FDA (Devices) recall action 87074

Aomori Olympus Co., Ltd. recalled 111 products on 2021-02-17

The FDA (Devices) publishes a recall like this one as 111 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 111 pages.

Products: 111
Announced: 2021-02-17
Critical: 0
Units: —

Why these products were recalled

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.

The agency’s own wording, quoted from the enforcement report.

1–25 of 111

HighFDA (Devices)··2021-02-17
Aomori Olympus Recalls Endoscopic Injectors Due to Package Seal Defects
Aomori Olympus is recalling endoscopic injectors because some sterile packages have inadequate seals, posing a risk of infection if non-sterile equipment is used.
Product
INJECTOR FORCEMAX LOWER 25G 6MM, model no. NM-400U-0625 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment of esophageal and gastric varices and for submucosal injection in the digestive tract.
Category
Distribution
0 states
HighFDA (Devices)··2021-02-17
Aomori Olympus Recalls 3-Lumen Extraction Balloon V Due to Seal Defects
Aomori Olympus is recalling 3-Lumen Extraction Balloon V devices because some sterile packages have inadequate seals, posing a risk of infection if used.
Product
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, pancreatic and common bile duct stones.
Category
Distribution
0 states
HighFDA (Devices)··2021-02-17
Aomori Olympus Recalls KD-612U Electrosurgical Snare Due to Seal Defects
Aomori Olympus is recalling KD-612U electrosurgical snares because some sterile packages have inadequate seals, posing a risk of infection if non-sterile equipment is used.
Product
KD-612U ELECTROSURGICAL SNARE, model no. KD-612U - Product Usage: Used with endoscopes and electrosurgical units to cut tissue using high-frequency current within the upper digestive tract.
Category
Distribution
0 states
HighFDA (Devices)··2021-02-17
Aomori Olympus ForceMax Injector Recalled for Inadequate Package Seals
Aomori Olympus is recalling ForceMax injectors because inspection found some sterile packages had inadequate seals, posing an infection risk if non-sterile equipment is used.
Product
INJECTOR FORCEMAX UP 2.8MMCH 21G 4MM, model no. NM-400L-0421 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment of esophageal and gastric varices and for submucosal injection in the digestive tract.
Category
Distribution
0 states
HighFDA (Devices)··2021-02-17
Aomori Olympus Recalls Aspiration Needles Due to Inadequate Package Seals
Aomori Olympus is recalling NA-411D-1321 aspiration needles because inspection found some sterile packages have inadequate seals, posing an infection risk.
Product
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.
Category
Distribution
0 states
HighFDA (Devices)··2021-02-17
Aomori Olympus Recalls 22G EZSHOT Aspiration Needles Due to Seal Defects
Aomori Olympus is recalling 22G EZSHOT aspiration needles because some sterile packages have inadequate seals, posing a risk of infection if used.
Product
NA-200H-8022 22G EZSHOT ASPIRATION NEEDLE, model no. NA-200H-8022 - Product Usage: Used with ultrasound endoscopes for ultrasound guided fine needle aspiration of submucosal and extramural lesions of the gastrointestinal tract.
Category
Distribution
0 states
HighFDA (Devices)··2021-02-17
Aomori Olympus Recalls Electrosurgical Snare Due to Seal Defects
Aomori Olympus is recalling KD-655L electrosurgical snares because some sterile packages have inadequate seals, posing an infection risk.
Product
KD-655L ELECTROSURGICAL SNARE, model no. KD-655L - Product Usage: Used with endoscopes and electrosurgical units to cut tissue using high-frequency current within the upper digestive tract.
Category
Distribution
0 states
HighFDA (Devices)··2021-02-17
Aomori Olympus Recalls Crescent Snare Due to Inadequate Package Seals
Aomori Olympus Co., Ltd. is recalling Crescent Snare models due to inadequate package seals that may compromise sterility and increase infection risk.
Product
CRESCENT SNARE, model no. SD-221L-25 - Product Usage: Used with endoscopes to electrosurgically resect tissue within the digestive tract.
Category
Distribution
0 states
HighFDA (Devices)··2021-02-17
Aomori Olympus Biliary Stent Recalled for Inadequate Package Seals
Aomori Olympus is recalling biliary stents because some sterile packages have inadequate seals, posing a risk of infection if non-sterile equipment is used.
Product
PBD-203-0707 BILIARY STENT, model no. PBD-203-0707 -Product Usage: Used with endoscopes for endoscopic retrograde biliary drainage.
Category
Distribution
0 states
HighFDA (Devices)··2021-02-17
Aomori Olympus Recalls Endoscopic Injectors Due to Seal Defects
Aomori Olympus is recalling specific endoscopic injectors because inspection found inadequate package seals. This defect may allow non-sterile equipment to be used, posing an infection risk.
Product
INJECTOR FORCEMAX UP 2.8MMCH 25G 6MM, model no. NM-400L-0625 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment of esophageal and gastric varices and for submucosal injection in the digestive tract.
Category
Distribution
0 states
HighFDA (Devices)··2021-02-17
Aomori Olympus Recalls NeedleMaster Needles Due to Seal Defects
Aomori Olympus is recalling NeedleMaster needles because some sterile packages have inadequate seals, posing a risk of infection if non-sterile equipment is used.
Product
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.
Category
Distribution
0 states
HighFDA (Devices)··2021-02-17
Aomori Olympus Recalls NeedleMaster Endoscopic Injection Needles Due to Seal Defects
Aomori Olympus is recalling NeedleMaster endoscopic needles because some sterile packages have inadequate seals, posing an infection risk.
