-
Olympus Corporation of the Americas medical device recall: Olympus EVIS EXERA III Duodenovideoscope. Model Number: TJF-Q190V Official notice ↗
Recent post-market surveillance data suggests a possible association of higher microbial contamination levels from TJF duodenoscopes when manual cleaning was delayed…
-
Olympus Corporation of the Americas medical device recall: Brand Name: Powered Laser Surgical Instrument Product Name: SOLTIVE… Official notice ↗
Preset treatment parameters are not consistently being used in accordance with the IFU.
-
Olympus Corporation of the Americas medical device recall: Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand… Official notice ↗
The probe tips of the hand instruments are being damaged or breaking including pad damage and detachment.
-
Olympus Corporation of the Americas medical device recall: LithoCrushV Single Use Mechanical Lithotriptor V. Model Number:… Official notice ↗
Potential for distal tip tearing of the Mechanical Lithotriptor V.
-
Olympus Corporation of the Americas medical device recall: Duravent Silicone Ventilation Tube. Model Number: 240075 Official notice ↗
Potential that Duravent Silicone Ventilation Tubes may contain incorrect product, specifically, 1.32 mm Tiny T Tubes (model: 70240076) instead of the intended Duravent…
-
Olympus Corporation of the Americas medical device recall: EVIS EXERA III Gastrointestinal Videoscope GIF-1TH190. Model Number:… Official notice ↗
High-level disinfection ("HLD") with Acecide-C disinfectant in the Olympus OER-Pro Automated Endoscope Reprocessor ("AER") has been removed as a compatible reprocessing…
-
Olympus Corporation of the Americas medical device recall: Brand Name: EVIS EXERA III Gastrointestinal Videoscope GIF-1TH190… Official notice ↗
To better define the drying procedures described in the IFU to improve the instructions for easier understanding of each drying step after human errors and concerns were…
-
Olympus Corporation of the Americas medical device recall: Brand Name: Olympus Product Name: Cystoscope Outer Sheath… Official notice ↗
Olympus is removing the statement of compatibility with a GreenLight Laser for BPH therapy from the Instruction for Use (IFU) due to the potential for a damaged tip…
-
Olympus Corporation of the Americas medical device recall: Brand Name: UroPass Ureteral Access Sheaths Product Name: Ureteral… Official notice ↗
Exposure of the UroPass product to Ultraviolet ( UV ) Radiation can cause brittleness of the device dilator tip, which may lead to broken dilator tips in the package or…
-
Olympus Corporation of the Americas medical device recall: Olympus Electrosurgical Generator Official notice ↗
There was an increase in complaints indicating an occurrence of system error E1226 "Could not write to Audio Buffer" during procedures using the ESG-410 (SEP).
-
Olympus Corporation of the Americas medical device recall: Olympus Endoscopic Flushing Pump Official notice ↗
During product testing, Olympus identified an intermittent loss of function of the OFP-2 Flushing Pump caused by an internal component connection failure.
-
Olympus Corporation of the Americas medical device recall: Quest Spectrum 3 Fluorescent Imaging System Model/Catalog Number:… Official notice ↗
Does not meet the requirements for electromagnetic compatibility (EMC) of the standard IEC 60601-1-2. Electromagnetic interference occurring during a procedure may cause…
-
Olympus Corporation of the Americas medical device recall: Olympus Gastrointestinal Videoscope Official notice ↗
It was discovered during device performance testing that the CCD imaging sensors were programmed with the incorrect color correction data and therefore, specifications…
-
Olympus Corporation of the Americas medical device recall: EZDilate Wire Guided Balloon- Indicated for use in adult and… Official notice ↗
Mislabeled Glo Cath Label (attached to the device) states: 11 mm, 12 mm, 13 mm however the balloon is 8.5mm, 9.5mm and 10.5 mm and may result in prolonged surgery. All…
-
Olympus Corporation of the Americas medical device recall: Soltive Premium SuperPulsed Laser - Intended for incision Official notice ↗
The term Bladder Stone was incorrectly translated in both Spanish and Portuguese to Kidney Stone(Clculo renal) on the systems Graphical User Interface (GUI), a potential…
-
Olympus Corporation of the Americas medical device recall: EVIS EXERA III Video System Center Model Number CV-190. Intended to… Official notice ↗
Certain serial numbers of the CV-190 do not start up properly because parts that deviated from the specification were assembled into the power supply unit.
