Aizu Olympus Co., Ltd.: 31 FDA recall reports
Every medical device recall the FDA has published for Aizu Olympus Co., Ltd.. The fault, and how the agency graded it.
31Reports
0Class I
30Ongoing
2025-12-10Most recent
What the classes mean
The FDA sorts every recall into one of three classes. The class is the whole story. It is also the part people skip.
Class II is the bulk of every list here. That matters. A long list of Class II says something different from one Class I.
By class
By year reported
Checking whether it affects you
The lot or code number is what matters. Not the product name. A recall covers
specific lots. Yours may not be one of them.
Check the code on your package against the report. The FDA keeps the current
list at fda.gov/safety/recalls.
The reports
The text below is quoted from the FDA record word for word.
Olympus OER-Elite
Z-0872-2026 · Class II · reported 2025-12-10 · Ongoing
- Why it was recalled
- Inform existing affected device customers about pertinent Warnings/Cautions, existing recommended maintenance schedules and that only properly trained personnel conduct repairs and maintenance.
- Product
- Olympus OER-Elite
- Where it went
- US Nationwide distribution.
- How much
- 6578 units
Olympus OER-Pro
Z-0873-2026 · Class II · reported 2025-12-10 · Ongoing
- Why it was recalled
- Inform existing affected device customers about pertinent Warnings/Cautions, existing recommended maintenance schedules and that only properly trained personnel conduct repairs and maintenance.
- Product
- Olympus OER-Pro
- Where it went
- US Nationwide distribution.
- How much
- 6578 units
Olympus OER-Mini
Z-0874-2026 · Class II · reported 2025-12-10 · Ongoing
- Why it was recalled
- Inform existing affected device customers about pertinent Warnings/Cautions, existing recommended maintenance schedules and that only properly trained personnel conduct repairs and maintenance.
- Product
- Olympus OER-Mini
- Where it went
- US Nationwide distribution.
- How much
- 6578 units
PCF-H190L, EVIS EXERA III COLONOVIDEOSCOPE
Z-0419-2024 · Class II · reported 2023-12-06 · Ongoing
- Why it was recalled
- 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 in turn may lead to unanticipated delay to treatment, or patient exposure to contaminated material and subsequent infection.
- Product
- PCF-H190L, EVIS EXERA III COLONOVIDEOSCOPE
- Where it went
- Domestic distribution to FL, KY, MA, NJ, NY, and PA
- How much
- 24 incorrectly repaired units
PCF-H190DL, EVIS EXERA III COLONOVIDEOSCOPE
Z-0418-2024 · Class II · reported 2023-12-06 · Ongoing
- Why it was recalled
- 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 in turn may lead to unanticipated delay to treatment, or patient exposure to contaminated material and subsequent infection.
- Product
- PCF-H190DL, EVIS EXERA III COLONOVIDEOSCOPE
- Where it went
- Domestic distribution to FL, KY, MA, NJ, NY, and PA
- How much
- 24 incorrectly repaired units
CF-HQ190L EVIS EXERA III COLONOVIDEOSCOPE
Z-0415-2024 · Class II · reported 2023-12-06 · Ongoing
- Why it was recalled
- 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 in turn may lead to unanticipated delay to treatment, or patient exposure to contaminated material and subsequent infection.
- Product
- CF-HQ190L EVIS EXERA III COLONOVIDEOSCOPE
- Where it went
- Domestic distribution to FL, KY, MA, NJ, NY, and PA
- How much
- 24 incorrectly repaired units
GIF-H190, EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE
Z-0416-2024 · Class II · reported 2023-12-06 · Ongoing
- Why it was recalled
- 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 in turn may lead to unanticipated delay to treatment, or patient exposure to contaminated material and subsequent infection.
- Product
- GIF-H190, EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE
- Where it went
- Domestic distribution to FL, KY, MA, NJ, NY, and PA
- How much
- 24 incorrectly repaired units
GIF-HQ190, EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE
Z-0417-2024 · Class II · reported 2023-12-06 · Ongoing
- Why it was recalled
- 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 in turn may lead to unanticipated delay to treatment, or patient exposure to contaminated material and subsequent infection.
