Health & Personal Care
HIGH
FDA DEVICE
Olympus Recalls Sphincterotome Due to Potential Deformity Hazard
Devices which did not undergo thermoforming could deform and lose performance.
Olympus Corporation of the Americas
Devices which
Brand hub
Olympus Corporation of the Americas Recalls
115 recalls found for Olympus Corporation of the Americas. Check current safety alerts and related brands before using affected products.
- Active recalls
- 115
- Pages
- 6
Health & Personal Care
HIGH
FDA DEVICE
Olympus ShockPulse-SE SPL-S Lithotripsy System Recalled 1,082 Units in 2026
Ongoing investigations identified additional instances of the device Generator remaining in a blinking phase waiting to recognize the transducer. Damage to the transducer plug and/or generator receptacle may cause these issues.
Olympus Corporation of the Americas
Ongoing investigations
Health & Personal Care
HIGH
FDA DEVICE
Olympus ShockPulse-SE Lithotripsy System SPL-G Recall Impacts 1,684 Units Worldwide (2025)
Ongoing investigations identified additional instances of the device Generator remaining in a blinking phase waiting to recognize the transducer. Damage to the transducer plug and/or generator receptacle may cause these issues.
Olympus Corporation of the Americas
Ongoing investigations
Health & Personal Care
HIGH
FDA DEVICE
Olympus Recalls Inner Sheath Due to Breaking Ceramic Tip Hazard
Complaints of the ceramic tip of the resection sheath breaking have been received.
Olympus Corporation of the Americas
Complaints of
Health & Personal Care
HIGH
FDA DEVICE
Olympus Resection Sheath Recalled Due to Breakage Risk
Complaints of the ceramic tip of the resection sheath breaking have been received.
Olympus Corporation of the Americas
Complaints of
Health & Personal Care
HIGH
FDA DEVICE
Olympus Resection Sheath Recalled Due to Breaking Tips
Complaints of the ceramic tip of the resection sheath breaking have been received.
Olympus Corporation of the Americas
Complaints of
Health & Personal Care
HIGH
FDA DEVICE
Olympus Resection Sheath Recalled Due to Breakage Hazard
Complaints of the ceramic tip of the resection sheath breaking have been received.
Olympus Corporation of the Americas
Complaints of
Health & Personal Care
HIGH
FDA DEVICE
Olympus Recalls Endoscopic Sheath Due to Breakage Risk
Complaints of the ceramic tip of the resection sheath breaking have been received.
Olympus Corporation of the Americas
Complaints of
Health & Personal Care
HIGH
FDA DEVICE
Olympus Resection Sheath Recalled Due to Ceramic Tip Breakage
Complaints of the ceramic tip of the resection sheath breaking have been received.
Olympus Corporation of the Americas
Complaints of
Health & Personal Care
HIGH
FDA DEVICE
Olympus Resection Sheath Recalled Due to Ceramic Tip Breaking
Complaints of the ceramic tip of the resection sheath breaking have been received.
Olympus Corporation of the Americas
Complaints of
Health & Personal Care
HIGH
FDA DEVICE
Olympus Resection Sheath Recalled Due to Breaking Hazard
Complaints of the ceramic tip of the resection sheath breaking have been received.
Olympus Corporation of the Americas
Complaints of
Health & Personal Care
HIGH
FDA DEVICE
Olympus Resection Sheath Recalled Due to Breaking Tip Hazard
Olympus Corporation of the Americas recalled 2,626 units of its Resection Sheath on November 11, 2025. The ceramic tip of the sheath may break during use, posing a high risk to patients. Healthcare providers and patients must stop using the device immediately.
Olympus Corporation of the Americas
Complaints of
Health & Personal Care
HIGH
FDA DEVICE
Olympus Inner Sheath Recalled Due to Breakage Risk
Olympus Corporation of the Americas recalled the Inner Sheath 21 Fr., Model No. A2660T, on November 11, 2025. The recall follows reports of the ceramic tip breaking during use. Patients and healthcare providers should stop using the device immediately.
Olympus Corporation of the Americas
Complaints of
Health & Personal Care
HIGH
FDA DEVICE
Olympus Resection Sheath Recalled Due to Breaking Ceramic Tip
Complaints of the ceramic tip of the resection sheath breaking have been received.
Olympus Corporation of the Americas
Complaints of
Health & Personal Care
HIGH
FDA DEVICE
Olympus Resection Inner Sheath Recalled Due to Breakage Risk
Complaints of the ceramic tip of the resection sheath breaking have been received.
Olympus Corporation of the Americas
Complaints of
Health & Personal Care
HIGH
FDA DEVICE
Olympus Resection Sheath Recalled Due to Breakage Risk
Complaints of the ceramic tip of the resection sheath breaking have been received.
Olympus Corporation of the Americas
Complaints of
Health & Personal Care
HIGH
FDA DEVICE
Olympus Recalled Endoscopic Sheath Due to Breakage Risk
Complaints of the ceramic tip of the resection sheath breaking have been received.
Olympus Corporation of the Americas
Complaints of
Health & Personal Care
HIGH
FDA DEVICE
Olympus Resection Inner Sheath Recalled Due to Breakage Risk
Complaints of the ceramic tip of the resection sheath breaking have been received.
Olympus Corporation of the Americas
Complaints of
Health & Personal Care
HIGH
FDA DEVICE
Olympus Inner Sheath Recalled Over Breaking Ceramic Tip Hazard
Complaints of the ceramic tip of the resection sheath breaking have been received.
Olympus Corporation of the Americas
Complaints of
Health & Personal Care
HIGH
FDA DEVICE
Olympus Resection Sheath Recalled Due to Ceramic Tip Hazard
Complaints of the ceramic tip of the resection sheath breaking have been received.
Olympus Corporation of the Americas
Complaints of
Brand Statistics
Total Recalls
115
Pages
6