-
Olympus Corporation of the Americas medical device recall: Olympus Triangle Tip Electrosurgical Knives- to be used with Olympus… Official notice ↗
Due to increase in complaints for the KD-640L and KD-645L Triangle Tip Electrosurgical Knives breaking off during use -issuing reminder to users to utilize the…
-
Olympus Corporation of the Americas medical device recall: Soltive Premium SuperPulsed Laser System Official notice ↗
Difficulties in pairing the wireless footswitch with the Soltive Laser, potentially delaying the surgical procedure.
-
Olympus Corporation of the Americas medical device recall: The Everest Bipolar Cutting Forceps are intended to be passed through… Official notice ↗
Fractures and breakages in packaging trays and Tyvek covers, which may result in a sterility breach
-
Olympus Corporation of the Americas medical device recall: ESG-410 Electrosurgical Generator- In conjunction with… Official notice ↗
Electrosurgical Generators ESG-410 does not power on upon use, may result in delays in initiating treatment or prolonged surgery
-
Olympus Corporation of the Americas medical device recall: EasySuite 4K Integrated Operating Room System Model/Catalog Number:… Official notice ↗
A subset of the ES4K systems do not have complete records for earth leakage testing. The earth leakage test is a series of measurements intended to confirm that the…
-
Olympus Corporation of the Americas medical device recall: OES 4000 Hysteroscope Official notice ↗
The required leakage test was not performed following of a re-work for a non-conformity. This could potentially result in liquid ingress into the eyepiece and cause a…
-
Olympus Corporation of the Americas medical device recall: InstaClear Lens Sheath. The InstaClear lens cleaner system and… Official notice ↗
Potential for distal end of the sheath to break off during a procedure.
-
Olympus Corporation of the Americas medical device recall: POWERSEAL 5 mm Official notice ↗
Upon initial activation of the seal function, the POWERSEAL non-conformance results in an immediate Incomplete Seal Cycle tone with the accompanying message on the…
-
Olympus Corporation of the Americas medical device recall: Hemostasis Probe Official notice ↗
The BICOAG Hemostasis Probe with a coaxial plug was mispackaged into the package and labeled as a BICOAG Hemostasis Probe with a fixed pin connector.
-
Olympus Corporation of the Americas medical device recall: SOLTIVE Pro SuperPulsed Laser Official notice ↗
A non-compliant power cord may have been supplied in regions that do not utilize the Type B or Type E/F plug configurations.
-
Olympus Corporation of the Americas medical device recall: Insufflation unit Official notice ↗
Olympus has become aware of an increased trend of both repairs and customer complaints reporting "UHI-4 stopping air supply due to the front panel LED turning off".
-
Olympus Corporation of the Americas medical device recall: InstaClear Lens Cleaner-indicated for use during routine diagnostic… Official notice ↗
Japanese IFU version had slightly different language and illustrations from the English IFU, which could contribute to the tip and plate falling off. In order to…
-
Olympus Corporation of the Americas medical device recall: Colonoscope Official notice ↗
Specific repaired colonovideoscopes were assembled without an adhesive which protects them from certain physical conditions such as high levels of vibration, fluctuation…
-
Olympus Corporation of the Americas medical device recall: Esg Pk Cutting Forceps Official notice ↗
The jaw may fracture prior to the procedure during the inspection instructed per the IFU, or during the procedure.
