The Recall Desk

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.

51–75 of 111

  • HighFDA (Devices)··2021-02-17

    Aomori Olympus Recalls Electrosurgical Snare Due to Inadequate Package Seals

    Aomori Olympus is recalling KD-655U electrosurgical snares because some sterile packages have inadequate seals, posing a risk of infection if non-sterile equipment is used.

    Product
    KD-655U ELECTROSURGICAL SNARE, model no. KD-655U - 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 6mm x 23G Upper needles because some sterile packages have inadequate seals, posing an infection risk.

    Product
    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.
    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 some sterile packages have inadequate seals, posing an infection risk if non-sterile equipment is used.

    Product
    INJECTOR FORCEMAX UP 2.8MMCH 25G 4MM, model no. NM-400L-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 Guide Sheath Kits Due to Seal Defects

    Aomori Olympus is recalling K-202 Guide Sheath Kits because some sterile packages have inadequate seals, posing an infection risk.

    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 Recalls ForceMax Endoscopic Injectors Due to Seal Defects

    Aomori Olympus is recalling ForceMax endoscopic injectors because some sterile packages have inadequate seals, which could lead to patient infection.

    Product
    INJECTOR FORCEMAX LOWER 23G 3MM, model no. NM-400U-0323 - 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 Injectors Due to Seal Defects

    Aomori Olympus is recalling ForceMax injectors because some sterile packages have inadequate seals, posing a risk of infection if non-sterile equipment is used.

    Product
    INJECTOR FORCEMAX 25G 2.5MM, model no. NM-400U-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 Endoscopic Injector Recall Due to Inadequate Package Seals

    Aomori Olympus is recalling INJECTOR FORCEMAX LOWER 23G 4MM devices because inspection found some sterile packages have inadequate seals, posing an infection risk.

    Product
    INJECTOR FORCEMAX LOWER 23G 4MM, model no. NM-400U-0423 - 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 UP Injectors Due to Seal Defects

    Aomori Olympus is recalling ForceMax UP injectors because some sterile packages have inadequate seals, posing an infection risk.

    Product
    INJECTOR FORCEMAX UP 2.8MMCH 25G 5MM, model no. NM-400L-0525 - 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 ForceMax Injector Recall Due to Package Seal Defects

    Aomori Olympus is recalling ForceMax injectors because some sterile packages have inadequate seals, posing a risk of infection if non-sterile equipment is used.

    Product
    INJECTOR FORCEMAX UP 2.8MMCH 23G 4MM, model no. NM-400L-0423 - 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 Endoscopic Injectors Due to Inadequate Package Seals

    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 LOWER 25G 5MM, model no. NM-400U-0525 - 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 used.

    Product
    NEEDLEMASTER 3MMx 23G LOWER, model no. NM-610L-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 K-203 Guide Sheath Kits Due to Seal Defects

    Aomori Olympus is recalling K-203 Guide Sheath Kits because some sterile packages have inadequate seals, which could allow non-sterile equipment to be used and lead to patient infection.

    Product
    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.
    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 some sterile packages have inadequate seals, posing a risk of infection.

    Product
    INJECTOR FORCEMAX LOWER 23G 6MM, 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 some sterile packages have inadequate seals, posing an infection risk.

    Product
    INJECTOR FORCEMAX LOWER 23G 3MM, model no. NM-400U-0323 - 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 ForceMax Injector Recalled for Inadequate Package Seals

    Aomori Olympus is recalling ForceMax injectors because some sterile packages have partial heat seals, which could allow non-sterile equipment to be used and cause infection.

    Product
    INJECTOR FORCEMAX SIF 270CM 23G 4MM, model no. NM-400Y-0423 - 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 MAJ-247 Replacement Baskets Due to Seal Defects

    Aomori Olympus is recalling MAJ-247 replacement baskets for the BML-3Q Mechanical Lithotripter because some sterile packages have inadequate seals, posing an infection risk.

    Product
    MAJ-247 SINGLE USE 30MM REPLACEMENT BASKET, model no. MAJ-247 - Product Usage: REPLACEMENT BASKET for BML-3Q Mechanical Lithotripter.
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2021-02-17

    Aomori Olympus Recalls Guide Sheath Kits Due to Seal Defects

    Aomori Olympus is recalling K-203 Guide Sheath Kits because some sterile packages have inadequate seals, posing a risk of infection if non-sterile equipment is used.

    Product
    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.
    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 inspection found some sterile packages had inadequate seals, posing a risk of infection if non-sterile equipment is used.

    Product
    PBD-203-0703 BILIARY STENT, model no. PBD-203-0703 - 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 an infection risk.

    Product
    NEEDLEMASTER 5MMx 25G UPPER, model no. NM-610L-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 K-201 Guide Sheath Kits Due to Seal Defects

    Aomori Olympus is recalling K-201 Guide Sheath Kits because some sterile packages have inadequate seals, posing an infection risk if used.

    Product
    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.
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2021-02-17

    Aomori Olympus Recalls B5-2C Balloon Catheters Due to Seal Defects

    Aomori Olympus is recalling B5-2C balloon catheters because some sterile packages have inadequate seals, posing a risk of infection if used.

    Product
    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 bile duct, pancreatic duct, and respiratory organs.
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2021-02-17

    Aomori Olympus Recalls Aspiration Needles Due to Seal Defects

    Aomori Olympus is recalling NA-401D-1521 aspiration needles because some sterile packages have inadequate seals, posing a risk of infection.

    Product
    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.
    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 some sterile packages have partial heat seals, creating a risk of infection if non-sterile equipment is used.

    Product
    INJECTOR FORCEMAX UP 2.8MMCH 25G 4MM, model no. NM-400L-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
  • SevereFDA (Devices)··2021-02-17

    Aomori Olympus Electrosurgical Snare Recalled for Inadequate Package Seals

    Aomori Olympus is recalling SD-240U-25 electrosurgical snares because inspection found some sterile packages have inadequate seals, posing an infection risk.

    Product
    SD-240U-25 ELECTROSURGICAL SNARE, model no. SD-240U-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 Recalls Guide Sheath Kits Due to Seal Defects

    Aomori Olympus is recalling K-204 Guide Sheath Kits because some sterile packages have inadequate seals, posing a risk of infection if used.

    Product
    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.
    Category
    Distribution
    0 states