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Product Description
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Recall Class
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FDA Recall Posting Date
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Recalling Firm
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Z-0330-2024 - Choleodochoscope. Model Numbers: CHF-BP30, CHF-CB30L, CHF-P60.
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3
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11/17/2023
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Aizu Olympus Co., Ltd.
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Z-0328-2024 - Bronchoscope - Ultrasonic: endoscopic real-time ultrasonic imaging,
ultrasound guided needle aspiration and other endoscopic procedures within the
airways, trancheobronchial tree, esophagus and surrou...
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2
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11/17/2023
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Aizu Olympus Co., Ltd.
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Z-0329-2024 - 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-H170...
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2
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11/17/2023
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Aizu Olympus Co., Ltd.
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Z-0331-2024 - Cystonephroscope-endoscopic diagnosis and treatment within the bladder, urethra, and kidney
Model Numbers: CYF-5, CYF-VH, CYF-VHR.
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2
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11/17/2023
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Aizu Olympus Co., Ltd.
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Z-0332-2024 - 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.
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2
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11/17/2023
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Aizu Olympus Co., Ltd.
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Z-0333-2024 - 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.
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2
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11/17/2023
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Aizu Olympus Co., Ltd.
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Z-0334-2024 - 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...
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2
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11/17/2023
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Aizu Olympus Co., Ltd.
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Z-0335-2024 - Hysteroscope-For endoscopic diagnosis within the uterus
Model Number: HYF-1T.
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2
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11/17/2023
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Aizu Olympus Co., Ltd.
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Z-0336-2024 - Hysterovideoscope-For endoscopic diagnosis within the uterus
Model Number: HYF-V.
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2
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11/17/2023
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Aizu Olympus Co., Ltd.
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Z-0337-2024 - Hysterofiberscope-For endoscopic diagnosis within the uterus.
Model Number: HYF-XP.
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2
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11/17/2023
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Aizu Olympus Co., Ltd.
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