- Product
- GIF-HQ190, EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE
- Where it went
- Domestic distribution to FL, KY, MA, NJ, NY, and PA
- How much
- 24 incorrectly repaired units
Signmoidovideoscope-For endoscopy and endoscopic surgery within the lower digestive tract (including the anus,
Z-0342-2024 · Class II · reported 2023-11-29 · Ongoing
- Why it was recalled
- 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
- Product
- Signmoidovideoscope-For endoscopy and endoscopic surgery within the lower digestive tract (including the anus, rectum and sigmoid colon). Model Number: PCF-S.
- Where it went
- Worldwide - US Nationwide distribution.
- How much
- 8 units
Tracheal fiberscope-airway management, which includes observation to access airway anatomy, endotracheal/endob
Z-0338-2024 · Class II · reported 2023-11-29 · Ongoing
- Why it was recalled
- 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
- Product
- Tracheal fiberscope-airway management, which includes observation to access airway anatomy, endotracheal/endobronchial intubation and management. Model Numbers: LF-DP, LF-GP, LF-TP.
- Where it went
- Worldwide - US Nationwide distribution.
- How much
- 65 units
Gastroscope-endoscopic ultrasound (EUS) guided fine needle aspiration (FNA) and for endoscopic surgery within
Z-0333-2024 · Class II · reported 2023-11-29 · Ongoing
- Why it was recalled
- 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
- Product
- 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, GF-UE160-AL5.
- Where it went
- Worldwide - US Nationwide distribution.
- How much
- 680 units
Choleodochoscope. Model Numbers: CHF-BP30, CHF-CB30L, CHF-P60.
Z-0330-2024 · Class III · reported 2023-11-29 · Ongoing
- Why it was recalled
- 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
- Product
- Choleodochoscope. Model Numbers: CHF-BP30, CHF-CB30L, CHF-P60.
- Where it went
- Worldwide - US Nationwide distribution.
- How much
- 3 units
Bronchoscope-for endoscopy and endoscopic surgery within the airways and tracheobronchial tree. Model Number
Z-0327-2024 · Class II · reported 2023-11-29 · Ongoing
- Why it was recalled
- 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
- Product
- 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-H190, BF-MP190F, BF-MP60, BF-P150, BF-P190, BF-P60, BF-Q170, BF-Q190, BF-XP190, BF-XP60, BF-XT160, BF-XT190. 510(k)s: K023984, K121959, K963033, K172726, K201758, K033225, K183419.
- Where it went
- Worldwide - US Nationwide distribution.
- How much
- 1123 units
Rhinolaryngoscope-for endoscopic diagnosis and treatment within the nasal lumens and airway anatomy (including
Z-0332-2024 · Class II · reported 2023-11-29 · Ongoing
- Why it was recalled
- 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
- Product
- 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.
- Where it went
- Worldwide - US Nationwide distribution.
- How much
- 46 units
Colonoscope-indicated for use within the lower digestive tract (including the anus, rectum, sigmoid colon, col
Z-0341-2024 · Class II · reported 2023-11-29 · Ongoing
- Why it was recalled
- 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
- Product
- Colonoscope-indicated for use within the lower digestive tract (including the anus, rectum, sigmoid colon, colon, and ileocecal valve). Model Numbers: PCF-H180AI, PCF-H180AL, PCF-H190DI, PCF-H190DL, PCF-H190I, PCF-H190L, PCF-H190TI, PCF-H190TL, PCF-HQ190I, PCF-HQ190L, PCF-PH190I, PCF-PH190L, PCF-Q180AI, PCF-Q180AL, PCF-S.
- Where it went
- Worldwide - US Nationwide distribution.
