Olympus Corporation of the Americas Recalls

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

Health & Personal Care
HIGH
FDA DEVICE

Olympus Recall: 93 PKS Cutting Forceps Over Welding Defects (2026)

Olympus Corporation of the Americas recalled 93 PKS Cutting Forceps worldwide due to welding defects that can cause the jaw to break during clinical use. The issue involves Model 3005PK and UDI 00821925036000. Action is required immediately and providers should follow recall instructions.

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

Olympus PKS Cutting Forceps 920000PK Recalled Worldwide in 2026 for Welding Defects

Olympus recalls 7 PKS Cutting Forceps worldwide because welded components may fail. The devices are used with a 5mm cannula and an electrosurgical generator. Stop using the device and follow the manufacturer’s recall instructions. Healthcare facilities should verify device details and consult Olympus for replacement options.

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

Olympus HALO PKS Cutting Forceps HACF0533 Recalled for Jaw Breakage; 2,648 Units Worldwide (2026)

Olympus Corporation of the Americas is recalling 2,648 HALO PKS Cutting Forceps HACF0533 sold to hospitals and clinics worldwide. The jaw can break during surgical use due to a supplier welding-validation issue. Healthcare facilities should stop using the device immediately and follow Olympus recall instructions for disposition.

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

Olympus Everest Bipolar Cutting Forceps 3005 Recalled for Jaw Break Risk in 2026

Olympus Corporation of the Americas is recalling 106 Everest Bipolar Cutting Forceps worldwide. The devices can have welding defects that may cause the jaw to break during use. Stop using immediately and contact Olympus or your healthcare provider for instructions.

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

Olympus PK Cutting Forceps Recall 444 Units Worldwide Over Welding Defect (2026)

Olympus Corporation of the Americas is recalling 444 PK-CF0533 cutting forceps distributed worldwide. The devices may have welding defects that can cause the jaw to break during surgery. Stop using the device and follow recall instructions from Olympus or your healthcare provider.

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

Olympus PKS Cutting Forceps 920005PK Recalled for Jaw Break Risk (2026)

Olympus Corporation of the Americas recalled 326 PKS Cutting Forceps worldwide. The devices may have welding defects that cause the jaw to break during use. Stop using the device immediately and follow the recall instructions provided by Olympus.

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

Olympus OER-Pro Endoscope Reprocessor Recall for 3,354 Units Over MAJ-1443/1444 Compatibility (2026)

Olympus Corporation of the Americas recalled 3,354 units of the OER-Pro endoscope reprocessor on February 12, 2026. MAJ-1443 and MAJ-1444 are no longer reprocessing compatible with the OER-Pro and OER-Elite automated endoscope reprocessors. Hospitals and clinics should stop using the device immediately and follow the manufacturer’s recall instructions.

Olympus Corporation of the Americas
The MAJ-1443
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Health & Personal Care
HIGH
FDA DEVICE

Olympus Endoscope Reprocessor OER-Elite Recall Affects 2,929 Units (2026)

Olympus Corporation of the Americas is recalling 2,929 units of the OER-Elite Endoscope Reprocessor in the United States. The MAJ-1443 and MAJ-1444 modules are no longer reprocessing compatible with the OER-Pro and OER-Elite systems. Hospitals and healthcare providers should stop using the affected devices immediately and follow the recall instructions issued by Olympus.

Olympus Corporation of the Americas
The MAJ-1443
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Health & Personal Care
HIGH
FDA DEVICE

Olympus MAJ-1444 Endoscope Air/Water Valve Recall 2026 for 89,579 Units

Olympus Corporation of the Americas is recalling 89,579 MAJ-1444 endoscope air/water valves distributed nationwide in the United States. The MAJ-1443 and MAJ-1444 are no longer reprocessing compatible with the OER-Pro and OER-Elite automated endoscope reprocessors. Healthcare facilities should stop using the devices immediately and follow the manufacturer’s recall instructions.

