Olympus Corporation of the Americas recalled 7,803 HX-400U-30 single‑use ligating devices distributed nationwide in the United States. The ligation loop may fail to release or detach. Hospitals and clinics should stop using the device immediately and follow the recall instructions from Olympus or their healthcare providers.
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.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Olympus Corporation of the Americas or your healthcare provider for instructions. Notification method: Letter
Get instant alerts for Health & Personal Care recalls
Be the first to know. Free instant alerts to your inbox.
The HX-400U-30 is a single-use endoscopic ligating device that delivers a nylon loop snare during certain procedures. It is used in conjunction with an Olympus endoscope.
If the ligation loop cannot release or detach, it may stay fixed around patient tissue or anatomy, potentially causing constriction or injury during a procedure.
This recall is not described as part of a broader industry pattern.
Hospitals may need to pause procedures involving HX-400U-30 until replacement devices or guidance are issued. The recall affects 7,803 units distributed nationwide.
Recall letters, FDA recall page, and Olympus official notices
Replacement or remediation timelines typically 4-8 weeks depending on recall logistics
Keep recall letters, correspondences, receipts, photos of devices and packaging, and notes of any clinical decisions related to the recall
Model/Catalog Number: HX-400U-30 UDI: 04953170368615 All Lots which have not expired Quantity: 7803 units Distribution: US-wide distribution Sold at: Unknown When sold: Unknown Price: Unknown
No injuries or incidents have been reported.
Not sure what to do next? Our guide walks you through the process step by step.
Read: What to Do When You Find a Recalled ProductGet instant alerts for recalls that affect you. Free forever.
Olympus recalled 32 SOLTIVE Pro SuperPulsed Laser System units distributed worldwide after a defect in the 24V power supply may render the device inoperable. The defect can cause smoke or a burning smell, but the issue is contained within the laser console enclosure and self-extinguishing. Stop using the device and follow the manufacturer’s recall instructions.
Medline Industries, LP recalled 14,379 Olympus biopsy valve kits sold nationwide to hospitals and clinics. Olympus biopsy valves in the kits may detach rubber fragments from the valve slit. Hospitals and clinics should stop using the devices immediately and follow the recall instructions.
Medline Industries, LP recalled 14,379 Airway Exam Kits containing Olympus biopsy valves nationwide. The recall cites rubber fragments detaching from the slit of single-use biopsy valves. Potential harm includes a foreign body in the patient’s tracheobronchial tree, inflammatory response, hypoxia, and longer procedures. Providers and patients should stop using the kit and follow recall directions.
Olympus biopsy valves in Medline Industries, LP thoracic robotic biopsy valve kits are recalled nationwide. The recall covers 14,379 kits distributed across 13 states. Rubber fragments may detach from single-use biopsy valves, creating a risk of a foreign body in the patient’s tracheobronchial tree and possible inflammation or hypoxia. Healthcare providers and patients should stop using the device
Olympus Corporation of the Americas recalls 95,882 boxes of MAJ-210 single-use biopsy valves distributed nationwide to hospitals and clinics in the United States after reports of rubber fragments detaching during use. The defect can release fragments into the endoscope channel or patient. Healthcare facilities should stop using the device immediately and follow recall instructions.
Olympus Corp. of the Americas recalls 55 ShockPulse-SE Lithotripsy System units distributed internationally. Mis-wired component may create noise on the power supply and ultrasonic circuit. Hospitals and providers should stop using the device immediately and follow recall instructions. Notify Olympus or your healthcare provider for guidance.
Olympus Corporation of the Americas recalls 602 ShockPulse-SE Lithotripsy System reusable probes worldwide to hospitals. The recall cites a blinking generator that may fail to recognize the transducer and damage the transducer plug or generator receptacle. Hospitals and patients should stop using SPL-SR probes immediately and follow manufacturer recall instructions.
Olympus recalls 3,046 BF-P190 bronchovideoscopes sold nationwide in the US and 2,414 overseas. The recall centers on updated IFU guidance to clarify safe use with laser, argon plasma coagulation, and high-frequency therapy equipment. Clinicians and facilities should stop using the device immediately and follow Olympus recall instructions.