Medical device recalls

39180 federal recalls on file. Federal recalls for medical devices — surgical equipment, monitors, diagnostic tools, implants, home health devices. Sourced from the FDA.

2021-02-17FDA-DeviceAomori Olympus Co., Ltd.Class II
PBD-203-0710 BILIARY STENT, model no. PBD-203-0710 -Product Usage: Used with endoscopes for endoscopic retrograde biliary drainage.
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.
2021-02-17FDA-DeviceAomori Olympus Co., Ltd.Class II
PBD-203-0707 BILIARY STENT, model no. PBD-203-0707 -Product Usage: Used with endoscopes for endoscopic retrograde biliary drainage.
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.
2021-02-17FDA-DeviceAomori Olympus Co., Ltd.Class II
PBD-203-0704 BILIARY STENT, model no. PBD-203-0704 -Product Usage: Used with endoscopes for endoscopic retrograde biliary drainage.
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.
2021-02-17FDA-DeviceAomori Olympus Co., Ltd.Class II
PBD-203-0703 BILIARY STENT, model no. PBD-203-0703 - Product Usage: Used with endoscopes for endoscopic retrograde biliary drainage.
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.
2021-02-17FDA-DeviceAomori Olympus Co., Ltd.Class II
NA-201SX-4022-C ASPIRATION NEEDLE ViziShot 22G w/o stylet, model no. NA-201SX-4022-C - Product Usage: Used with ultrasound endoscopes for ultrasound guided fine needle aspiration of submucosal and extramural lesions of the tracheobronchial tree and esophagus.
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.
2021-02-17FDA-DeviceAomori Olympus Co., Ltd.Class II
NA-201SX-4022-B ASPIRATION NEEDLE ViziShot 22G, model no. NA-201SX-4022-B - Product Usage: Used with ultrasound endoscopes for ultrasound guided fine needle aspiration of submucosal and extramural lesions of the tracheobronchial tree and esophagus.
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.
2021-02-17FDA-DeviceAomori Olympus Co., Ltd.Class II
NA-201SX-4022-ASPIRATION NEEDLE VIZISHOT 22G, model no. NA-201SX-4022-A - Product Usage: Used with ultrasound endoscopes for ultrasound guided fine needle aspiration of submucosal and extramural lesions of the tracheobronchial tree and esophagus.
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.
2021-02-17FDA-DeviceAomori Olympus Co., Ltd.Class II
NA-201SX-4021 ASPIRATION NEEDLE VIZISHOT 21G, model no. NA-201SX-4021 - Product Usage: Used with ultrasound endoscopes for ultrasound guided fine needle aspiration of submucosal and extramural lesions of the tracheobronchial tree and esophagus.
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.
2021-02-17FDA-DeviceAomori Olympus Co., Ltd.Class II
NA-601D-1519 ASPIRATION NEEDLE, model no. NA-601D-1519 - Product Usage: Used with endoscopes to collect cells or tissue specimens in the respiratory organs.
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.
2021-02-17FDA-DeviceAomori Olympus Co., Ltd.Class II
NA-411D-1521 ASPIRATION NEEDLE, model no. NA-411D-1521 - Product Usage: Used with endoscopes to collect cells or tissue specimens in the respiratory organs.
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.
2021-02-17FDA-DeviceAomori Olympus Co., Ltd.Class II
NA-411D-1321 ASPIRATION NEEDLE, model no. NA-411D-1321 - Product Usage: Used with endoscopes to collect cells or tissue specimens in the respiratory organs.
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.
2021-02-17FDA-DeviceAomori Olympus Co., Ltd.Class II
NA-401D-1521 ASPIRATION NEEDLE, model no. NA-401D-1521 - Product Usage: Used with endoscopes to collect cells or tissue specimens in the respiratory organs.
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.
2021-02-17FDA-DeviceAomori Olympus Co., Ltd.Class II
NA-401D-1321 ASPIRATION NEEDLE, model no. NA-401D-1321 - Product Usage: Used with endoscopes to collect cells or tissue specimens in the respiratory organs.
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.
2021-02-17FDA-DeviceAomori Olympus Co., Ltd.Class II
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.
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.