Olympus Corporation of the Americas
The MAJ-1443
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Health & Personal Care
HIGH
FDA DEVICE

Olympus MAJ-1443/MAJ-1444 Endoscope Suction Valves Recalled in 2026

Olympus Corporation of the Americas recalls 47,383 MAJ-1443 and MAJ-1444 endoscope suction valves distributed nationwide in the United States. The valves are no longer reprocessing compatible with the OER-Pro and OER-Elite automated endoscope reprocessors. Hospitals and clinics should stop using the valves immediately and follow the manufacturer’s recall instructions.

Olympus Corporation of the Americas
The MAJ-1443
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Health & Personal Care
HIGH
FDA DEVICE

Olympus Insufflation Unit Recalled Due to Software Hazard

Olympus Corporation recalled 18 High Flow Insufflation Units on January 16, 2026, due to a software issue that can cause overpressure events. The recall affects model number UHI, which is used for laparoscopic procedures. Healthcare providers and patients must stop using the device immediately.

Olympus Corporation of the Americas
Issue with
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Health & Personal Care
HIGH
FDA DEVICE

Olympus Insufflation Unit Recalled Due to Overpressure Hazard

Olympus Corporation recalled 744 High Flow Insufflation Units on January 16, 2026. A software algorithm issue may lead to overpressure events during use. Patients and healthcare providers must stop using the device immediately.

Olympus Corporation of the Americas
Issue with
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Health & Personal Care
HIGH
FDA DEVICE

Olympus Insufflation Unit Recalled Over Software Malfunction

Olympus Corporation recalled 485 units of the High Flow Insufflation Unit, Model UHI-3, on January 16, 2026. The recall follows reports of a software algorithm issue that may cause overpressure events. Patients and healthcare providers must stop using the device immediately.

Olympus Corporation of the Americas
Issue with
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Health & Personal Care
HIGH
FDA DEVICE

Olympus Sphincterotome Recalled Due to Deformation Risk

Olympus Corporation recalled 1,474 units of the Single Use 3-Lumen Sphincterotome V on January 7, 2026. The devices may deform and lose performance due to improper thermoforming. Healthcare providers and patients must stop using these instruments immediately.

Olympus Corporation of the Americas
Devices which
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Health & Personal Care
HIGH
FDA DEVICE

Olympus Recalls Sphincterotome Over Performance Risks

Olympus Corporation of the Americas recalled 5,946 single use sphincterotomes on January 7, 2026. The devices may deform and lose performance due to improper thermoforming. Healthcare providers and patients must cease use immediately to avoid potential hazards.

Olympus Corporation of the Americas
Devices which
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Health & Personal Care
HIGH
FDA DEVICE

Olympus Recalls Sphincterotome Over Deformation Risk

Olympus Corporation of the Americas recalled 93 units of the Single Use 3-Lumen Sphincterotome V on January 7, 2026. The devices may deform and lose performance due to a manufacturing flaw. Healthcare providers and patients should stop using the device immediately and follow recall instructions.

Olympus Corporation of the Americas
Devices which
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Health & Personal Care
HIGH
FDA DEVICE

Olympus Recalls Sphincterotome Due to Risk of Deformation

Olympus Corporation of the Americas recalled 2,344 units of the Single Use 3-Lumen Sphincterotome V on January 7, 2026. The devices may deform due to improper thermoforming, leading to performance issues. This recall affects units distributed worldwide, including all U.S. states.

Olympus Corporation of the Americas
Devices which
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Health & Personal Care
HIGH
FDA DEVICE

Olympus Sphincterotome Recalled Due to Performance Risks

Olympus Corporation recalled 86,303 units of the Single Use 3-Lumen Sphincterotome V on January 7, 2026. The devices may deform and lose performance due to a manufacturing issue. This recall affects devices distributed worldwide, including 1,803 units in the U.S.

Olympus Corporation of the Americas
Devices which
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Brand Statistics

Total Recalls
103
Pages
6