Aomori Olympus Co., Ltd.
70 recalls on record · Latest: Sep 13, 2023
FDA Devices Moderate Sep 13, 2023
Olympus Distal Attachment (in Olympus Disposable EMR Kit)- Designed to be attached to the distal end of the endoscope. Disposable EMR Kit: K-001, K-…
FDA Devices Moderate Feb 17, 2021
INJECTOR FORCEMAX 25G 2.5MM, model no. NM-400U-0425 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment of esopha…
FDA Devices Moderate Feb 17, 2021
KD-611L ELECTROSURGICAL KNIFE, model no. KD-611L - Product Usage: Used with endoscopes and electrosurgical units to cut tissue using high-frequency c…
FDA Devices Moderate Feb 17, 2021
K-202 GUIDE SHEATH KIT 2.0MM, model no. K-202 - Product Usage: Used with endoscopes to collect cells or tissue specimens in the respiratory organs.
FDA Devices Moderate Feb 17, 2021
NEEDLEMASTER 3MMx 23G LOWER, model no. NM-610U-0323 - Product Usage: Used with endoscopes to perform endoscopic vascular or submucosal injection in t…
FDA Devices Moderate Feb 17, 2021
SD-230U-20 ELECTROSURGICAL SNARE, model no. SD-230U-20 - Product Usage: Used with endoscopes to electrosurgically resect tissue within the digestive …
FDA Devices Moderate Feb 17, 2021
B7-2LA BALLOON CATHETER 13MM DIA 3.2, model no. B7-2LA - Product Usage: Used with endoscopes for injection of contrast medium or other medical fluid …
FDA Devices Moderate Feb 17, 2021
INJECTOR FORCEMAX UP 2.8MMCH 23G 6MM, model no. NM-400L-0623 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment …
FDA Devices Moderate Feb 17, 2021
INJECTOR FORCEMAX UP 2.8MMCH 25G 6MM, model no. NM-400L-0625 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment …
FDA Devices Moderate Feb 17, 2021
INJECTOR FORCEMAX UP 2.8MMCH 21G 6MM, model no. NM-400L-0621 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment …
FDA Devices Moderate Feb 17, 2021
PR-V614M 2-LUMEN CANNULA, model no. PR-V614M - Product Usage: Used with endoscopes to inject contrast medium in the biliary or pancreatic duct.
FDA Devices Moderate Feb 17, 2021
KD-620UR ELECTROSURGICAL SNARE, model no. KD-620UR - Product Usage: Used with endoscopes and electrosurgical units to cut tissue using high-frequency…
FDA Devices Moderate Feb 17, 2021
INJECTOR FORCEMAX LOWER 25G 6MM, model no. NM-400U-0625 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment of es…
FDA Devices Moderate Feb 17, 2021
INJECTOR FORCEMAX LOWER 23G 3MM, model no. NM-400U-0323 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment of es…
FDA Devices Moderate Feb 17, 2021
B-V233P-A 3-LUMEN EXTRACTION BALLOON V, model no. B-V233P-A - Product Usage: Used with endoscopes to endoscopically remove stones such as calculi, pa…
FDA Devices Moderate Feb 17, 2021
INJECTOR FORCEMAX UP 2.8MMCH 25G 4MM, model no. NM-400L-0425 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment …
FDA Devices Moderate Feb 17, 2021
INJECTOR FORCEMAX SIF 270CM 23G 4MM, model no. NM-401L-0423 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment o…
FDA Devices Moderate Feb 17, 2021
INJECTOR FORCEMAX UP 2.8MMCH 23G 6MM, model no. NM-400L-0623 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment …
FDA Devices Moderate Feb 17, 2021
NA-401D-1321 ASPIRATION NEEDLE, model no. NA-401D-1321 - Product Usage: Used with endoscopes to collect cells or tissue specimens in the respiratory …
FDA Devices Moderate Feb 17, 2021
KD-655U ELECTROSURGICAL SNARE, model no. KD-655U - Product Usage: Used with endoscopes and electrosurgical units to cut tissue using high-frequency c…
FDA Devices Moderate Feb 17, 2021
NA-201SX-4022-B ASPIRATION NEEDLE ViziShot 22G, model no. NA-201SX-4022-B - Product Usage: Used with ultrasound endoscopes for ultrasound guided fine…
FDA Devices Moderate Feb 17, 2021
INJECTOR FORCEMAX UP 2.8MMCH 21G 6MM, model no. NM-400L-0621 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment …
FDA Devices Moderate Feb 17, 2021
NEEDLEMASTER 3MMx 23G LOWER, model no. NM-610L-0523 - Product Usage: Used with endoscopes to perform endoscopic vascular or submucosal injection in t…
FDA Devices Moderate Feb 17, 2021
INJECTOR FORCEMAX SIF 270CM 23G 4MM, model no. NM-400Y-0423 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment o…
FDA Devices Moderate Feb 17, 2021
NEEDLEMASTER 6MMx 23G LOWER, model no. NM-610U-0623 - Product Usage: Used with endoscopes to perform endoscopic vascular or submucosal injection in t…
FDA Devices Moderate Feb 17, 2021
NEEDLEMASTER 5MMx 21G UPPER, model no. NM-610L-0521 - Product Usage: Used with endoscopes to perform endoscopic vascular or submucosal injection in t…
FDA Devices Moderate Feb 17, 2021
K-203 GUIDE SHEATH Kit 2.6MM, model no. K-203 - Product Usage: Used with endoscopes to collect cells or tissue specimens in the respiratory organs.