Product
NEEDLEMASTER 4MMx 23G UPPER, model no. NM-610L-0423 - Product Usage: Used with endoscopes to perform endoscopic vascular or submucosal injection in the GI tract.
Category
Distribution
0 states
HighFDA (Devices)··2021-02-17
Aomori Olympus Recalls KD-620LR Electrosurgical Snare Due to Seal Defects
Aomori Olympus Co., Ltd. is recalling KD-620LR Electrosurgical Snare units because inspection found some sterile packages have inadequate seals, posing an infection risk.
Product
KD-620LR ELECTROSURGICAL SNARE, model no. KD-620LR - Product Usage: Used with endoscopes and electrosurgical units to cut tissue using high-frequency current within the upper digestive tract.
Category
Distribution
0 states
HighFDA (Devices)··2021-02-17
Aomori Olympus Recalls NeedleMaster Endoscopic Injection Needles Due to Seal Defects
Aomori Olympus is recalling NeedleMaster endoscopic injection needles because some sterile packages have inadequate seals, posing an infection risk.
Product
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.
Category
Distribution
0 states
HighFDA (Devices)··2021-02-17
Aomori Olympus Recalls NeedleMaster Endoscopic Injection Needles Due to Seal Defects
Aomori Olympus is recalling NeedleMaster endoscopic injection needles because some sterile packages have inadequate seals, posing a risk of infection.
Product
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.
Category
Distribution
0 states
HighFDA (Devices)··2021-02-17
Aomori Olympus Endoscopic Injector Recall Due to Package Seal Defects
Aomori Olympus is recalling specific endoscopic injectors because inspection found some sterile packages had inadequate seals, posing a risk of infection if used.
Product
INJECTOR FORCEMAX UP 2MM CH 25G 4MM, model no. NM-401L-0425 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment of esophageal and gastric varices and for submucosal injection in the digestive tract.
Category
Distribution
0 states
HighFDA (Devices)··2021-02-17
Aomori Olympus Recalls ForceMax Lower Injectors Due to Seal Defects
Aomori Olympus is recalling ForceMax Lower injectors because some sterile packages have inadequate seals, posing an infection risk if used.
Product
INJECTOR FORCEMAX LOWER 23G 6MM 5/BX, model no. NM-400U-0623 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment of esophageal and gastric varices and for submucosal injection in the digestive tract.
Category
Distribution
0 states
HighFDA (Devices)··2021-02-17
Aomori Olympus Recalls ForceMax Endoscopic Injectors Due to Seal Defects
Aomori Olympus is recalling ForceMax endoscopic injectors because inspection found some sterile packages have inadequate seals, posing a risk of infection.
Product
INJECTOR FORCEMAX LOWER 23G 5MM, model no. NM-400U-0523 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment of esophageal and gastric varices and for submucosal injection in the digestive tract.
Category
Distribution
0 states
HighFDA (Devices)··2021-02-17
Aomori Olympus Recalls NeedleMaster Endoscopic Injection Needles Due to Seal Defects
Aomori Olympus is recalling NeedleMaster endoscopic needles because some sterile packages have inadequate seals, posing a risk of infection if non-sterile equipment is used.
Product
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.
Category
Distribution
0 states
HighFDA (Devices)··2021-02-17
Aomori Olympus Recalls NeedleMaster Endoscopic Injection Needles Due to Seal Defects
Aomori Olympus is recalling NeedleMaster endoscopic injection needles because some sterile packages have inadequate seals, posing a risk of infection.
Product
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.
Category
Distribution
0 states
HighFDA (Devices)··2021-02-17
Aomori Olympus Recalls Biliary Stents Due to Inadequate Package Seals
Aomori Olympus is recalling biliary stents because inspection found some sterile packages have inadequate seals, posing a risk of infection if non-sterile equipment is used.
Product
PBD-203-0710 BILIARY STENT, model no. PBD-203-0710 -Product Usage: Used with endoscopes for endoscopic retrograde biliary drainage.
Category
Distribution
0 states
HighFDA (Devices)··2021-02-17
Aomori Olympus Recalls NeedleMaster Endoscopic Injection Needles Due to Seal Defects
Aomori Olympus is recalling NeedleMaster endoscopic injection needles because some sterile packages have inadequate seals, posing a risk of infection.
Product
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.
Category
Distribution
0 states
HighFDA (Devices)··2021-02-17
Aomori Olympus Recalls ViziShot Aspiration Needles Due to Seal Defects
Aomori Olympus is recalling ViziShot aspiration needles because some sterile packages have inadequate seals, posing a risk of infection if used.
Product
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.
Category
Distribution
0 states
HighFDA (Devices)··2021-02-17
Aomori Olympus Recalls Guide Sheath Kits Due to Seal Defects
Aomori Olympus is recalling K-202 Guide Sheath Kits because some sterile packages have inadequate seals, posing a risk of infection if non-sterile equipment is used.
Product
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.
Category
Distribution
0 states
HighFDA (Devices)··2021-02-17
Aomori Olympus ForceMax Injector Recalled for Inadequate Package Seals
Aomori Olympus is recalling ForceMax injectors because inspection found some sterile packages have inadequate seals, posing an infection risk.
Product
INJECTOR FORCEMAX UP 2.8MMCH 23G 5MM, model no. NM-400L-0523 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment of esophageal and gastric varices and for submucosal injection in the digestive tract.
Category
Distribution
0 states