Aizu Olympus Co., Ltd. recall records

30 reported ongoing

31 records in this archive. Latest source date Oct 31, 2025.

FDA enforcement status can lag behind the recall lifecycle. An empty search or a reported termination is not a personal product-safety determination.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.

Records and reported status

FDA device enforcement

Olympus OER-Elite

Inform existing affected device customers about pertinent Warnings/Cautions, existing recommended maintenance schedules and that only properly trained personnel conduct repairs and maintenance.

Class IIReported ongoing

Distribution: US Nationwide distribution.

Official source for Olympus OER-Elite
FDA device enforcement

Olympus OER-Pro

Inform existing affected device customers about pertinent Warnings/Cautions, existing recommended maintenance schedules and that only properly trained personnel conduct repairs and maintenance.

Class IIReported ongoing

Distribution: US Nationwide distribution.

Official source for Olympus OER-Pro
FDA device enforcement

Olympus OER-Mini

Inform existing affected device customers about pertinent Warnings/Cautions, existing recommended maintenance schedules and that only properly trained personnel conduct repairs and maintenance.

Class IIReported ongoing

Distribution: US Nationwide distribution.

Official source for Olympus OER-Mini
FDA device enforcement

GIF-H190, EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE

Specific devices may have an improperly repaired light guide connector due to missing adhesive to secure the suction channel mouthpiece to the scope connector. Issue may result in loss of image, decreased suction, or impact the ability to effectively reproc...

Class IIReported ongoing

Distribution: Domestic distribution to FL, KY, MA, NJ, NY, and PA

Official source for GIF-H190, EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE
FDA device enforcement

GIF-HQ190, EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE

Specific devices may have an improperly repaired light guide connector due to missing adhesive to secure the suction channel mouthpiece to the scope connector. Issue may result in loss of image, decreased suction, or impact the ability to effectively reproc...

Class IIReported ongoing

Distribution: Domestic distribution to FL, KY, MA, NJ, NY, and PA

Official source for GIF-HQ190, EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE
FDA device enforcement

Bronchoscope-for endoscopy and endoscopic surgery within the airways and tracheobronchial tree. Model Numbers: BF-1T150, BF-1T60, BF-1TH190, BF-1TQ170, BF-3C160, BF-3C40, BF-H19...

Channel air drying process was not validated, and that a small percentage of scopes returned to customers after repair had a wet channel. Water remaining in the channel of the endoscopes has the potential for contamination that could lead to the risk of inf...

Class IIReported ongoing

Distribution: Worldwide - US Nationwide distribution.

Official source for Bronchoscope-for endoscopy and endoscopic surgery within the airways and tracheobronchial tree. M...
FDA device enforcement

Bronchoscope - Ultrasonic: endoscopic real-time ultrasonic imaging, ultrasound guided needle aspiration and other endoscopic procedures within the airways, trancheobronchial tre...

Channel air drying process was not validated, and that a small percentage of scopes returned to customers after repair had a wet channel. Water remaining in the channel of the endoscopes has the potential for contamination that could lead to the risk of inf...

Class IIReported ongoing

Distribution: Worldwide - US Nationwide distribution.

Official source for Bronchoscope - Ultrasonic: endoscopic real-time ultrasonic imaging, ultrasound guided needle aspi...
FDA device enforcement

Colonoscope: for endoscopy and endoscopic surgery within the lower digestive tract (including the anus, rectum, sigmoid colon, colon and ileocecal valve). Model Numbers: CF-2T16...

Channel air drying process was not validated, and that a small percentage of scopes returned to customers after repair had a wet channel. Water remaining in the channel of the endoscopes has the potential for contamination that could lead to the risk of inf...

Class IIReported ongoing

Distribution: Worldwide - US Nationwide distribution.

Official source for Colonoscope: for endoscopy and endoscopic surgery within the lower digestive tract (including the...
FDA device enforcement

Choleodochoscope. Model Numbers: CHF-BP30, CHF-CB30L, CHF-P60.

Channel air drying process was not validated, and that a small percentage of scopes returned to customers after repair had a wet channel. Water remaining in the channel of the endoscopes has the potential for contamination that could lead to the risk of inf...

Class IIIReported ongoing

Distribution: Worldwide - US Nationwide distribution.

Official source for Choleodochoscope. Model Numbers: CHF-BP30, CHF-CB30L, CHF-P60.
FDA device enforcement

Cystonephroscope-endoscopic diagnosis and treatment within the bladder, urethra, and kidney Model Numbers: CYF-5, CYF-VH, CYF-VHR.

Channel air drying process was not validated, and that a small percentage of scopes returned to customers after repair had a wet channel. Water remaining in the channel of the endoscopes has the potential for contamination that could lead to the risk of inf...

Class IIReported ongoing

Distribution: Worldwide - US Nationwide distribution.

Official source for Cystonephroscope-endoscopic diagnosis and treatment within the bladder, urethra, and kidney Model...
FDA device enforcement

Rhinolaryngoscope-for endoscopic diagnosis and treatment within the nasal lumens and airway anatomy (including nasopharyngeal and trachea). Model Numbers: ENF-T3, ENF-VT2, ENF-VT3.