- How much
- 3101 units
Bronchoscope - Ultrasonic: endoscopic real-time ultrasonic imaging, ultrasound guided needle aspiration and ot
Z-0328-2024 · Class II · reported 2023-11-29 · Ongoing
- Why it was recalled
- 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
- Product
- Bronchoscope - Ultrasonic: endoscopic real-time ultrasonic imaging, ultrasound guided needle aspiration and other endoscopic procedures within the airways, trancheobronchial tree, esophagus and surrounding organs Model Numbers: BF-UC180F, BF-UC190F.
- Where it went
- Worldwide - US Nationwide distribution.
- How much
- 823 units
Ureteralscope- for endoscopic diagnosis and treatment within the ureter, kidney and biliary tract (common bile
Z-0347-2024 · Class II · reported 2023-11-29 · Ongoing
- Why it was recalled
- 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
- Product
- Ureteralscope- for endoscopic diagnosis and treatment within the ureter, kidney and biliary tract (common bile duct and hepatic duct). Model Numbers: URF-P6, URF-P6R.
- Where it went
- Worldwide - US Nationwide distribution.
- How much
- 1577 units
Transnasal esophagovideoscope-For endoscopy and endoscopic surgery within the esophagus and stomach. Model Nu
Z-0344-2024 · Class II · reported 2023-11-29 · Ongoing
- Why it was recalled
- 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
- Product
- Transnasal esophagovideoscope-For endoscopy and endoscopic surgery within the esophagus and stomach. Model Number: PEF-V.
- Where it went
- Worldwide - US Nationwide distribution.
- How much
- 25 units
Cystonephroscope-endoscopic diagnosis and treatment within the bladder, urethra, and kidney Model Numbers: CY
Z-0331-2024 · Class II · reported 2023-11-29 · Ongoing
- Why it was recalled
- 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
- Product
- Cystonephroscope-endoscopic diagnosis and treatment within the bladder, urethra, and kidney Model Numbers: CYF-5, CYF-VH, CYF-VHR.
- Where it went
- Worldwide - US Nationwide distribution.
- How much
- 1243 units
Tracheal videoscope- For airway management, which includes observation to access airway anatomy, endotracheal/
Z-0339-2024 · Class II · reported 2023-11-29 · Ongoing
- Why it was recalled
- 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
- Product
- Tracheal videoscope- For airway management, which includes observation to access airway anatomy, endotracheal/endobronchial intubation and management. Model Number: LF-V.
- Where it went
- Worldwide - US Nationwide distribution.
- How much
- 61 units
Hysterovideoscope-For endoscopic diagnosis within the uterus Model Number: HYF-V.
Z-0336-2024 · Class II · reported 2023-11-29 · Ongoing
- Why it was recalled
- 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
- Product
- Hysterovideoscope-For endoscopic diagnosis within the uterus Model Number: HYF-V.
- Where it went
- Worldwide - US Nationwide distribution.
- How much
- 27 units
Gastrointestinal videoscope-indicated for use within the upper digestive tract (including the esophagus, stoma
Z-0334-2024 · Class II · reported 2023-11-29 · Ongoing
- Why it was recalled
- 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
- Product
- Gastrointestinal videoscope-indicated for use within the upper digestive tract (including the esophagus, stomach, and duodenum). Model Numbers: 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. 510(k) Numbers: K112680, K954451, K051645, K100584, K111756, K011151, K123317.
- Where it went
- Worldwide - US Nationwide distribution.
- How much
- 3627 units
Duodenovideoscope-EndoTherapy accessories (such as a biopsy forceps), and other ancillary equipment for endosc
Z-0346-2024 · Class II · reported 2023-11-29 · Ongoing
- Why it was recalled
- 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
- Product
- Duodenovideoscope-EndoTherapy accessories (such as a biopsy forceps), and other ancillary equipment for endoscopy and endoscopic surgery Model Numbers: TJF-145, TJF-150, TJF-Q180V, TJF-Q190V.
- Where it went
- Worldwide - US Nationwide distribution.
- How much
- 0 units
Hysterofiberscope-For endoscopic diagnosis within the uterus. Model Number: HYF-XP.
Z-0337-2024 · Class II · reported 2023-11-29 · Ongoing
- Why it was recalled
- 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
- Product
- Hysterofiberscope-For endoscopic diagnosis within the uterus. Model Number: HYF-XP.