-
Olympus Corporation of the Americas medical device recall: Single Use Distal Cover MAJ-2315 Used with: EVIS EXERA III… Official notice ↗
Single Use Distal Cover MAJ-2315 may unexpectedly detach from the duodenoscope during use result include the risk of mucosal injury, tissue damage, bleeding,…
-
Olympus Corporation of the Americas medical device recall: Water Filter MAJ-2318. This MAJ-2318 water filter has been designed… Official notice ↗
Water filter may have been assembled incorrectly, resulting in unfiltered tap water being used for reprocessing. This may expose a patient to a potentially contaminated…
-
Olympus Corporation of the Americas medical device recall: Olympus/Gyrus Paparrela-Type Vent Tube 1.02MM Official notice ↗
The expiration date is missing from the primary (inner) packaging. The secondary (outer) box label correctly states the expiration date of February 12, 2033, for this lot
-
Olympus Corporation of the Americas medical device recall: EZDilate Fixed Wire Balloon 6-7-8. Indicated for endoscopic dilation… Official notice ↗
Product balloon issues: inflating, deflating and/or retrieving the devices; reports of bursting and leaking and events involving foreign body in patient and prolonged…
-
Olympus Corporation of the Americas medical device recall: SOLTIVE SuperPulsed Laser Fibers Model Numbers TFL-FBX150S Official notice ↗
Olympus identified inconsistencies in the Instructions for Use regarding cleaning the fiber tip and fiber cleaving and stripping instructions. Following the current…
-
Olympus Corporation of the Americas medical device recall: SOLTIVE SuperPulsed Laser Fibers Official notice ↗
Affected products may potentially have a breached sterile pouch seal. A breached sterile pouch seal may lead to minor procedure delays (if noticed prior to use) or…
-
Olympus Corporation of the Americas medical device recall: Soltive SuperPulsed Laser System TFL Fiber Stripper Official notice ↗
The strippers and cleavers are provided non-sterile and labelled as reusable/autoclavable. Olympus does not have validated cleaning and sterilization instructions. Use…
-
Olympus Corporation of the Americas medical device recall: Olympus ENDOEYE HD II Rigid Videoscope Catalog Numbers: WA50040A Official notice ↗
Reports of a pink or green coloration of the image. If the issue is encountered during a procedure, device exchange could potentially result in prolonged surgery;…
-
Olympus Corporation of the Americas medical device recall: Olympus Endoeye Flex Deflectable Videoscope Official notice ↗
Instructions for Use-User Deviations related to the reprocessing of the videoscope detailed in the Reprocessing Manual Instructions. The steps are required for the…
-
Olympus Corporation of the Americas medical device recall: ACMI Roller Bar Electrodes bearing incorrect pouch label of ACMI USA… Official notice ↗
Incorrect pouch labels, the contents within the mislabeled pouch were Roller Bar electrodes.
-
Olympus Corporation of the Americas medical device recall: Tracheal Intubation Fiberscope Olympus Lf-Gp Official notice ↗
Fiberscopes do not have adequate data to support that the suction flow rate meets the device specification.
-
Olympus Corporation of the Americas medical device recall: EVIS EXERA III Gastrointestinal Videoscope Official notice ↗
Sterilization failures when devices are sterilized per the Reprocessing Manual due to lack of drying time for the endoscope channel.
-
Olympus Corporation of the Americas medical device recall: BRONCHOVIDEOSCOPE OLYMPUS BF TYPE Model Numbers BF-1T150 Official notice ↗
There is a risk of endobronchial combustion if high-frequency cauterization is performed while supplying oxygen [and/or] the electrode section of the electrosurgical…
-
Olympus Corporation of the Americas medical device recall: Olympus High-Flow Insufflation Unit Official notice ↗
There have been reports of patients suffering arrhythmias, reported as short cardiac arrests, during surgical procedures where UHI-4s were used. These events may have…
-
Olympus Corporation of the Americas medical device recall: Thunderbeat Official notice ↗
Thunderbeats blue seal button may remain in the engaged position after the button is released and not immediately return to a neutral position may result in prolonged…
-
Olympus Corporation of the Americas medical device recall: Veran:SPiN Thoracic Navigation System Models: SYS-4230 SPiN Thoracic… Official notice ↗
Non-conformances in Veran devices (ig4 Image Guided System, SPiN Thoracic Navigation System, SPiN Planning Laptop Workstation, and all associated navigation instruments)…
-
Olympus Corporation of the Americas medical device recall: Visera Hysterovideoscope Olympus HYF Type V Official notice ↗
IFU labeling is being updated to revise EtO gas mixture and elimination of reusable cleaning brushes.
-
Olympus Corporation of the Americas medical device recall: Olympus Bronchovideoscope Official notice ↗
Complaint of endoscope model becoming lodged in the endotracheal tube connector due to diameter being too large.
-
Olympus Corporation of the Americas medical device recall: Evis Exera Iii Duodenovideoscope Olympus Tjf-Q190V Official notice ↗
Recent reports of patient infection.
-
Olympus Corporation of the Americas medical device recall: The Air/Water Valve is provided/used with the following Endoscopes:… Official notice ↗
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 automated endoscope…
-
Olympus Corporation of the Americas medical device recall: HF Resection Electrodes - HF resection electrodes are part of a… Official notice ↗
Additional Caution statements in IFU: (1) Due to complaints where the loop wire at the distal end of the HF resection electrode broke after getting in contact with metal…
-
Olympus Corporation of the Americas medical device recall: UroPass Ureteral Access Sheaths Official notice ↗
Dilator tips may break in the package and in patients during surgical procedures.