Channel air drying process was not validated, and that a small percentage of scopes returned to customers after repair had a wet channel. Water remaining in the channel of the endoscopes has the potential for contamination that could lead to the risk of inf...

Class IIReported ongoing

Distribution: Worldwide - US Nationwide distribution.

Official source for Rhinolaryngoscope-for endoscopic diagnosis and treatment within the nasal lumens and airway anato...
FDA device enforcement

Gastroscope-endoscopic ultrasound (EUS) guided fine needle aspiration (FNA) and for endoscopic surgery within the upper digestive tract. Model Numbers: GF-UC140P-AL5, GF-UCT180,...

Channel air drying process was not validated, and that a small percentage of scopes returned to customers after repair had a wet channel. Water remaining in the channel of the endoscopes has the potential for contamination that could lead to the risk of inf...

Class IIReported ongoing

Distribution: Worldwide - US Nationwide distribution.

Official source for Gastroscope-endoscopic ultrasound (EUS) guided fine needle aspiration (FNA) and for endoscopic su...
FDA device enforcement

Gastrointestinal videoscope-indicated for use within the upper digestive tract (including the esophagus, stomach, and duodenum). Model Numbers: GIF-1TH190, GIF-1TQ160, GIF-2T160...

Channel air drying process was not validated, and that a small percentage of scopes returned to customers after repair had a wet channel. Water remaining in the channel of the endoscopes has the potential for contamination that could lead to the risk of inf...

Class IIReported ongoing

Distribution: Worldwide - US Nationwide distribution.

Official source for Gastrointestinal videoscope-indicated for use within the upper digestive tract (including the eso...
FDA device enforcement

Hysteroscope-For endoscopic diagnosis within the uterus Model Number: HYF-1T.

Channel air drying process was not validated, and that a small percentage of scopes returned to customers after repair had a wet channel. Water remaining in the channel of the endoscopes has the potential for contamination that could lead to the risk of inf...

Class IIReported ongoing

Distribution: Worldwide - US Nationwide distribution.

Official source for Hysteroscope-For endoscopic diagnosis within the uterus Model Number: HYF-1T.
FDA device enforcement

Hysterovideoscope-For endoscopic diagnosis within the uterus Model Number: HYF-V.

Channel air drying process was not validated, and that a small percentage of scopes returned to customers after repair had a wet channel. Water remaining in the channel of the endoscopes has the potential for contamination that could lead to the risk of inf...

Class IIReported ongoing

Distribution: Worldwide - US Nationwide distribution.

Official source for Hysterovideoscope-For endoscopic diagnosis within the uterus Model Number: HYF-V.
FDA device enforcement

Hysterofiberscope-For endoscopic diagnosis within the uterus. Model Number: HYF-XP.

Channel air drying process was not validated, and that a small percentage of scopes returned to customers after repair had a wet channel. Water remaining in the channel of the endoscopes has the potential for contamination that could lead to the risk of inf...

Class IIReported ongoing

Distribution: Worldwide - US Nationwide distribution.

Official source for Hysterofiberscope-For endoscopic diagnosis within the uterus. Model Number: HYF-XP.
FDA device enforcement

Tracheal fiberscope-airway management, which includes observation to access airway anatomy, endotracheal/endobronchial intubation and management. Model Numbers: LF-DP, LF-GP, LF...

Channel air drying process was not validated, and that a small percentage of scopes returned to customers after repair had a wet channel. Water remaining in the channel of the endoscopes has the potential for contamination that could lead to the risk of inf...

Class IIReported ongoing

Distribution: Worldwide - US Nationwide distribution.

Official source for Tracheal fiberscope-airway management, which includes observation to access airway anatomy, endot...

Reasons in these listed records

  • Inform existing affected device customers about pertinent Warnings/Cautions, existing recommended maintenance schedules and that only properly trained personnel conduct repairs and maintenance.
  • Specific devices may have an improperly repaired light guide connector due to missing adhesive to secure the suction channel mouthpiece to the scope connector. Issue may result in loss of image, decreased suction, or impact the ability to effectively reprocess the device. This...
  • Channel air drying process was not validated, and that a small percentage of scopes returned to customers after repair had a wet channel. Water remaining in the channel of the endoscopes has the potential for contamination that could lead to the risk of infection

These examples come from this result page and are not a ranking of every recall reason.

Checking Aizu Olympus Co., Ltd.

Is there a recall on aizu olympus co., ltd. right now?

This archive contains 31 records, including 30 with agency-reported ongoing status. The status field can be incomplete or stale. Open the current official notice and match your exact product.

How do I check my package or product?

Compare the product, firm and lot, date, model or serial identifiers with the notice. Use the label-check guide if you need help locating an identifier.

Does a matching name mean every item is included?

A name is a search match. The agency notice sets the affected products and identifiers. Do not assume that every item with the same name or brand belongs to the recall.

What if the search finds no matching record?

This search has source and keyword limits. Missing records or a missing lot code do not establish that a product is unaffected. Check source coverage and the agency's current notices.

Where can I find older records?

Use monthly archives or the local search. The initial import covers records dated from October 2021 where available; each source's actual first and latest dates appear on the coverage page.

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