Brand
Olympus Corporation Of The Americas Recalls
266 recalls on record. Search official CPSC, FDA, and USDA datasets for every recall issued for Olympus Corporation Of The Americas.
266Total Recalls
37Critical
3.7MUnits Affected
Mar 25, 2026Most Recent
All Recalls
Every Olympus Corporation Of The Americas Recall
Sorted by most recent. Click any recall for full details.
266 recalls
High RiskFDA
Olympus Corporation Of The Americas
OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2115.
Medical Devices2,089 affectedMar 25, 2026
High RiskFDA
Olympus Corporation Of The Americas
OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2113.
Medical Devices8,936 affectedMar 25, 2026
High RiskFDA
Olympus Corporation Of The Americas
OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2119.
Medical Devices741 affectedMar 25, 2026
High RiskFDA
Olympus Corporation Of The Americas
OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2114.
Medical Devices2,143 affectedMar 25, 2026
High RiskFDA
Olympus Corporation Of The Americas
OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2138.
Medical Devices808 affectedMar 25, 2026
High RiskFDA
Olympus Corporation Of The Americas
OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2118.
Medical Devices1,259 affectedMar 25, 2026
High RiskFDA
Olympus Corporation Of The Americas
OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2112
Medical Devices8,994 affectedMar 25, 2026
High RiskFDA
Olympus Corporation Of The Americas
Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 45cm. Model Number: TB2-0545FC.
Medical Devices490 affectedMar 23, 2026
High RiskFDA
Olympus Corporation Of The Americas
Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 20cm. Model Number: TB2-0520FC.
Medical Devices830 affectedMar 23, 2026
High RiskFDA
Olympus Corporation Of The Americas
Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 35cm. Model Number: TB2-0535FC.
Medical Devices3,360 affectedMar 23, 2026
CriticalFDA
Olympus Corporation Of The Americas
Brand Name: Olympus SOLTIVE Premium SuperPulsed Laser System Product Name: SOLTIVE Premium Laser System TFL-PLS Model/Catalog Number: T...
Medical Devices408 affectedFeb 27, 2026
High RiskFDA
Olympus Corporation Of The Americas
Brand Name: Olympus PKS Cutting Forceps, 5mm 33cm Product Name: PKS Cutting Forceps Model/Catalog Number: 3005PK Product Description: ...
Surgical Devices93 affectedFeb 25, 2026
High RiskFDA
Olympus Corporation Of The Americas
Brand Name: Olympus PKS Cutting Forceps w/Cord, 5mm 24cm Product Name: PKS Cutting Forceps Model/Catalog Number: 920000PK Product Desc...
Surgical Devices7 affectedFeb 25, 2026
High RiskFDA
Olympus Corporation Of The Americas
Brand Name: Olympus PK Cutting Forceps, 5mm 33cm Product Name: PK Cutting Forceps Model/Catalog Number: PK-CF0533 Product Description:...
Surgical Devices444 affectedFeb 25, 2026
High RiskFDA
Olympus Corporation Of The Americas
Brand Name: Olympus Everest Bipolar Cutting Forceps, 5 mm 33 cm Product Name: Everest Bipolar Cutting Forceps Model/Catalog Number: 300...
Surgical Devices106 affectedFeb 25, 2026
High RiskFDA
Olympus Corporation Of The Americas
Olympus Endoscope Suction Valve - MAJ-1443. Model Number: MAJ-1443.
Medical Devices47,383 affectedFeb 12, 2026
High RiskFDA
Olympus Corporation Of The Americas
Olympus Endoscope Reprocessor OER-Pro. Model Number: N3058140.
Medical Devices3,354 affectedFeb 12, 2026
High RiskFDA
Olympus Corporation Of The Americas
Olympus Endoscope Reprocessor OER-Elite. Model Number: N5789340.
Medical Devices2,929 affectedFeb 12, 2026
High RiskFDA
Olympus Corporation Of The Americas
Olympus Endoscope Air/Water Valve - MAJ-1444. Model Number: MAJ-1444.
Medical Devices89,579 affectedFeb 12, 2026
High RiskFDA
Olympus Corporation Of The Americas
Olympus Single use Biopsy Valve. Model/Catalog Number: MAJ-210. 20 units per box. The MAJ-210 has been designed to be attached to the ...
Medical Devices95,882 affectedJan 29, 2026
High RiskFDA
Olympus Corporation Of The Americas
Olympus Single Use Biopsy Valve. Model/Catalog Number: MAJ-1218. 20 units per box. The MAJ-1218 has been designed to be attached to th...
