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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Surgical Equipment

Aizu Olympus Co., Ltd.: Various Endoscopes Recalled Due to Risk of Infection from Wet Channels

Agency Publication Date: November 17, 2023
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Summary

Approximately 15,839 various Olympus endoscopes, including bronchoscopes, colonoscopes, and gastroscopes, are being recalled because the process used to dry the device channels after repair was not properly validated. This flaw resulted in a small percentage of devices being returned to healthcare facilities with moisture still inside the internal channels. The presence of water inside these medical instruments can lead to bacterial growth and contamination. No specific injuries or infections have been reported to date; however, the manufacturer has initiated this voluntary recall to ensure the safety of medical procedures and has issued a notification letter to affected customers.

Risk

Water remaining inside the internal channels of the endoscopes creates an environment where bacteria can grow, potentially leading to the transmission of infections between patients during medical procedures.

What You Should Do

  1. Identify if your facility possesses any of the affected Olympus models, which include Bronchoscopes (BF series), Colonoscopes (CF/PCF series), Gastroscopes (GF/GIF series), and others including Cystonephroscopes, Rhinolaryngoscopes, and Ureteralscopes.
  2. Check the specific model numbers and UDI-DI identifiers against the provided list, such as Bronchoscope BF-1T150 (04953170308185), Colonoscope CF-H190I (04953170305177), and Gastrointestinal videoscope GIF-HQ190 (04953170305276).
  3. If you have an affected device, follow the instructions provided in the manufacturer's notification letter sent on September 25, 2023, regarding the handling and inspection of returned repaired scopes.
  4. Contact your healthcare provider or Olympus directly to discuss any concerns regarding the sterilization and drying status of your specific equipment.
  5. For further technical guidance or to report issues, contact Olympus at the phone number provided in your notification or reach out to the FDA directly at 1-888-463-6332 (1-888-INFO-FDA).

Your Remedy Options

๐Ÿ“‹Other Action

Risk mitigation through firm notification

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: Bronchoscope
Model / REF:
BF-1T150
BF-1T60
BF-1TH190
BF-1TQ170
BF-3C160
BF-3C40
BF-H190
BF-MP190F
BF-MP60
BF-P150
BF-P190
BF-P60
BF-Q170
BF-Q190
BF-XP190
BF-XP60
BF-XT160
BF-XT190
UPC Codes:
04953170308185
04953170308161
04953170335181
04953170342943
04953170340031
04953170308130
04953170335174
04953170395581
04953170308277
04953170308178
04953170342110
04953170308123
04953170342912
04953170335198
04953170342134
04953170308154
04953170340147
04953170402470
Product: Bronchoscope - Ultrasonic
Model / REF:
BF-UC180F
BF-UC190F
UPC Codes:
04953170356360
04953170399831
Product: Colonoscope
Model / REF:
CF-2T160I
CF-2T160L
CF-H170I
CF-H170L
CF-H180AI
CF-H180AL
CF-H180DI
CF-H180DL
CF-H190I
CF-H190L
CF-HQ190I
CF-HQ190L
CF-LV1I
CF-LV1L
CF-Q150I
CF-Q150L
CF-Q160S
CF-Q180AI
CF-Q180AL
UPC Codes:
04953170307645
04953170307652
04953170334184
04953170334160
04953170339585
04953170339608
04953170339639
04953170339653
04953170305177
04953170305153
04953170305139
04953170305115
04953170312410
04953170312397
04953170307621
04953170307638
04953170307669
04953170307690
04953170307706
Product: Choleodochoscope
Model / REF:
CHF-BP30
CHF-CB30L
CHF-P60
UPC Codes:
04953170068751
04953170340154
Product: Cystonephroscope
Model / REF:
CYF-5
CYF-VH
CYF-VHR
UPC Codes:
04953170292323
04953170411250
04953170411298
Product: Rhinolaryngoscope
Model / REF:
ENF-T3
ENF-VT2
ENF-VT3
UPC Codes:
04953170307188
04953170339509
04953170411526
Product: Gastroscope
Model / REF:
GF-UC140P-AL5
GF-UCT180
GF-UE160-AL5
UPC Codes:
04953170356322
04953170356339
04953170356261
Product: Gastrointestinal videoscope
Model / REF:
GIF-1TH190
GIF-1TQ160
GIF-2T160
GIF-2TH180
GIF-H170
GIF-H180
GIF-H180J
GIF-H190
GIF-HQ190
GIF-LV1
GIF-N180
GIF-Q150
GIF-Q160Z
GIF-Q180
GIF-XP180N
GIF-XP190N
GIF-XTQ160
UPC Codes:
04953170343360
04953170307492
04953170339745
04953170334115
04953170339769
04953170307539
04953170305290
04953170305276
04953170312373
04953170307508
04953170307485
04953170066795
04953170307522
04953170307515
04953170305313
04953170339837
Product: Uretero-reno fiberscope
Model / REF:
URF-P7
URF-P7R
URF-V2
URF-V2R
URF-V3
URF-V3R
UPC Codes:
04953170403811
04953170403835
04953170343582
04953170343612
04953170403385
04953170403392

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 93222
Status: Active
Manufacturer: Aizu Olympus Co., Ltd.
Sold By: Authorized Medical Distributors; Direct Hospital Sales
Manufactured In: Japan
Units Affected: 21 products (1123 units; 823 units; 3344 units; 3 units; 1243 units; 46 units; 680 units; 3627 units; 0 units; 27 units; 16 units; 65 units; 61 units; 33 units; 3101 units; 8 units; 32 units; 25 units; 5 units; 0 units; 1577 units)
Distributed To: Nationwide
Agency Last Updated: July 3, 2025

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.