Manufacturer

Olympus Corporation of the Americas

332 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.

76–100 of 332

HighFDA (Devices)·Z-1292-2026·2026-02-11
Single Use Sphincterotomes recalled for potential deformation and performance loss
Olympus Corporation is recalling approximately 2,344 Single Use 3-Lumen Sphincterotome V devices due to manufacturing defects that could cause deformation and loss of surgical performance.
Product
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-3030 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
HighFDA (Devices)·Z-1283-2026·2026-02-11
Olympus Sphincterotome Devices Recalled for Manufacturing Defect in Thermoforming Process
Olympus recalls 1,504 Single Use Sphincterotome V devices due to incomplete thermoforming. Affected devices could deform and lose performance during surgical use.
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
HighFDA (Devices)·Z-1289-2026·2026-02-11
Olympus Disposable Sphincterotome Recalled for Potential Performance Loss
Olympus recalls 1,490 Disposable Triple Lumen Sphincterotomes due to a manufacturing defect where improper thermoforming could cause the devices to deform and lose performance during surgical use.
Product
Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0730 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
HighFDA (Devices)·Z-1268-2026·2026-02-11
Olympus Sphincterotome Defective Units Recalled for Potential Device Deformation
Olympus is recalling CleverCut Single Use 3-Lumen Sphincterotomes (Model KD-V411M-0320) because some units may not have undergone proper thermoforming, potentially causing device deformation and performance loss.
Product
Brand Name: CleverCut Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-0320; 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
HighFDA (Devices)·Z-1294-2026·2026-02-11
Olympus Disposable Sphincterotome Recall for Deformation and Performance Loss
Olympus Corporation is recalling Disposable Triple Lumen Sphincterotomes (Model KD-401Q-0725) because some units did not undergo proper thermoforming during manufacturing and could deform and lose performance.
Product
Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0725 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
HighFDA (Devices)·Z-1295-2026·2026-02-11
FDA Recalls Single Use Sphincterotome Due to Deformation Risk
Olympus is recalling Single Use 3-Lumen Sphincterotome V instruments (Model KD-V411M-3020) because some devices may not have undergone proper thermoforming, causing potential deformation and performance loss. The recall affects 650 units.
Product
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-3020 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
HighFDA (Devices)·Z-1269-2026·2026-02-11
Olympus Single Use Sphincterotome V Recalled for Potential Deformation
Olympus is recalling its Single Use Sphincterotome V devices that may not have undergone proper thermoforming, which could cause them to deform and lose performance.
Product
Product Name: Single Use Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC431Q-0720 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
HighFDA (Devices)·Z-1276-2026·2026-02-11
Olympus Sphincterotome Devices Recalled for Deformation and Loss of Performance
Olympus is recalling over 17,600 3-Lumen Sphincterotome V devices because some units did not undergo proper thermoforming, which could cause them to deform and lose performance.
Product
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V431M-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 current.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1287-2026·2026-02-11
Disposable Sphincterotome Recall by Olympus for Potential Deformation and Performance Loss
Olympus is recalling 886 units of its Disposable Triple Lumen Sphincterotome (Model KD-401Q-0330) because some devices may not have undergone proper thermoforming and could deform and lose performance during use.
Product
Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0330 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
HighFDA (Devices)·Z-1274-2026·2026-02-11
Olympus Single Use 3-Lumen Sphincterotome V Recalled Due to Deformation Risk
Olympus Corporation is recalling the Single Use 3-Lumen Sphincterotome V surgical device due to a manufacturing defect where some devices may not have undergone proper thermoforming, potentially causing deformation and performance loss during surgical procedures.
Product
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-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 current.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1285-2026·2026-02-11
FDA Recalls Disposable Triple Lumen Sphincterotome Due to Thermoforming Defect
Olympus recalls approximately 125 units of the Disposable Triple Lumen Sphincterotome (Model KD-411Q-0720) worldwide due to thermoforming defects that could cause device deformation and loss of performance.
Product
Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-411Q-0720 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
HighFDA (Devices)·Z-1223-2026·2026-02-11
Olympus electrosurgical knife recalled due to deterioration and tip breakage risk
Olympus is recalling its KD-645 electrosurgical knife due to deterioration of the cutting knife that can cause overheating, burning, and tip breakage during endoscopic surgery. A total of 3,361 units have been distributed nationwide.
Product
Brand Name: Single Use Electrosurgical Knife KD-645 Product Name: Olympus Single Use Electrosurgical Knife KD-645 Model/Catalog Number: KD-645L Product Description: An electrosurgical device consisting of a handpiece with mechanical and/or electrical controls, and a monopolar
