Manufacturer

Olympus Corporation of the Americas

337 recalls in our database name Olympus Corporation of the Americas as the manufacturing or recalling firm.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

101–125 of 337

Severity pendingFDA (Devices)·Z-1283-2026·2026-02-11
Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC4
Pending LLM rewrite. Source: FDA_DEVICE Z-1283-2026.
Product
Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC433Q-0720; Software Version: N/A Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency
Category
Medical Device
Distribution
Distributed nationwide
Severity pendingFDA (Devices)·Z-1291-2026·2026-02-11
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-1530 Product Desc
Pending LLM rewrite. Source: FDA_DEVICE Z-1291-2026.
Product
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-1530 Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.
Category
Medical Device
Distribution
Distributed nationwide
Severity pendingFDA (Devices)·Z-1273-2026·2026-02-11
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-0725; Software V
Pending LLM rewrite. Source: FDA_DEVICE Z-1273-2026.
Product
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-0725; Software Version: N/A Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.
Category
Medical Device
Distribution
Distributed nationwide
Severity pendingFDA (Devices)·Z-1290-2026·2026-02-11
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-1520 Product Desc
Pending LLM rewrite. Source: FDA_DEVICE Z-1290-2026.
Product
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-1520 Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.
Category
Medical Device
Distribution
Distributed nationwide
Severity pendingFDA (Devices)·Z-1279-2026·2026-02-11
Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC4
Pending LLM rewrite. Source: FDA_DEVICE Z-1279-2026.
Product
Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC411Q-0730; Software Version: N/A Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency
Category
Medical Device
Distribution
Distributed nationwide
Severity pendingFDA (Devices)·Z-1272-2026·2026-02-11
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-0720; Software V
Pending LLM rewrite. Source: FDA_DEVICE Z-1272-2026.
Product
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-0720; Software Version: N/A Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.
Category
Medical Device
Distribution
Distributed nationwide
Severity pendingFDA (Devices)·Z-1284-2026·2026-02-11
Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number:KD-VC43
Pending LLM rewrite. Source: FDA_DEVICE Z-1284-2026.
Product
Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number:KD-VC433Q-0730; Software Version: N/A Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency c
Category
Medical Device
Distribution
Distributed nationwide
Severity pendingFDA (Devices)·Z-1278-2026·2026-02-11
Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC4
Pending LLM rewrite. Source: FDA_DEVICE Z-1278-2026.
Product
Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC411Q-0720; Software Version: N/A Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency
Category
Medical Device
Distribution
Distributed nationwide
Severity pendingFDA (Devices)·Z-0579-2026·2025-12-03
Brand Name: EVIS EXERA III Duodenovideoscope Product Name: Olympus TJF-Q190V Model/Catalog Number:
Pending LLM rewrite. Source: FDA_DEVICE Z-0579-2026.
Product
Brand Name: EVIS EXERA III Duodenovideoscope Product Name: Olympus TJF-Q190V Model/Catalog Number: TJF-Q190V Product Description: This instrument is intended to be used with an Olympus video system center, light source, documentation equipment, monitor, EndoTherapy accessorie
Category
Medical Device
Distribution
Distributed nationwide
Severity pendingFDA (Devices)·Z-0570-2026·2025-12-03
Brand Name: Single Use Ligating Device Product Name: Olympus HX-400U-30 Model/Catalog Number: HX-4
Pending LLM rewrite. Source: FDA_DEVICE Z-0570-2026.
Product
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 a nylon loop snare.
Category
Medical Device
Distribution
0 states
Severity pendingFDA (Devices)·Z-0572-2026·2025-11-26
Brand Name: EZDilate Nephrostomy Balloon Catheter and Inflation Device Kit Product Name: Olympus Ne
Pending LLM rewrite. Source: FDA_DEVICE Z-0572-2026.
Product
Brand Name: EZDilate Nephrostomy Balloon Catheter and Inflation Device Kit Product Name: Olympus Nephro-EZDilate Nephrostomy Balloon Catheter Model/Catalog Number: BPCN0815K Product Description: The Nephro-EZDilate nephrostomy balloon catheter is a reinforced catheter attached
Category
Medical Device
