The Recall Desk

Manufacturer

Aomori Olympus Co., Ltd.

113 recalls in our database name Aomori Olympus Co., Ltd. as the manufacturing or recalling firm.

What the numbers show

Total
113
Critical
0
Severe
2
Most recent
2023-09-13

Of the 113 recalls from Aomori Olympus Co., Ltd. we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 2 (2%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–25 of 113

  • HighFDA (Devices)·Z-2523-2023·2023-09-13

    Reusable Endoscopy Distal Attachments Recalled for Excessive DEHP Levels

    Aomori Olympus recalls 1,252 reusable distal attachment devices with DEHP chemical levels exceeding safe exposure limits per medical device standards. Devices distributed nationwide in the United States.

    Product
    Reusable distal attachments Models: MH-462, MH-463, MH-464, MH-465, MH-466, MH-483, MH-587, MH-588(US), MH-589, MH-590, MH-591, MH-592, MH-593, MH-594, MH-595, MH-596, MH-597, MH-598, MAJ-289, MAJ-290, MAJ-291, MAJ-292, MAJ-293, MAJ-294, MAJ-295, MAJ-296, MAJ-297, MAJ-663…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2522-2023·2023-09-13

    Olympus Distal Attachment Recalled for Phthalate Exceeding Permissible Levels

    Aomori Olympus Co., Ltd. recalls 1,048 Olympus Distal Attachment units used in EMR kits due to di-2-ethylhexyl phthalate (DEHP) exceeding permissible exposure limits per ISO 10993-17: 2002. Devices were distributed nationwide.

    Product
    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-002, K-003, K-004, K-011, K-012
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0990-2021·2021-02-17

    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
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1010-2021·2021-02-17

    Aomori Olympus ForceMax Injector Recalled for Inadequate Package Seal

    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 2.8MMCH 21G 6MM, model no. NM-400L-0621 - 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
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1026-2021·2021-02-17

    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 UP 2MM CH 23G 3MM, model no. NM-401L-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
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1029-2021·2021-02-17

    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
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1023-2021·2021-02-17

    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
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1014-2021·2021-02-17

    Aomori Olympus Endoscopic Injector Recall Due to Package Seal Defects

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

    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
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0977-2021·2021-02-17

    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
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1013-2021·2021-02-17

    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
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1008-2021·2021-02-17

    Aomori Olympus Recalls ForceMax Injectors Due to Package Seal Defects

    Aomori Olympus is recalling ForceMax injectors because some sterile packages have inadequate 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
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0991-2021·2021-02-17

    Aomori Olympus Recalls SNAREMASTER PLUS Hot/Cold Snare Due to Seal Defects

    Aomori Olympus is recalling SNAREMASTER PLUS Hot/Cold snares because some sterile packages have inadequate seals, posing a risk of infection.

    Product
    SD-400U-10 SNAREMASTER PLUS Hot/Cold 10m, model no. SD-400U-10 - Product Usage: Used with endoscopes for the removal and/or cauterization of diminutive polyps, sessile polyps, pedunculated polyps and tissue from within the GI tract.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0996-2021·2021-02-17

    Aomori Olympus ForceMax Injector Recalled for 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 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
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1068-2021·2021-02-17

    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
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0988-2021·2021-02-17

    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
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1063-2021·2021-02-17

    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
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1025-2021·2021-02-17

    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
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1064-2021·2021-02-17

    Aomori Olympus Recalls Biliary Stents Due to Inadequate Package Seals

    Aomori Olympus is recalling biliary stents because inspection found some sterile packages had inadequate seals, posing a risk of infection if non-sterile equipment is used.

    Product
    PBD-203-0704 BILIARY STENT, model no. PBD-203-0704 -Product Usage: Used with endoscopes for endoscopic retrograde biliary drainage.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1006-2021·2021-02-17

    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
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1009-2021·2021-02-17

    Aomori Olympus ForceMax Injector Recalled for Inadequate Package Seals

    Aomori Olympus is recalling ForceMax UP injectors because inspection found some sterile packages have inadequate seals, posing a risk of infection 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
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1018-2021·2021-02-17

    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
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1012-2021·2021-02-17

    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 if used.

    Product
    INJECTOR FORCEMAX UP 2.8MMCH 23G 6MM, model no. NM-400L-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
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1011-2021·2021-02-17

    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
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1050-2021·2021-02-17

    Aomori Olympus Recalls 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
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1067-2021·2021-02-17

    Aomori Olympus Recalls MAJ-244 Replacement Baskets Due to Seal Defects

    Aomori Olympus is recalling MAJ-244 replacement baskets for the BML-3Q Mechanical Lithotripter because some sterile packages have inadequate seals, posing an infection risk.

    Product
    MAJ-244 SINGLE USE 30MM REPLACEMENT BASKET, model no. MAJ-244 - Product Usage: REPLACEMENT BASKET for BML-3Q Mechanical Lithotripter.
    Category
    Medical Device
    Distribution
    Distributed nationwide