Olympus Corporation of the Americas Recalls

115 recalls found for Olympus Corporation of the Americas. Check if any of your products are affected.

Health & Personal Care
HIGH
FDA DEVICE

OLYMPUS BF-1T150 Bronchoscope Recall in 2025 for Updated IFU on Safe Use

Olympus Corporation of the Americas recalled 1,990 BF-1T150 bronchoscopes distributed nationwide to healthcare providers. The recall updates the IFU to clarify safe use with laser, argon plasma coagulation and high-frequency therapy equipment. Healthcare facilities should stop using the devices immediately and follow the manufacturer’s recall instructions.

Olympus Corporation of the Americas
Additional IFU
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Health & Personal Care
HIGH
FDA DEVICE

Olympus BF-PE2 Bronchoscope Recall Expands with 4,289 Units Aboard Outside US

Olympus Corporation of the Americas confirms a Class I recall of the BRONCHOFIBERSCOPE BF TYPE PE2. The recall covers 2 units in the US and 4,289 units outside the US. Updated IFU guidance aims to clarify safe use with laser, argon plasma coagulation and high-frequency therapy equipment.

Olympus Corporation of the Americas
Additional IFU
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Health & Personal Care
HIGH
FDA DEVICE

Olympus BF-Q180-AC Bronchoscope Recall Due to Safety Issues - Stop Using Now

Olympus recalled 395 EVIS EXERA II bronchoscopes after updates revealed safety concerns. The bronchoscope's instructions for use with laser and coagulation equipment lacked clarity, posing high risks during procedures. Patients and healthcare providers must stop using this device and follow recall instructions immediately.

Olympus Corporation of the Americas
Additional IFU
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Health & Personal Care
HIGH
FDA DEVICE

Olympus BF-H190 Bronchovideoscope Recall Expanded for IFU Updates in 2025

Olympus Corporation of the Americas recalls 5,221 units sold in the U.S. and 4,321 units overseas. The recall covers the EVIS EXERA III BRONCHOVIDEOSCOPE BF-H190. It flags updated instructions for safe use with laser, argon plasma coagulation and high-frequency therapy equipment. Patients and healthcare providers should stop using the device immediately and follow recall instructions.

Olympus Corporation of the Americas
Additional IFU
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Health & Personal Care
HIGH
FDA DEVICE

Olympus EVIS EXERA II BF-P180 Bronchovideoscope Recalled; 3,250 Units Affected Worldwide (2025)

Olympus Corporation of the Americas recalls 3,250 EVIS EXERA II BF-P180 Bronchovideoscopes sold in the United States and internationally. The recall updates the instructions for use to clarify safe and effective use with laser, argon plasma coagulation, and high-frequency therapy equipment. Healthcare providers should stop using the device immediately and contact Olympus for instructions.

Olympus Corporation of the Americas
Additional IFU
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Health & Personal Care
HIGH
FDA DEVICE

Olympus BF-TE2 Bronchofiberscope Recall for IFU Updates in 2025

Olympus Corporation of the Americas recalls the BF-TE2 bronchofiberscope distributed nationwide in the United States. The recall updates the Instructions for Use 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 Corporation of the Americas
Additional IFU
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Health & Personal Care
HIGH
FDA DEVICE

Olympus BF-P150 Bronchoscope Recall Expanded Over IFU Clarifications (2025)

Olympus Corporation of the Americas recalls its BF-P150 bronchoscope after updates to the instruction for use. The recall covers 1,019 units outside the U.S. Distribution was nationwide in the U.S. The agency classifies this as a high-hazard issue.

Olympus Corporation of the Americas
Additional IFU
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Health & Personal Care
HIGH
FDA DEVICE

Olympus BF-XT190 Bronchovideoscope Recall for IFU Updates Over Laser and HF Therapy Use

Olympus Corporation of the Americas recalls 361 units in the US and 258 units overseas as of September 11, 2025. The recall targets the EVIS EXERA b Bronchovideoscope BF-XT190. The update adds safety instructions for using bronchoscopes with laser, argon plasma coagulation, and high-frequency therapy equipment. Patients and healthcare providers should stop using the device immediately and follow a

Olympus Corporation of the Americas
Additional IFU
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Health & Personal Care
HIGH
FDA DEVICE

Olympus BF-1TH1100 Bronchoscope Recall Expanded for IFU Clarifications (2025)—High Risk

Olympus Corporation of the Americas reports an active recall for the BRONCHOVIDEOSCOPE BF-1TH1100. The recall concerns additional IFU updates for safe use with laser, argon plasma coagulation, and high-frequency therapy equipment. The company urges stopping use and following recall instructions.

Olympus Corporation of the Americas
Additional IFU
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Health & Personal Care
HIGH
FDA DEVICE

Olympus EVIS EXERA III BF-Q190 Bronchovideoscope Recall Expands in 2025 for IFU Updates

Olympus Corporation of the Americas recalled 916 BF-Q190 bronchovideoscopes in the United States and 1,402 outside the US. The recall seeks 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 guidance.

Olympus Corporation of the Americas
Additional IFU
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Health & Personal Care
HIGH
FDA DEVICE

Olympus BF-XT160 Bronchoscope Recall Due to High Hazard Risk — 262 Units Affected

Olympus recalled 262 units of the BF-XT160 bronchoscope after concerns regarding its safe use with laser and high-frequency therapy equipment. Additional instructions for use (IFU) updates clarify potential hazards. Healthcare providers and patients must cease use immediately and follow the manufacturer's recall instructions.

Olympus Corporation of the Americas
Additional IFU
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Health & Personal Care
HIGH
FDA DEVICE

Olympus ViziShot 2FLEX Biopsy Device Recalled for Deformed Tips in 103,731 Units

Olympus Corp of the Americas recalled 103,731 ViziShot 2FLEX single-use aspiration needles worldwide after officials flagged potential undetected, deformed atraumatic tips. The recall covers the NA-U403SX-4019 model. Healthcare providers must halt use immediately and follow manufacturer instructions for recall. Manufacturers say notification was by letter.

Olympus Corporation of the Americas
Potential for
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Health & Personal Care
HIGH
FDA DEVICE

Olympus Cystoscope Outer Sheath Recalled Over Laser Incompatibility

Olympus Corporation of the Americas recalled 633 units of the Cystoscope Outer Sheath, Model WA22810A on September 13, 2024. The recall occurred due to potential device damage when used with a GreenLight Laser for BPH therapy. Healthcare providers and patients must stop using the device immediately and follow recall instructions.

Olympus Corporation of the Americas
Product being
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Health & Personal Care
HIGH
FDA DEVICE

Olympus Recalls Electrosurgical Knife Over Burning Risk

Olympus Corporation of the Americas recalled the Single Use Electrosurgical Knife KD-640L on February 17, 2024. The recall follows reports of overheating and potential tip breakage during surgery. Healthcare providers and patients must stop using the device immediately to avoid injuries.

Olympus Corporation of the Americas
A deterioration
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Health & Personal Care
HIGH
FDA DEVICE

Olympus Recalls Electrosurgical Knife Over Burn Hazard

Olympus Corporation recalled 3,361 Single Use Electrosurgical Knives on February 17, 2024, due to burn risks from tip breakage. The recall affects model KD-645L, distributed nationwide. The defective knives may overheat and deteriorate during use, posing serious safety risks.

Olympus Corporation of the Americas
A deterioration
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Brand Statistics

Total Recalls
115
Pages
6

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