United StatesOlympus resection sheaths and inner sheaths used for endoscopic diagnosis and treatment in urological and gynecological applications are affected, including Model A22014A (UDI: 04042761020893), Model A22014T (UDI: 04042761020909) and multiple other listed models and UDIs (all lots). The devices were recalled after complaints that the ceramic tip of the resection sheath can break.
What's being recalled
Olympus Resection Sheath. Model No. A22014A and A22014T. for endoscopic diagnosis and treatment in urological applications.
Olympus Resection Inner Sheath, for 26 Fr. Outer Sheath. Model No. A22040A. Resection sheath for urologic applications.
Olympus Resection Inner Sheath for 26 Fr. Outer Sheath. Model No. A22040T. Resection sheath for urologic applications.
Olympus Resection Sheath, 24 Fr; Model No. A22041A. Resection sheath for urologic applications.
Olympus Resection Sheath, 24 Fr., with Deflecting Obturator; Model No. A22041T. Resection sheath for urologic applications.
Olympus Resection Sheath, 26 Fr.; Model No. A22042A. Resection sheath for urologic applications.
Olympus Resection Sheath, 26 Fr. with Deflecting Obturator; Model No. A22042T. Resection sheath for urologic applications.
Olympus Resection Sheath, 28 Fr.; Model No. A22043A. Resection sheath for urologic applications.
Olympus Resection Sheath, 28 Fr. with Deflecting Obturator. Model No. A22043T. Resection sheath for urologic applications.
Olympus Inner Sheath; Model No. A2660. for endoscopic diagnosis and treatment in urological applications.
Olympus Resection Sheath, 8 mm. Model No. A42011A. Resection sheath for gynecological applications.
Olympus Inner Sheath. Model No. A4741. for endoscopic diagnosis and treatment in gynecological applications.
Olympus Inner Sheath, Long; Model No. WA22017A. Inner sheath for urological and gynecological applications.
Olympus Inner Sheath, Long; Model No. WA22017T. Inner sheath for urological and gynecological applications.
Olympus Resection Sheath; Model No. A2666. Resection sheath for urologic applications.
And 5 more products.
Recalling firm: Olympus Corporation of the Americas, Center Valley, PA, United States.
How to identify it
Model: A22014A (UDI: 04042761020893) and A22014T (UDI: 04042761020909). All lots. Model No. A22040A; UDI: 04042761029339; All Lots. Model No. A22040T; UDI: 04042761029360; All Lots. Model No. Model No. A22041A; UDI: 04042761020961; All Lots. Model No. A22041T; UDI: 04042761020978; All Lots. Model No. A22042A; UDI: 04042761020985; All Lots. Model No. A22042T; UDI: 04042761020992; All Lots. Model No. A22043A; UDI: 04042761021005; All Lots. Model No. A22043T; UDI: 04042761021012; All Lots. Model No. A2660; UDI: 04042761004176; All Lots. Model No. A42011A; UDI: 04042761023658; All Lots. Model No. A4741; UDI: 04042761006514; All Lots. Model No. WA22017A; UDI: 04042761051514; All Lots. Model No. WA22017T; UDI: 04042761051521; All Lots. Model No. A2666; UDI: 04042761004244; All Lots Model No. A2660T; UDI: 04042761004183; All Lots. Model No. A37004A; UDI: 04042761023092; All Lots. Model No. A2641; UDI: 04042761004060; All Lots. Model No. A2642; UDI: 04042761004084; All Lots. Model No. A2666T; UDI: 04042761004251; All Lots.
The hazard
Complaints of the ceramic tip of the resection sheath breaking have been received.
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
US Nationwide Distribution.
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)