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.

101–111 of 111

HighFDA (Devices)··2021-02-17
Aomori Olympus Recalls KD-650L Electrosurgical Snare Due to Seal Defects
Aomori Olympus Co., Ltd. is recalling KD-650L Electrosurgical Snare units because some sterile packages have inadequate seals, posing an infection risk.
Product
KD-650L ELECTROSURGICAL SNARE, model no. KD-650L - 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 a risk of infection if non-sterile equipment is used.
Product
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.
Category
Distribution
0 states
HighFDA (Devices)··2021-02-17
Aomori Olympus Recalls Aspiration Needles Due to Inadequate Package Seals
Aomori Olympus is recalling NA-601D-1519 aspiration needles because some sterile packages have inadequate seals, posing a risk of infection.
Product
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.
Category
Distribution
0 states
HighFDA (Devices)··2021-02-17
Aomori Olympus Electrosurgical Snare Recalled for Inadequate Package Seals
Aomori Olympus is recalling SD-240U-10 electrosurgical snares because inspection found inadequate package seals. Non-sterile equipment use may lead to patient infection.
Product
SD-240U-10 ELECTROSURGICAL SNARE, model no. SD-240U-10 - Product Usage: Used with endoscopes to electrosurgically resect tissue within the digestive tract.
Category
Distribution
0 states
HighFDA (Devices)··2021-02-17
Aomori Olympus ForceMax Injector Recall Due to Inadequate Package Seals
Aomori Olympus is recalling ForceMax Up injectors because some sterile packages have inadequate seals, posing a risk of infection if non-sterile equipment is used.
Product
INJECTOR FORCEMAX UP 2MM CH 25G 6MM, model no. NM-401L-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 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 4MMx 25G UPPER, model no. NM-610L-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 injection needles because some sterile packages have inadequate seals, posing a risk of infection.
Product
NEEDLEMASTER 4MMx 21G UPPER, model no. NM-610L-0421 - 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 25G LOWER, model no. NM-610U-0625 - 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 Aspiration Needles Due to Inadequate Package Seals
Aomori Olympus is recalling NA-411D-1521 aspiration needles because some sterile packages have inadequate seals, posing a risk of infection if non-sterile equipment is used.
Product
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.
Category
Distribution
0 states
HighFDA (Devices)··2021-02-17
Aomori Olympus NeedleMaster Endoscopic Injection Needles Recalled for Seal Defects
Aomori Olympus is recalling NeedleMaster endoscopic injection needles because inspection found inadequate package seals, posing a risk of infection if non-sterile equipment is used.
Product
NEEDLEMASTER 4MMx 26G UPPER, model no. NM-610L-0426 - 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 Aspiration Needles Due to Inadequate Package Seals
Aomori Olympus is recalling Vizishot 21G aspiration needles because some sterile packages have inadequate seals, posing a risk of infection if non-sterile equipment is used.
Product
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.
Category
Distribution
0 states