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Aomori Olympus Recalls
113 recalls on record · February 17, 2021 to September 13, 2023 · Medical Devices
Recalls by year
21
23
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
September 13, 2023Medical DevicesFDA
Aomori Olympus Co., Ltd. recalls Reusable distal attachments Models: MH-462, MH-463, MH-464, MH-465, MH-466, MH-483, MH-587, MH-588(US), MH-589, MH-590
Hazard: The Distal Attachment contain di-2-ethylhexyl phthalate (DEHP), which exceeds the permissible exposure level calculated according to ISO 10993-17: 2002
September 13, 2023Medical DevicesFDA
Aomori Olympus Co., Ltd. recalls Olympus Distal Attachment (in Olympus Disposable EMR Kit)- Designed to be attached to the distal end of the endoscope.
Hazard: The Distal Attachment contain di-2-ethylhexyl phthalate (DEHP), which exceeds the permissible exposure level calculated according to ISO 10993-17: 2002
February 17, 2021Medical DevicesFDA
Aomori Olympus Co., Ltd. recalls CRESCENT SNARE, model no. SD-221U-25 - Product Usage: Used with endoscopes to electrosurgically resect tissue within the
Hazard: Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.
February 17, 2021Medical DevicesFDA
Aomori Olympus Co., Ltd. recalls CRESCENT SNARE, model no. SD-221L-25 - Product Usage: Used with endoscopes to electrosurgically resect tissue within the
Hazard: Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.
February 17, 2021Medical DevicesFDA
Aomori Olympus Co., Ltd. recalls NA-200H-8022 22G EZSHOT ASPIRATION NEEDLE, model no. NA-200H-8022 - Product Usage: Used with ultrasound endoscopes for u
Hazard: Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.
February 17, 2021Medical DevicesFDA
Aomori Olympus Co., Ltd. recalls MAJ-247 SINGLE USE 30MM REPLACEMENT BASKET, model no. MAJ-247 - Product Usage: REPLACEMENT BASKET for BML-3Q Mechanical
Hazard: Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.
February 17, 2021Medical DevicesFDA
Aomori Olympus Co., Ltd. recalls MAJ-244 SINGLE USE 30MM REPLACEMENT BASKET, model no. MAJ-244 - Product Usage: REPLACEMENT BASKET for BML-3Q Mechanical
Hazard: Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.
February 17, 2021Medical DevicesFDA
Aomori Olympus Co., Ltd. recalls PBD-203-0710 BILIARY STENT, model no. PBD-203-0710 -Product Usage: Used with endoscopes for endoscopic retrograde biliar
Hazard: Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.
February 17, 2021Medical DevicesFDA
Aomori Olympus Co., Ltd. recalls PBD-203-0707 BILIARY STENT, model no. PBD-203-0707 -Product Usage: Used with endoscopes for endoscopic retrograde biliar
Hazard: Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.
February 17, 2021Medical DevicesFDA
Aomori Olympus Co., Ltd. recalls PBD-203-0704 BILIARY STENT, model no. PBD-203-0704 -Product Usage: Used with endoscopes for endoscopic retrograde biliar
Hazard: Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.
February 17, 2021Medical DevicesFDA
Aomori Olympus Co., Ltd. recalls PBD-203-0703 BILIARY STENT, model no. PBD-203-0703 - Product Usage: Used with endoscopes for endoscopic retrograde bilia
Hazard: Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.
February 17, 2021Medical DevicesFDA
Aomori Olympus Co., Ltd. recalls NA-201SX-4022-C ASPIRATION NEEDLE ViziShot 22G w/o stylet, model no. NA-201SX-4022-C - Product Usage: Used with ultrasou
Hazard: Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.
February 17, 2021Medical DevicesFDA
Aomori Olympus Co., Ltd. recalls NA-201SX-4022-B ASPIRATION NEEDLE ViziShot 22G, model no. NA-201SX-4022-B - Product Usage: Used with ultrasound endoscop
Hazard: Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.
February 17, 2021Medical DevicesFDA
Aomori Olympus Co., Ltd. recalls NA-201SX-4022-ASPIRATION NEEDLE VIZISHOT 22G, model no. NA-201SX-4022-A - Product Usage: Used with ultrasound endoscopes
Hazard: Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.