Distribution
6 states
Severity pendingFDA (Devices)·Z-0452-2026·2025-11-19
Brand Name: Lithotriptor, Ultrasonic Product Name: ShockPulse Lithotripsy Transducer Model/Catalog
Pending LLM rewrite. Source: FDA_DEVICE Z-0452-2026.
Product
Brand Name: Lithotriptor, Ultrasonic Product Name: ShockPulse Lithotripsy Transducer Model/Catalog Number: SPL-T Product Description: The ShockPulse Lithotripsy System is an electromechanical device capable of fragmenting calculi and aspirating stone debris. The ShockPulse tra
Category
Medical Device
Distribution
Distributed nationwide
Severity pendingFDA (Devices)·Z-0483-2026·2025-11-19
Brand Name: Olympus Single Use Single Use Electrosurgical Snare SD-400 Product Name: Single Use Sin
Pending LLM rewrite. Source: FDA_DEVICE Z-0483-2026.
Product
Brand Name: Olympus Single Use Single Use Electrosurgical Snare SD-400 Product Name: Single Use Single Use Electrosurgical Snare Model/Catalog Number: SD-U400U-15 Product Description: These instruments have been designed to be used with an Olympus endoscope for the removal and
Category
Medical Device
Distribution
Distributed nationwide
Severity pendingFDA (Devices)·Z-0482-2026·2025-11-19
Brand Name: Olympus Single Use Electrosurgical Snare SD-400 Product Name: Single Use Electrosurgica
Pending LLM rewrite. Source: FDA_DEVICE Z-0482-2026.
Product
Brand Name: Olympus Single Use Electrosurgical Snare SD-400 Product Name: Single Use Electrosurgical Snare Model/Catalog Number: SD-400U-10 Product Description: These instruments have been designed to be used with an Olympus endoscope for the removal and/or cauterization of di
Category
Medical Device
Distribution
Distributed nationwide
Severity pendingFDA (Devices)·Z-0046-2026·2025-10-22
EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE 1T180
Pending LLM rewrite. Source: FDA_DEVICE Z-0046-2026.
Product
EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE 1T180
Category
Medical Device
Distribution
Distributed nationwide
Severity pendingFDA (Devices)·Z-0055-2026·2025-10-22
BRONCHOVIDEOSCOPE OLYMPUS BF TYPE P150
Pending LLM rewrite. Source: FDA_DEVICE Z-0055-2026.
Product
BRONCHOVIDEOSCOPE OLYMPUS BF TYPE P150
Category
Medical Device
Distribution
Distributed nationwide
Severity pendingFDA (Devices)·Z-0067-2026·2025-10-22
OES BRONCHOFIBERSCOPE OLYMPUS BF TYPE XT40
Pending LLM rewrite. Source: FDA_DEVICE Z-0067-2026.
Product
OES BRONCHOFIBERSCOPE OLYMPUS BF TYPE XT40
Category
Medical Device
Distribution
Distributed nationwide
Severity pendingFDA (Devices)·Z-0066-2026·2025-10-22
EVIS EXERA b BRONCHOVIDEOSCOPE OLYMPUS BF-XT190
Pending LLM rewrite. Source: FDA_DEVICE Z-0066-2026.
Product
EVIS EXERA b BRONCHOVIDEOSCOPE OLYMPUS BF-XT190
Category
Medical Device
Distribution
Distributed nationwide
Severity pendingFDA (Devices)·Z-0059-2026·2025-10-22
BRONCHOFIBERSCOPE OLYMPUS BF TYPE PE2
Pending LLM rewrite. Source: FDA_DEVICE Z-0059-2026.
Product
BRONCHOFIBERSCOPE OLYMPUS BF TYPE PE2
Category
Medical Device
Distribution
Distributed nationwide
Severity pendingFDA (Devices)·Z-0057-2026·2025-10-22
EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-P190
Pending LLM rewrite. Source: FDA_DEVICE Z-0057-2026.
Product
EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-P190
Category
Medical Device
Distribution
Distributed nationwide
Severity pendingFDA (Devices)·Z-0051-2026·2025-10-22
EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE 1TQ180
Pending LLM rewrite. Source: FDA_DEVICE Z-0051-2026.
Product
EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE 1TQ180
Category
Medical Device
Distribution
Distributed nationwide
Severity pendingFDA (Devices)·Z-0058-2026·2025-10-22
OES BRONCHOFIBERSCOPE OLYMPUS BF TYPE P60
Pending LLM rewrite. Source: FDA_DEVICE Z-0058-2026.
Product
OES BRONCHOFIBERSCOPE OLYMPUS BF TYPE P60
Category
Medical Device
Distribution
Distributed nationwide
Severity pendingFDA (Devices)·Z-0054-2026·2025-10-22
OES BRONCHOFIBERSCOPE OLYMPUS BF TYPE MP60
Pending LLM rewrite. Source: FDA_DEVICE Z-0054-2026.
Product
OES BRONCHOFIBERSCOPE OLYMPUS BF TYPE MP60
Category
Medical Device
Distribution
Distributed nationwide
Severity pendingFDA (Devices)·Z-0064-2026·2025-10-22
BRONCHOFIBERSCOPE OLYMPUS BF TYPE TE2
Pending LLM rewrite. Source: FDA_DEVICE Z-0064-2026.
Product
BRONCHOFIBERSCOPE OLYMPUS BF TYPE TE2
Category
Medical Device
Distribution
Distributed nationwide
Severity pendingFDA (Devices)·Z-0047-2026·2025-10-22
OES BRONCHOFIBERSCOPE OLYMPUS BF TYPE 1T60
Pending LLM rewrite. Source: FDA_DEVICE Z-0047-2026.
Product
OES BRONCHOFIBERSCOPE OLYMPUS BF TYPE 1T60
Category
Medical Device
Distribution
Distributed nationwide