Manufacturer
423 recalls in our database name Olympus Corporation of the Americas as the manufacturing or recalling firm.
Of the 423 recalls from Olympus Corporation of the Americas we have scored against our rubric, 27 (6%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 41 (10%) are Severe.
The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.
Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.
Olympus BRONCHOVIDEOSCOPE Model BF-Q170 is recalled nationally due to complaints of endobronchial combustion during therapeutic laser procedures, classified as FDA Class I.
Olympus is recalling OES Bronchofiberscope models due to reports of combustion during laser procedures. This poses a serious burn injury risk to patients.
The FDA recalls 284 Olympus EVIS EXERA bronchoscopes due to complaints of combustion during therapeutic laser procedures. Users should stop using affected models immediately.
Olympus Corporation recalls QuickClip Pro hemostatic clips (13,707 units) nationwide due to device deployment failures. Complaints include clip arms failing to open or close and premature tissue detachment during clinical procedures.
Olympus is recalling QUICKCLIP PRO hemostatic clips due to deployment failures that could prevent proper function during GI procedures. Clip arms may fail to operate or clips may detach prematurely from tissue.
Olympus recalls QUICKCLIP PRO hemostatic clips nationwide due to reported malfunction during clinical procedures, where clips fail to open, close, or detach from tissue as intended.
Olympus is recalling 340 QUICKCLIP PRO hemostatic clips used in gastrointestinal endoscopy due to reports of deployment failures during procedures, including clips that fail to open, close, or detach properly.
Olympus is recalling about 309,278 single-use endoscope covers that may detach during use, risking aspiration, inhalation, obstruction, or burns.
ViziShot 2 Aspiration Needles are being recalled because the needle angle does not meet specifications and remains unbent, causing resistance during use. No illnesses or injuries have been reported.
Olympus is recalling 1,297 boxes of fine needle aspiration needles due to a manufacturing defect where the needle angle does not meet specifications, resulting in slight resistance during needle advancement and retraction.
Olympus is recalling single-use rotatable clip fixing devices used in endoscopy procedures. The clips may fail to deploy from the tube sheath during use.
An Olympus EVIS EXERA III colonovideoscope was used in veterinary endoscopy before being designated as a medical facility loaner, creating potential for microbial contamination.
Olympus is recalling the SPiN Thoracic Navigation System (model SYS-4000) due to an incorrect DVI cable that produces grainy images during bronchoscopy procedures, requiring extended troubleshooting time.
Olympus Corporation is recalling HF Resection Electrodes because an incompatible cable may be included in packaging. The cable cannot connect to the electrosurgical generator, potentially delaying or canceling surgery.
Olympus recalls the VC-10 Vacuum Curettage System due to serious injury risk from incompatible collection canisters. The FDA warns users against using accessories not listed in the device's instructions.
Olympus Corporation is recalling certain POWERSEAL electrosurgical sealers due to an out-of-specification component that may allow the retention ring to loosen, potentially delaying surgical treatment.
Olympus POWERSEAL electrosurgical devices are recalled for a component defect that may prevent the retention ring from securing the rotation knob, potentially delaying treatment.
Olympus is recalling POWERSEAL 5MM electrosurgical sealers due to a component defect that may cause the rotation knob to loosen and delay surgical treatment.
Olympus Corporation recalls 2 units of the ShockPulse-SE Lithotripsy Generator due to a mis-wired component that causes improper power supply noise and EMC non-compliance, potentially affecting device reliability and treatment delivery.
Olympus is recalling certain SOLTIVE SuperPulsed Laser Fibers because device model and size may be mismatched between packaging and the actual device. This could result in the wrong laser fiber being used in medical procedures.
Olympus Corporation recalls a single colonovideoscope model CF-H180AL because an incorrect camera unit was installed, causing narrower viewing angle and potential device protrusion that could injure tissue. No injuries have been reported.
Olympus is recalling 8 EVIS EXERA II gastrointestinal videoscopes (Model GIF-HQ190) because an incorrect rubber component may have been installed during repair. The incorrect part does not meet the device's design specifications.
Olympus URETERO-RENO FIBERSCOPE Model URF-P6R recalled due to incorrect adhesive securing the diopter ring, which may cause loss of focus and in rare cases urinary tract perforation.
Olympus endoscopes with defective diopter ring adhesive may cause vision loss and, in rare cases, urinary tract perforation.
The Olympus URETERO-RENO FIBERSCOPE Model URF-P6 is recalled for incorrect adhesive securing the diopter ring. The defect may cause loss of adjustment function, blurred vision, and in rare cases, urinary tract perforation.