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1291-2026·2026-02-11
Olympus Sphincterotome Devices Recalled for Potential Deformation and Performance Loss
Olympus is recalling Single Use 3-Lumen Sphincterotome V devices that may not have undergone proper thermoforming, which could cause deformation and performance loss during use.
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
HighFDA (Devices)·Z-1293-2026·2026-02-11
Olympus Sphincterotome Devices Recalled for Deformation and Performance Loss
Olympus recalls 999 units of Disposable Triple Lumen Sphincterotomes due to manufacturing defects. Devices that did not undergo proper thermoforming may deform and lose performance during use.
Product
Brand Name: Disposable Triple Lumen Sphincterotome Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0320 Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-fr
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1222-2026·2026-02-11
FDA Recalls Olympus Electrosurgical Knife Models for Tip Breakage
Olympus Corporation is recalling the KD-640L electrosurgical knife nationwide due to deterioration causing overheating, burning, and tip breakage risk during surgery.
Product
Brand Name: Single Use Electrosurgical Knife Product Name: Olympus Single Use Electrosurgical Knife KD-640L Model/Catalog Number: KD640-L Product Description: An electrosurgical device consisting of a handpiece with mechanical and/or electrical controls, and a monopolar electr
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1297-2026·2026-02-11
Olympus Sphincterotome Recall Due to Potential Deformation and Performance Loss
Olympus is recalling 1,474 units of the Single Use 3-Lumen Sphincterotome V distributed outside the US. Some devices may not have undergone proper thermoforming, which could cause deformation and performance loss.
Product
Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC411Q-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
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1284-2026·2026-02-11
Olympus Single-Use Sphincterotome V Recalled for Manufacturing Thermoforming Defect
Olympus Corporation recalls 93 Single-Use 3-Lumen Sphincterotome V devices due to improper thermoforming that may cause deformation and performance loss. Affected devices were distributed nationwide and internationally.
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
HighFDA (Devices)·Z-1275-2026·2026-02-11
Olympus Sphincterotome V devices may deform and lose surgical performance
Olympus is recalling approximately 11,779 Single Use 3-Lumen Sphincterotome V surgical instruments distributed in the US. Some devices may not have undergone proper thermoforming, which could cause them to deform and lose performance during use.
Product
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V431M-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
HighFDA (Devices)·Z-1279-2026·2026-02-11
Olympus Sphincterotome V Surgical Instrument Recalled for Deformation Risk
Olympus Corporation is recalling 10,257 units of Single Use 3-Lumen Sphincterotome V endoscopic instruments. Some devices did not undergo thermoforming during manufacturing and could deform and lose performance.
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
HighFDA (Devices)·Z-1278-2026·2026-02-11
Olympus Sphincterotome V Recalled Due to Potential Device Deformation
Olympus recalls single-use sphincterotomes that may deform and lose performance if not properly thermoformed during manufacturing. No injuries have been reported.
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
HighFDA (Devices)·Z-1288-2026·2026-02-11
Olympus Disposable Triple Lumen Sphincterotome devices recalled for deformation risk
Olympus recalls Disposable Triple Lumen Sphincterotome Model KD-401Q-0720 devices due to manufacturing defects that could cause device deformation and loss of performance during medical procedures.
Product
Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0720 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
HighFDA (Devices)·Z-1286-2026·2026-02-11
Olympus Disposable Triple Lumen Sphincterotome Recall Due to Manufacturing Defect
Olympus is recalling 887 units of the Disposable Triple Lumen Sphincterotome due to a manufacturing defect. Devices that did not undergo thermoforming could deform and lose performance during use.
Product
Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-411Q-0730 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
HighFDA (Devices)·Z-1277-2026·2026-02-11
Olympus Sphincterotome V devices recalled due to performance loss
Olympus is recalling 4,183 Single Use 3-Lumen Sphincterotome V devices because some units did not undergo thermoforming, which could cause deformation and loss of performance.
Product
Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC431Q-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
HighFDA (Devices)·Z-1280-2026·2026-02-11
Olympus Sphincterotome Devices Recalled for Potential Deformation and Performance Loss
Olympus Corporation is recalling Single Use 3-Lumen Sphincterotome V devices (Model KD-VC411Q-0320) because some units did not undergo proper thermoforming and could deform or lose performance during use.
Product
Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC411Q-0320; 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
HighFDA (Devices)·Z-1296-2026·2026-02-11
FDA Recalls 3-Lumen Sphincterotome Devices for Deformation Risk
Olympus has recalled its Single Use 3-Lumen Sphincterotome V devices due to manufacturing defects. Devices that did not undergo proper thermoforming may deform and lose performance during endoscopic procedures.
Product
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-3025 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