FDA Devices Moderate Feb 17, 2021
INJECTOR FORCEMAX LOWER 23G 6MM, model no. NM-400U-0623 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment of es…
FDA Devices Moderate Feb 17, 2021
INJECTOR FORCEMAX LOWER 23G 3MM, model no. NM-400U-0323 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment of es…
FDA Devices Moderate Feb 17, 2021
K-204 GUIDE SHEATH Kit 2.6MM, model no K-204 - Product Usage: Used with endoscopes to collect cells or tissue specimens in the respiratory organs.
FDA Devices Moderate Feb 17, 2021
INJECTOR FORCEMAX SIF 270CM 23G 4MM, model no. NM-400Y-0423 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment o…
FDA Devices Moderate Feb 17, 2021
KD-620LR ELECTROSURGICAL SNARE, model no. KD-620LR - Product Usage: Used with endoscopes and electrosurgical units to cut tissue using high-frequency…
FDA Devices Moderate Feb 17, 2021
MAJ-247 SINGLE USE 30MM REPLACEMENT BASKET, model no. MAJ-247 - Product Usage: REPLACEMENT BASKET for BML-3Q Mechanical Lithotripter.
FDA Devices Moderate Feb 17, 2021
INJECTOR FORCEMAX UP 2.8MMCH 25G 5MM, model no. NM-400L-0525 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment …
FDA Devices Moderate Feb 17, 2021
SD-240U-15 ELECTROSURGICAL SNARE, model no. SD-240U-15 - Product Usage: Used with endoscopes to electrosurgically resect tissue within the digestive …
FDA Devices Moderate Feb 17, 2021
K-203 GUIDE SHEATH KIT 2.6MM, model no. K-203 - Product Usage: Used with endoscopes to collect cells or tissue specimens in the respiratory organs.
FDA Devices Moderate Feb 17, 2021
PBD-203-0703 BILIARY STENT, model no. PBD-203-0703 - Product Usage: Used with endoscopes for endoscopic retrograde biliary drainage.
FDA Devices Moderate Feb 17, 2021
NEEDLEMASTER 5MMx 25G UPPER, model no. NM-610L-0525 - Product Usage: Used with endoscopes to perform endoscopic vascular or submucosal injection in t…
FDA Devices Moderate Feb 17, 2021
K-201 GUIDE SHEATH Kit 2.0MM, model no. K-201 - Product Usage: Used with endoscopes to collect cells or tissue specimens in the respiratory organs.
FDA Devices Moderate Feb 17, 2021
INJECTOR FORCEMAX UP 2.8MMCH 23G 4MM, model no. NM-400L-0423 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment …
FDA Devices Moderate Feb 17, 2021
INJECTOR FORCEMAX LOWER 25G 5MM, model no. NM-400U-0525 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment of es…
FDA Devices Moderate Feb 17, 2021
B5-2C BALLOON CATHETER 11MM DIA 2.0; Model No. B5-2C - Product Usage: Used with endoscopes to inject contrast medium or other medical fluid into the …
FDA Devices Moderate Feb 17, 2021
K-201 GUIDE SHEATH KIT 2.0MM, model no. K-201 - Product Usage: Used with endoscopes to collect cells or tissue specimens in the respiratory organs.
FDA Devices Moderate Feb 17, 2021
INJECTOR FORCEMAX LOWER 25G 5MM, model no. NM-400U-0525 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment of es…
FDA Devices Moderate Feb 17, 2021
KD-655L ELECTROSURGICAL SNARE, model no. KD-655L - Product Usage: Used with endoscopes and electrosurgical units to cut tissue using high-frequency c…
FDA Devices Moderate Feb 17, 2021
NA-401D-1521 ASPIRATION NEEDLE, model no. NA-401D-1521 - Product Usage: Used with endoscopes to collect cells or tissue specimens in the respiratory …
FDA Devices Moderate Feb 17, 2021
PBD-203-0707 BILIARY STENT, model no. PBD-203-0707 -Product Usage: Used with endoscopes for endoscopic retrograde biliary drainage.
FDA Devices Moderate Feb 17, 2021
INJECTOR FORCEMAX UP 2.8MMCH 25G 4MM, model no. NM-400L-0425 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment …
FDA Devices Moderate Feb 17, 2021
NEEDLEMASTER 3MMx 26G LOWER, model no. NM-610U-0326 - Product Usage: Used with endoscopes to perform endoscopic vascular or submucosal injection in t…
FDA Devices Moderate Feb 17, 2021