- Where it went
- Worldwide - US Nationwide distribution.
- How much
- 16 units
Small intestinal videoscope-For endoscopy and endoscopic surgery within the upper digestive tract (including t
Z-0343-2024 · Class II · reported 2023-11-29 · Ongoing
- Why it was recalled
- 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
- Product
- Small intestinal videoscope-For endoscopy and endoscopic surgery within the upper digestive tract (including the esophagus, stomach, duodenum, and small intestine) by oral insertion or the lower digestive tract (including the anus, rectum, sigmoid colon, colon, ileocecal valve, and small intestine) by anal insertion. - Model Number: SIF-Q180.
- Where it went
- Worldwide - US Nationwide distribution.
- How much
- 32 units
Colonoscope: for endoscopy and endoscopic surgery within the lower digestive tract (including the anus, rectum
Z-0329-2024 · Class II · reported 2023-11-29 · Ongoing
- Why it was recalled
- 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
- Product
- Colonoscope: for endoscopy and endoscopic surgery within the lower digestive tract (including the anus, rectum, sigmoid colon, colon and ileocecal valve). Model Numbers: 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. 510(k) Numbers: K954451, K112680, K100584, K051645, K111756, K001241, K911278.
- Where it went
- Worldwide - US Nationwide distribution.
- How much
- 3344 units
Ultrasonic gastrovideoscope-Real time ultrasound imaging,ultrasound guided needle aspiration and other endosco
Z-0345-2024 · Class II · reported 2023-11-29 · Ongoing
- Why it was recalled
- 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
- Product
- Ultrasonic gastrovideoscope-Real time ultrasound imaging,ultrasound guided needle aspiration and other endoscopic procedures within the upper gastrointestinal tract and surrounding organs Model Number: TGF-UC180J.
- Where it went
- Worldwide - US Nationwide distribution.
- How much
- 5 units
Mobile airway scope-diagnosis and observation to access airway anatomy, endotracheal/endobronchial intubation
Z-0340-2024 · Class II · reported 2023-11-29 · Ongoing
- Why it was recalled
- 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
- Product
- Mobile airway scope-diagnosis and observation to access airway anatomy, endotracheal/endobronchial intubation and management. Model Numbers: MAF-DM2, MAF-GM, MAF-GM2, MAF-TM, MAF-TM2.
- Where it went
- Worldwide - US Nationwide distribution.
- How much
- 33 units
Hysteroscope-For endoscopic diagnosis within the uterus Model Number: HYF-1T.
Z-0335-2024 · Class II · reported 2023-11-29 · Ongoing
- Why it was recalled
- 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
- Product
- Hysteroscope-For endoscopic diagnosis within the uterus Model Number: HYF-1T.
- Where it went
- Worldwide - US Nationwide distribution.
- How much
- 0 units
Uretero-reno fiberscope-For endoscopic diagnosis and treatment within the ureter and kidney. Model Numbers:
Z-0348-2024 · Class II · reported 2023-11-29 · Ongoing
- Why it was recalled
- 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
- Product
- Uretero-reno fiberscope-For endoscopic diagnosis and treatment within the ureter and kidney. Model Numbers: URF-P7, URF-P7R, URF-V2, URF-V2R, URF-V3, URF-V3R.
- Where it went
- Worldwide - US Nationwide distribution.
- How much
- N/A
Showing the 30 most recent of 31. The rest are searchable at the FDA enforcement report database.
Read these counts with three things in mind
A firm with more recalls usually makes more products. A contract packer runs
hundreds of lines. It will out-recall a company with one product whatever either
does. This is not a safety ranking.
Most recalls here are voluntary. A firm found its own fault and pulled the stock.
That is the system working. It lands in this database looking the same as a recall
the FDA had to push for.
Terminated means the FDA considers the recall finished. It is not a verdict.
It does not mean anyone was harmed.
Source: openFDA enforcement reports, retrieved 2026-08-05. FDA dataset last updated 2026-07-29.
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