-
Olympus Corporation of the Americas medical device recall: VISERA Tracheal Intubation Videoscope OLYMPUS LF Type V- For airway… Official notice ↗
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 OERs. The addendum…
-
Olympus Corporation of the Americas medical device recall: Always-On Tip Tracked Instruments Official notice ↗
Electromagnetic (EM) sensor tracking malfunction impacts the use of navigation functionality during endobronchial procedures and prompts the system to report a coil…
-
Olympus Corporation of the Americas medical device recall: Olympus OES BRONCHOFIBERSCOPE BF Type Official notice ↗
There have been complaints of endobronchial combustion during therapeutic laser procedures with the bronchoscope.
-
Olympus Corporation of the Americas medical device recall: Single Use Repositionable Clip QUICKCLIP PRO 165 CM 10/BX- Intended… Official notice ↗
Complaints on clip deployment occurring during clinical procedures, leading to hazardous situations where clips fail to achieve their expected function or deploy…
-
Olympus Corporation of the Americas medical device recall: ViziShot 2 Single Use Aspiration Needle Official notice ↗
Product non-conformance pertaining to the angle of the needle does not meet manufacturing specifications and remained unbent, resulting to slight resistance experienced…
-
Olympus Corporation of the Americas medical device recall: Olympus Single Use Distal Cover Model Number MAJ-2315 used with EVIS… Official notice ↗
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 could include the…
-
Olympus Corporation of the Americas medical device recall: Single Use Rotatable Clip Fixing Device Model HX 201LR 135 - Rotatable Official notice ↗
There have been complaints that the clip did not come out of the tube sheath during the procedure.
-
Olympus Corporation of the Americas medical device recall: EVIS EXERA III Colonovideoscope-For endoscopy and endoscopic surgery… Official notice ↗
A single CF-Q180AL colonovideoscope was utilized in a veterinary endoscopy procedure in advance of being assigned to a medical facility as a service loaner in error,…
-
Olympus Corporation of the Americas medical device recall: SPiN Thoracic Navigation System Model: SYS-4000 Official notice ↗
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 incorrect DVI cable…
-
Olympus Corporation of the Americas medical device recall: HF Resection Electrodes Official notice ↗
An incompatible HF cable may be packaged with the HF Resection Electrodes. This cable cannot be connected to the electrosurgical generator and may lead to delay or…
-
Olympus Corporation of the Americas medical device recall: Berkeley VC-10 Vacuum Curettage System Official notice ↗
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 been reported adverse…
-
Olympus Corporation of the Americas medical device recall: Olympus POWERSEAL 5MM Official notice ↗
An out of specification component preventing the blue retention ring from keeping the rotation knob in place. This may result in a loose rotation collar and retention…
-
Olympus Corporation of the Americas medical device recall: ShockPulse-SE Lithotripsy Generator Model/Serial: SPL-S Official notice ↗
Mis-wired component-the improperly wired component can result in additional noise on the power supply output. Noise on the ultrasonic input circuit is not consistent…
-
Olympus Corporation of the Americas medical device recall: SOLTIVE SuperPulsed Laser Fibers Official notice ↗
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.
-
Olympus Corporation of the Americas medical device recall: EVIS EXERA II Gastrointestinal Videoscope-indicated for use within… Official notice ↗
Part (A-rubber) intended for a different model of gastrointestinal videoscope may have been used when replacing part on GIF-HQ190 during the last repair at Olympus. An…
-
Olympus Corporation of the Americas medical device recall: Colonovideoscope Model CF-H180AL Official notice ↗
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 normal CF-H180AL and…
-
Olympus Corporation of the Americas medical device recall: Olympus CYSTONEPHROFIBERSCOPE Model: CYF-5 Official notice ↗
Incorrect adhesive used to secure the diopter ring and nameplate ring. Improperly connected diopter ring may result in the loss of adjustment function leading to a…
-
Olympus Corporation of the Americas medical device recall: Olympus DISPOSABLE GRASPING FORCEPS Official notice ↗
Forceps do not comply with Olympus standards for the amount of force required to open and close the forceps
-
Olympus Corporation of the Americas medical device recall: Olympus Uretero-reno videoscope Official notice ↗
The bending section of the URF-V2 may crack, resulting in an abnormal shape or abnormal angulation of the bending section.
Firm names are matched across agencies by name only. Different companies with similar names may be grouped together; check each official notice.