Olympus Corporation of the Americas recalled 437 units of the Inner Sheath, Model No. WA22017A, on November 11, 2025. The recall follows complaints of the ceramic tip breaking during use, posing a significant risk to patients. Healthcare providers and patients should cease use immediately and follow the manufacturer’s instructions.
Complaints of the ceramic tip of the resection sheath breaking have been received.
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 recalled product is the Olympus Inner Sheath, Long, Model No. WA22017A. It is designed for urological and gynecological applications. The device was distributed nationwide in the U.S.
The recall stems from reports of the ceramic tip of the resection sheath breaking. This defect can pose serious risks during medical procedures, potentially leading to complications.
There have been multiple complaints regarding the breaking of the ceramic tip. No specific injury or death counts were reported.
Patients and healthcare providers should immediately stop using the Inner Sheath. Follow the recall instructions provided by Olympus Corporation of the Americas and contact your healthcare provider for guidance.
For more information, contact Olympus Corporation of the Americas or visit their official website. Details can also be found on the FDA’s recall page.
Get instant alerts for recalls that affect you. Free forever.
AvKARE recalled Amantadine HCl capsules on February 13, 2026, due to failed dissolution specifications. The recall affects the 100 mg capsules, which may not dissolve properly. Consumers should stop using this product and contact their healthcare provider immediately.
Slate Run Pharmaceuticals recalled Eptifibatide Injection on February 12, 2026. The recall affects all lots of the 75 mg/100 mL vial due to incorrect dosing information. Healthcare providers and consumers must stop using the product immediately.
LEO Pharma Inc. recalled 11,407 units of Adbry injection on February 10, 2026. The recall stems from a lack of assurance of sterility due to particulate matter identified as wool fiber. Consumers should stop using the product immediately and contact their healthcare provider for guidance.
Taro Pharmaceuticals announced a market withdrawal of Diclofenac Sodium, Topical Gel, 3% on January 27, 2026. The withdrawal stems from out of specification viscosity results. Healthcare providers and consumers should stop using the product immediately.
Hitachi Ltd. recalled one unit of its Proton Beam Therapy System on February 6, 2026 due to a software anomaly. The issue may result in positional discrepancies during patient treatment. The recall affects distribution in Texas and Washington D.C.
Hitachi recalled its Proton Beam Therapy System on February 6, 2026, due to a software anomaly that may result in positional discrepancies. The recall affects one unit distributed in Texas and Washington D.C. Healthcare providers and patients must stop using the device immediately.
Fresenius Kabi Compounding recalled 1,057 bags of Acyclovir Sodium Injection on February 5, 2026. The recall stems from a lack of assurance of sterility, posing a high health risk. Healthcare providers should cease use immediately and contact the manufacturer for guidance.
Fresenius Kabi Compounding recalled its vancomycin HCl injection on February 5, 2026, due to a lack of assurance of sterility. This Class II recall affects all lots distributed nationwide. Healthcare providers and consumers must stop using the product immediately.