The Recall Desk

Manufacturer

Olympus Corporation of the Americas

415 recalls in our database name Olympus Corporation of the Americas as the manufacturing or recalling firm.

What the numbers show

Total
415
Critical
27
Severe
40
Most recent
2026-09-02

Of the 415 recalls from Olympus Corporation of the Americas we have scored against our rubric, 27 (7%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 40 (10%) 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.

101–125 of 415

  • ModerateFDA (Devices)·Z-1282-2026·2026-02-11

    Sphincterotome KD-VC412Q-0215 recalled over a skipped thermoforming step

    Olympus is recalling the Single Use 3-Lumen Sphincterotome V (Distal Wire guided), model KD-VC412Q-0215, because devices which did not undergo thermoforming could deform and lose performance.

    Product
    Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC412Q-0215; Software Version: N/A Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1284-2026·2026-02-11

    Sphincterotome KD-VC433Q-0730 recalled over a skipped thermoforming step

    Olympus is recalling the Single Use 3-Lumen Sphincterotome V (Distal Wire guided), model KD-VC433Q-0730, because devices which did not undergo thermoforming could deform and lose performance.

    Product
    Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number:KD-VC433Q-0730; Software Version: N/A Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency c
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1275-2026·2026-02-11

    Sphincterotome KD-V431M-0720 recalled over a skipped thermoforming step

    Olympus is recalling the Single Use 3-Lumen Sphincterotome V, model KD-V431M-0720, because devices which did not undergo thermoforming could deform and lose performance.

    Product
    Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V431M-0720; Software Version: N/A Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1278-2026·2026-02-11

    Distal wire guided sphincterotomes recalled over a skipped thermoforming step

    Olympus is recalling the Single Use 3-Lumen Sphincterotome V (Distal Wire guided), model KD-VC411Q-0720, because devices which did not undergo thermoforming could deform and lose performance.

    Product
    Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC411Q-0720; Software Version: N/A Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1297-2026·2026-02-11

    Sphincterotome KD-VC411Q-0725 recalled over a skipped thermoforming step

    Olympus is recalling the Single Use 3-Lumen Sphincterotome V (Distal Wire guided), model KD-VC411Q-0725, because devices which did not undergo thermoforming could deform and lose performance.

    Product
    Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC411Q-0725; Software Version: N/A Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1296-2026·2026-02-11

    Sphincterotome KD-V411M-3025 recalled over a skipped thermoforming step

    Olympus is recalling the Single Use 3-Lumen Sphincterotome V, model KD-V411M-3025, because devices which did not undergo thermoforming could deform and lose performance.

    Product
    Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-3025 Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1276-2026·2026-02-11

    Sphincterotome KD-V431M-0730 recalled over a skipped thermoforming step

    Olympus is recalling the Single Use 3-Lumen Sphincterotome V, model KD-V431M-0730, because devices which did not undergo thermoforming could deform and lose performance.

    Product
    Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V431M-0730; Software Version: N/A Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1286-2026·2026-02-11

    Sphincterotome KD-411Q-0730 recalled over a skipped thermoforming step

    Olympus is recalling the Disposable Triple Lumen Sphincterotome, model KD-411Q-0730, because devices which did not undergo thermoforming could deform and lose performance.

    Product
    Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-411Q-0730 Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1290-2026·2026-02-11

    Sphincterotomes recalled over devices that skipped a thermoforming step

    Olympus is recalling 3,954 Single Use 3-Lumen Sphincterotome V units because devices which did not undergo thermoforming could deform and lose performance.

    Product
    Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-1520 Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1289-2026·2026-02-11

    Sphincterotome KD-401Q-0730 recalled over a skipped thermoforming step

    Olympus is recalling the Disposable Triple Lumen Sphincterotome, model KD-401Q-0730, because devices which did not undergo thermoforming could deform and lose performance.

    Product
    Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0730 Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1274-2026·2026-02-11

    Sphincterotome KD-V411M-0730 recalled over a skipped thermoforming step

    Olympus is recalling the Single Use 3-Lumen Sphincterotome V, model KD-V411M-0730, because devices which did not undergo thermoforming could deform and lose performance.

    Product
    Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-0730; Software Version: N/A Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-0570-2026·2025-12-03

    Ligating devices recalled because the loop may not release as expected

    Olympus is recalling 7,803 Single Use Ligating Devices because the ligation loop may fail to release or detach, leaving it unintentionally fixed around patient anatomy.