February 17, 2021Medical DevicesFDA
Aomori Olympus Co., Ltd. recalls NA-201SX-4021 ASPIRATION NEEDLE VIZISHOT 21G, model no. NA-201SX-4021 - Product Usage: Used with ultrasound endoscopes f
Hazard: Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.
February 17, 2021Medical DevicesFDA
Aomori Olympus Co., Ltd. recalls NA-601D-1519 ASPIRATION NEEDLE, model no. NA-601D-1519 - Product Usage: Used with endoscopes to collect cells or tissue
Hazard: Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.
February 17, 2021Medical DevicesFDA
Aomori Olympus Co., Ltd. recalls NA-411D-1521 ASPIRATION NEEDLE, model no. NA-411D-1521 - Product Usage: Used with endoscopes to collect cells or tissue
Hazard: Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.
February 17, 2021Medical DevicesFDA
Aomori Olympus Co., Ltd. recalls NA-411D-1321 ASPIRATION NEEDLE, model no. NA-411D-1321 - Product Usage: Used with endoscopes to collect cells or tissue
Hazard: Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.
February 17, 2021Medical DevicesFDA
Aomori Olympus Co., Ltd. recalls NA-401D-1521 ASPIRATION NEEDLE, model no. NA-401D-1521 - Product Usage: Used with endoscopes to collect cells or tissue
Hazard: Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.
February 17, 2021Medical DevicesFDA
Aomori Olympus Co., Ltd. recalls NA-401D-1321 ASPIRATION NEEDLE, model no. NA-401D-1321 - Product Usage: Used with endoscopes to collect cells or tissue
Hazard: Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.
February 17, 2021Medical DevicesFDA
Aomori Olympus Co., Ltd. recalls K-204 GUIDE SHEATH KIT 2.6MM, model no. K-204 - Product Usage: Used with endoscopes to collect cells or tissue specimens
Hazard: Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.
February 17, 2021Medical DevicesFDA
Aomori Olympus Co., Ltd. recalls K-203 GUIDE SHEATH KIT 2.6MM, model no. K-203 - Product Usage: Used with endoscopes to collect cells or tissue specimens
Hazard: Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.
February 17, 2021Medical DevicesFDA
Aomori Olympus Co., Ltd. recalls K-202 GUIDE SHEATH KIT 2.0MM, model no. K-202 - Product Usage: Used with endoscopes to collect cells or tissue specimens
Hazard: Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.
February 17, 2021Medical DevicesFDA
Aomori Olympus Co., Ltd. recalls K-201 GUIDE SHEATH KIT 2.0MM, model no. K-201 - Product Usage: Used with endoscopes to collect cells or tissue specimens
Hazard: Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.
February 17, 2021Medical DevicesFDA
Aomori Olympus Co., Ltd. recalls NEEDLEMASTER 1.8MMx 26G LOWER, model no. NM-610U-1826 - Product Usage: Used with endoscopes to perform endoscopic vascul
Hazard: Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.
February 17, 2021Medical DevicesFDA
Aomori Olympus Co., Ltd. recalls NEEDLEMASTER 6MMx 25G LOWER, model no. NM-610U-0625 - Product Usage: Used with endoscopes to perform endoscopic vascular
Hazard: Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.
February 17, 2021Medical DevicesFDA
Aomori Olympus Co., Ltd. recalls NEEDLEMASTER 6MMx 23G LOWER, model no. NM-610U-0623 - Product Usage: Used with endoscopes to perform endoscopic vascular
Hazard: Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.
February 17, 2021Medical DevicesFDA
Aomori Olympus Co., Ltd. recalls NEEDLEMASTER 5MMx 25G LOWER, model no. NM-610U-0525 - Product Usage: Used with endoscopes to perform endoscopic vascular
Hazard: Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.
February 17, 2021Medical DevicesFDA
Aomori Olympus Co., Ltd. recalls NEEDLEMASTER 3MMx 23G LOWER, model no. NM-610U-0523 - Product Usage: Used with endoscopes to perform endoscopic vascular
Hazard: Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.
February 17, 2021Medical DevicesFDA
Aomori Olympus Co., Ltd. recalls NEEDLEMASTER 4MMx 26G LOWER, model no. NM-610U-0426 - Product Usage: Used with endoscopes to perform endoscopic vascular
Hazard: Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.