Olympus Recalls

11 recalls found for Olympus. Check if any of your products are affected.

Health & Personal Care
HIGH
FDA DEVICE

Olympus SOLTIVE Pro Laser System Recall 2026 — 32 Units Worldwide

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.

Olympus
Following a
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Health & Personal Care
HIGH
FDA DEVICE

Medline Airway Exam Kit Recalled for 14,379 Units Over Olympus Valve Detachment (2026)

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.

Medline Industries, LP
Kits contain
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Health & Personal Care
HIGH
FDA DEVICE

Olympus Biopsy Valves in Medline Thoracic Robotic Kits Recalled for Rubber Fragments (14,379 Kits,

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
Kits contain
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Health & Personal Care
HIGH
FDA DEVICE

Olympus MAJ-210 Single-Use Biopsy Valve Recalled for 95,882 Boxes Nationwide (2026)

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
Potential for
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Health & Personal Care
HIGH
FDA DEVICE

Olympus ShockPulse-SE Lithotripsy System Recall Expands to 55 Units in 5 Countries (2026)

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
Mis-wired component-the
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Health & Personal Care
HIGH
FDA DEVICE

Olympus ShockPulse-SE Lithotripsy System Recalled for 602 Reusable Probes (2025)

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
Ongoing investigations
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Health & Personal Care
HIGH
FDA DEVICE

Olympus HX-400U-30 Recall: 7,803 Endoscopic Ligation Devices Recalled in 2025

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.

Olympus
Potential that
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Health & Personal Care
HIGH
FDA DEVICE

Olympus BF-P190 Bronchoscope Recall Updated for 2025 IFU Guidance

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.

Olympus
Additional IFU
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Health & Personal Care
HIGH
FDA DEVICE

Olympus EVIS EXERA II BF-1T180 Bronchovideoscope Recall for IFU Update — 5,247 Units (2025)

Olympus Corporation of the Americas recalled 1,473 US units and 3,774 non-US units of the EVIS EXERA II bronchovideoscope BF-1T180. The recall concerns updated instructions for safe use with laser, argon plasma coagulation, and high-frequency therapy equipment. Stop using the device immediately and follow manufacturer instructions.

Olympus
Additional IFU
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Health & Personal Care
HIGH
FDA DEVICE

Olympus BF-H1100 Bronchovideoscope Recall 1,867 Units Overseas in 2025

Olympus BF-H1100 bronchovideoscopes sold nationwide in the US were recalled. The recall updates the IFU to clarify safe use with laser, argon plasma coagulation, and high-frequency therapy equipment. Stop using the device immediately and follow the manufacturer’s recall instructions.

Olympus
Additional IFU
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Brand Statistics

Total Recalls
11
Pages
1