2021-02-17FDA-DeviceAomori Olympus Co., Ltd.Class II
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.
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.
2021-02-17FDA-DeviceAomori Olympus Co., Ltd.Class II
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.
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.
2021-02-17FDA-DeviceAomori Olympus Co., Ltd.Class II
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.
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.
2021-02-17FDA-DeviceAomori Olympus Co., Ltd.Class II
NEEDLEMASTER 1.8MMx 26G LOWER, model no. NM-610U-1826 - Product Usage: Used with endoscopes to perform endoscopic vascular or submucosal injection in the GI tract.
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.
2021-02-17FDA-DeviceAomori Olympus Co., Ltd.Class II
NEEDLEMASTER 6MMx 25G LOWER, model no. NM-610U-0625 - Product Usage: Used with endoscopes to perform endoscopic vascular or submucosal injection in the GI tract.
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.
2021-02-17FDA-DeviceAomori Olympus Co., Ltd.Class II
NEEDLEMASTER 6MMx 23G LOWER, model no. NM-610U-0623 - Product Usage: Used with endoscopes to perform endoscopic vascular or submucosal injection in the GI tract.
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.
2021-02-17FDA-DeviceAomori Olympus Co., Ltd.Class II
NEEDLEMASTER 5MMx 25G LOWER, model no. NM-610U-0525 - Product Usage: Used with endoscopes to perform endoscopic vascular or submucosal injection in the GI tract.
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.
2021-02-17FDA-DeviceAomori Olympus Co., Ltd.Class II
NEEDLEMASTER 3MMx 23G LOWER, model no. NM-610U-0523 - Product Usage: Used with endoscopes to perform endoscopic vascular or submucosal injection in the GI tract.
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.
2021-02-17FDA-DeviceAomori Olympus Co., Ltd.Class II
NEEDLEMASTER 4MMx 26G LOWER, model no. NM-610U-0426 - Product Usage: Used with endoscopes to perform endoscopic vascular or submucosal injection in the GI tract.
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.
2021-02-17FDA-DeviceAomori Olympus Co., Ltd.Class II
NEEDLEMASTER 4MMx 25G LOWER, model no. NM-610U-0425 - Product Usage: Used with endoscopes to perform endoscopic vascular or submucosal injection in the GI tract.
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.
2021-02-17FDA-DeviceAomori Olympus Co., Ltd.Class II
NEEDLEMASTER 4MMx 23G LOWER, model no. NM-610U-0423 - Product Usage: Used with endoscopes to perform endoscopic vascular or submucosal injection in the GI tract.
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.
2021-02-17FDA-DeviceAomori Olympus Co., Ltd.Class II
NEEDLEMASTER 3MMx 26G LOWER, model no. NM-610U-0326 - Product Usage: Used with endoscopes to perform endoscopic vascular or submucosal injection in the GI tract.
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.
2021-02-17FDA-DeviceAomori Olympus Co., Ltd.Class II
NEEDLEMASTER 3MMx 23G LOWER, model no. NM-610U-0323 - Product Usage: Used with endoscopes to perform endoscopic vascular or submucosal injection in the GI tract.
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.
2021-02-17FDA-DeviceAomori Olympus Co., Ltd.Class II
NEEDLEMASTER 6MMx 25G UPPER, model no. NM-610L-0625 - Product Usage: Used with endoscopes to perform endoscopic vascular or submucosal injection in the GI tract.
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.
2021-02-17FDA-DeviceAomori Olympus Co., Ltd.Class II
NEEDLEMASTER 6MMx 23G UPPER, model no. NM-610L-0623 - Product Usage: Used with endoscopes to perform endoscopic vascular or submucosal injection in the GI tract.
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.
2021-02-17FDA-DeviceAomori Olympus Co., Ltd.Class II
NEEDLEMASTER 6MMx 21G UPPER, model no. NM-610L-0621 - Product Usage: Used with endoscopes to perform endoscopic vascular or submucosal injection in the GI tract.
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.

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