Olympus Corporation of the Americas
232 recalls on record · Latest: Feb 11, 2026
FDA Devices Moderate Feb 11, 2026
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-1520 Product Description: These instruments have been designed to …
FDA Devices Moderate Feb 11, 2026
Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0330 Product Description: These instruments have been designed t…
FDA Devices Moderate Feb 11, 2026
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-0330; Software Version: N/A Product Description: These instrumen…
FDA Devices Moderate Feb 11, 2026
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-0725; Software Version: N/A Product Description: These instrumen…
FDA Devices Moderate Feb 11, 2026
Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0730 Product Description: These instruments have been designed t…
FDA Devices Moderate Feb 11, 2026
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-3025 Product Description: These instruments have been designed to …
FDA Devices Moderate Feb 11, 2026
Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-431Q-0720 Product Description: These instruments have been designed t…
FDA Devices Moderate Feb 11, 2026
Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0720 Product Description: These instruments have been designed t…
FDA Devices Moderate Feb 11, 2026
Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC411Q-0725; Software Version: N/A Product Descrip…
FDA Devices Moderate Feb 11, 2026
Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-411Q-0730 Product Description: These instruments have been designed t…
FDA Devices Moderate Feb 11, 2026
Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC411Q-0720; Software Version: N/A Product Descrip…
FDA Devices Moderate Feb 11, 2026
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V431M-0720; Software Version: N/A Product Description: These instrumen…
FDA Devices Moderate Feb 11, 2026
Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC431Q-0730; Software Version: N/A Product Descri…
FDA Devices Moderate Feb 11, 2026
Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-411Q-0720 Product Description: These instruments have been designed t…
FDA Devices Moderate Feb 11, 2026
Brand Name: CleverCut Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-0320; Software Version: N/A Product Descri…
FDA Devices Moderate Feb 11, 2026
Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number:KD-VC433Q-0730; Software Version: N/A Product Descript…
FDA Devices Moderate Feb 11, 2026
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-0730; Software Version: N/A Product Description: These instrumen…
FDA Devices Moderate Feb 11, 2026
Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC411Q-0320; Software Version: N/A Product Descrip…
FDA Devices Moderate Feb 11, 2026
Brand Name: Single Use Electrosurgical Knife Product Name: Olympus Single Use Electrosurgical Knife KD-640L Model/Catalog Number: KD640-L Product …
FDA Devices Moderate Feb 11, 2026
Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC411Q-0730; Software Version: N/A Product Descrip…
FDA Devices Moderate Feb 11, 2026
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-3030 Product Description: These instruments have been designed to …
FDA Devices Moderate Feb 11, 2026
Brand Name: Single Use Electrosurgical Knife KD-645 Product Name: Olympus Single Use Electrosurgical Knife KD-645 Model/Catalog Number: KD-645L Pr…
FDA Devices Moderate Feb 11, 2026
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-3020 Product Description: These instruments have been designed to …
FDA Devices Moderate Feb 11, 2026
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V431M-0730; Software Version: N/A Product Description: These instrumen…
FDA Devices Moderate Feb 11, 2026
Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC411Q-0330; Software Version: N/A Product Descrip…
FDA Devices Critical Dec 3, 2025
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…
FDA Devices Moderate Nov 26, 2025
Brand Name: EZDilate Nephrostomy Balloon Catheter and Inflation Device Kit Product Name: Olympus Nephro-EZDilate Nephrostomy Balloon Catheter Model…
FDA Devices Moderate Nov 19, 2025
Brand Name: Lithotriptor, Ultrasonic Product Name: ShockPulse Lithotripsy Transducer Model/Catalog Number: SPL-T Product Description: The ShockPul…
FDA Devices Moderate Nov 19, 2025
Brand Name: Olympus Single Use Single Use Electrosurgical Snare SD-400 Product Name: Single Use Single Use Electrosurgical Snare Model/Catalog Numb…
FDA Devices Critical Oct 22, 2025
EVIS EXERA BRONCHOVIDEOSCOPE OLYMPUS BF TYPE XT160
FDA Devices Critical Oct 22, 2025
OES BRONCHOFIBERSCOPE OLYMPUS BF TYPE XT40
FDA Devices Critical Oct 22, 2025
BRONCHOFIBERSCOPE OLYMPUS BF TYPE TE2
FDA Devices Critical Oct 22, 2025
OES BRONCHOFIBERSCOPE OLYMPUS BF TYPE 1T60
FDA Devices Critical Oct 22, 2025
BRONCHOVIDEOSCOPE OLYMPUS BF TYPE P150
FDA Devices Critical Oct 22, 2025
EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE 1T180
FDA Devices Critical Oct 22, 2025
BRONCHOVIDEOSCOPE OLYMPUS BF-1TH1100
FDA Devices Critical Oct 22, 2025
EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE Q180-AC
FDA Devices Critical Oct 22, 2025
BRONCHOVIDEOSCOPE OLYMPUS BF-1TQ170
FDA Devices Critical Oct 22, 2025
BRONCHOFIBERSCOPE OLYMPUS BF TYPE PE2
FDA Devices Critical Oct 22, 2025
EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-H190
FDA Devices Critical Oct 22, 2025
EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE P180
FDA Devices Critical Oct 22, 2025
BRONCHOVIDEOSCOPE OLYMPUS BF-H1100
FDA Devices Critical Oct 22, 2025
BRONCHOVIDEOSCOPE OLYMPUS BF TYPE 1T150
FDA Devices Critical Oct 22, 2025
EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-Q190
FDA Devices Critical Sep 17, 2025
ViziShot 2FLEX. Single Use Aspiration Needle. Model Number: NA-U403SX-4019. The ViziShot 2 FLEX tissue biopsy device is made up of four main parts…
FDA Devices Moderate Aug 27, 2025
Electrosurgical, Cutting and Coagulation and Accessories. Electrosurgical Generator ESG-410 Surgical Energy Platform (SEP). Model Number: WA91327U. …
FDA Devices Moderate Jul 30, 2025
Ellik Evacuator. Model Number: 194. The Ellik Evacuator and adapter accessories are compatible with Gyrus ACMI Elite and Elite 2 Resection Sheaths.
FDA Devices Moderate Jul 30, 2025
Tubing for Male Connector 194, Ellik Evacuator. Model Number: 190-4. The Ellik Evacuator and adapter accessories are compatible with Gyrus ACMI El…
FDA Devices Moderate Jul 30, 2025
Cone with Male Tubing, Non-Locking, Ellik Evacuator. Model Number: 191-NRS. The Ellik Evacuator and adapter accessories are compatible with Gyrus…
FDA Devices Moderate Jul 30, 2025