    Product
    Brand Name: Single Use Ligating Device Product Name: Olympus HX-400U-30 Model/Catalog Number: HX-400U-30 Used with an Olympus endoscope to deliver a nylon loop snare.
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0579-2026·2025-12-03

    Duodenoscopes recalled after continued reports of positive cultures and infections

    Olympus is recalling 7,023 EVIS EXERA III TJF-Q190V duodenovideoscopes after continued reports of positive cultures and infections, and is updating the reprocessing materials.

    Product
    Brand Name: EVIS EXERA III Duodenovideoscope Product Name: Olympus TJF-Q190V Model/Catalog Number: TJF-Q190V Product Description: This instrument is intended to be used with an Olympus video system center, light source, documentation equipment, monitor, EndoTherapy accessorie
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0572-2026·2025-11-26

    Nephrostomy balloon kits recalled after containing the wrong sized catheter

    Olympus is recalling 60 Nephro-EZDilate nephrostomy balloon catheter kits because they contained a 4mm x 4cm urinary tract balloon instead of the correct 8mm x 15cm nephrostomy balloon.

    Product
    Brand Name: EZDilate Nephrostomy Balloon Catheter and Inflation Device Kit Product Name: Olympus Nephro-EZDilate Nephrostomy Balloon Catheter Model/Catalog Number: BPCN0815K Product Description: The Nephro-EZDilate nephrostomy balloon catheter is a reinforced catheter attached
    Category
    Medical Device
    Distribution
    6 states
  • HighFDA (Devices)·Z-0483-2026·2025-11-19

    Fifteen millimetre snares recalled over holes compromising package sterility

    Olympus is recalling 18,174 Single Use Electrosurgical Snares SD-400U-15 because sterility may be compromised by small holes formed during packaging or transportation.

    Product
    Brand Name: Olympus Single Use Single Use Electrosurgical Snare SD-400 Product Name: Single Use Single Use Electrosurgical Snare Model/Catalog Number: SD-U400U-15 Product Description: These instruments have been designed to be used with an Olympus endoscope for the removal and
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0452-2026·2025-11-19

    Lithotripsy transducers recalled over startup failures and handpiece temperature rise

    Olympus is recalling 1,528 ShockPulse Lithotripsy Transducers because the device may fail to start or stop shortly after starting, and the handpiece body may heat up during clinical use.

    Product
    Brand Name: Lithotriptor, Ultrasonic Product Name: ShockPulse Lithotripsy Transducer Model/Catalog Number: SPL-T Product Description: The ShockPulse Lithotripsy System is an electromechanical device capable of fragmenting calculi and aspirating stone debris. The ShockPulse tra
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0482-2026·2025-11-19

    Electrosurgical snares recalled over small holes compromising package sterility

    Olympus is recalling 48,208 Single Use Electrosurgical Snares SD-400 because sterility may be compromised by small holes formed during packaging or transportation.

    Product
    Brand Name: Olympus Single Use Electrosurgical Snare SD-400 Product Name: Single Use Electrosurgical Snare Model/Catalog Number: SD-400U-10 Product Description: These instruments have been designed to be used with an Olympus endoscope for the removal and/or cauterization of di
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-0063-2026·2025-10-22

    BF-Q190 bronchovideoscopes recalled for clarified laser and coagulation instructions

    Olympus is recalling EVIS EXERA III Bronchovideoscope BF-Q190 units for instructions-for-use updates on safe use with laser, argon plasma coagulation and high-frequency therapy equipment.

    Product
    EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-Q190
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-0050-2026·2025-10-22

    BF-1TQ170 bronchovideoscopes recalled for updated instructions on laser use

    Olympus is recalling Bronchovideoscope BF-1TQ170 units for instructions-for-use updates on safe use with laser, argon plasma coagulation and high-frequency therapy equipment.

    Product
    BRONCHOVIDEOSCOPE OLYMPUS BF-1TQ170
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-0062-2026·2025-10-22

    BF-Q180-AC bronchovideoscopes recalled for updated laser and coagulation use instructions

    Olympus is recalling EVIS EXERA II Bronchovideoscope BF Type Q180-AC units for instructions-for-use updates on safe use with laser, argon plasma coagulation and high-frequency therapy equipment.

    Product
    EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE Q180-AC
    Category
    Medical Device
    Distribution
    Distributed nationwide