Medical Devices1,276 affectedJan 29, 2026
CriticalFDA
Olympus Corporation Of The Americas
Olympus High Flow Insufflation Unit. Model Number: UHI-3. Used for insufflation of the abdominal cavity, and automatic suction and sm...
Medical Devices485 affectedJan 16, 2026
CriticalFDA
Olympus Corporation Of The Americas
Olympus High Flow Insufflation Unit. Model/ Number: UHI-2. Used for insufflation of the abdominal cavity, and automatic suction and s...
Medical Devices744 affectedJan 16, 2026
High RiskFDA
Olympus Corporation Of The Americas
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-1520 Product Description: These instruments have been ...
Medical Devices3,954 affectedJan 7, 2026
High RiskFDA
Olympus Corporation Of The Americas
Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0330 Product Description: These instruments have bee...
Medical Devices886 affectedJan 7, 2026
High RiskFDA
Olympus Corporation Of The Americas
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-0330; Software Version: N/A Product Description: The...
Medical Devices33,433 affectedJan 7, 2026
High RiskFDA
Olympus Corporation Of The Americas
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-0725; Software Version: N/A Product Description: The...
Medical Devices136,037 affectedJan 7, 2026
High RiskFDA
Olympus Corporation Of The Americas
Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0730 Product Description: These instruments have bee...
Medical Devices1,490 affectedJan 7, 2026
High RiskFDA
Olympus Corporation Of The Americas
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-3025 Product Description: These instruments have been ...
Medical Devices1,025 affectedJan 7, 2026
High RiskFDA
Olympus Corporation Of The Americas
Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-431Q-0720 Product Description: These instruments have bee...
Medical Devices7,689 affectedJan 7, 2026
High RiskFDA
Olympus Corporation Of The Americas
Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0720 Product Description: These instruments have bee...
Medical Devices1,072 affectedJan 7, 2026
High RiskFDA
Olympus Corporation Of The Americas
Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC411Q-0725; Software Version: N/A Pro...
Medical Devices1,474 affectedJan 7, 2026
High RiskFDA
Olympus Corporation Of The Americas
Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-411Q-0730 Product Description: These instruments have bee...
Medical Devices887 affectedJan 7, 2026
High RiskFDA
Olympus Corporation Of The Americas
Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC411Q-0720; Software Version: N/A Pro...
Medical Devices10,008 affectedJan 7, 2026
High RiskFDA
Olympus Corporation Of The Americas
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V431M-0720; Software Version: N/A Product Description: The...
Medical Devices30,489 affectedJan 7, 2026
High RiskFDA
Olympus Corporation Of The Americas
Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC431Q-0730; Software Version: N/A Pr...
Medical Devices4,183 affectedJan 7, 2026
High RiskFDA
Olympus Corporation Of The Americas
Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-411Q-0720 Product Description: These instruments have bee...
Medical Devices125 affectedJan 7, 2026
High RiskFDA
Olympus Corporation Of The Americas
Brand Name: CleverCut Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-0320; Software Version: N/A Pr...
Medical Devices72,023 affectedJan 7, 2026
High RiskFDA
Olympus Corporation Of The Americas
Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number:KD-VC433Q-0730; Software Version: N/A Prod...
Medical Devices93 affectedJan 7, 2026
High RiskFDA
Olympus Corporation Of The Americas
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-0730; Software Version: N/A Product Description: The...
Medical Devices86,303 affectedJan 7, 2026
High RiskFDA
Olympus Corporation Of The Americas
Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC411Q-0320; Software Version: N/A Pro...
Medical Devices5,946 affectedJan 7, 2026
High RiskFDA
Olympus Corporation Of The Americas
Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC411Q-0730; Software Version: N/A Pro...
Medical Devices10,257 affectedJan 7, 2026
High RiskFDA
Olympus Corporation Of The Americas
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-3030 Product Description: These instruments have been ...
Medical Devices2,344 affectedJan 7, 2026
High RiskFDA
Olympus Corporation Of The Americas
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-3020 Product Description: These instruments have been ...
Medical Devices650 affectedJan 7, 2026
High RiskFDA
Olympus Corporation Of The Americas
Brand Name: ShockPulse-SE Lithotripsy System Product Name: ShockPulse-SE Lithotripsy System - Generator Model/Catalog Number: SPL-G Pr...
Medical Devices1,684 affectedNov 14, 2025
High RiskFDA
Olympus Corporation Of The Americas
Olympus Sheath, 10 Fr. Model No. A37004A. for endoscopic diagnosis and treatment in urological applications.
Medical Devices94 affectedNov 11, 2025
High RiskFDA
Olympus Corporation Of The Americas
Olympus Resection Sheath, 24 Fr., with Deflecting Obturator; Model No. A22041T. Resection sheath for urologic applications.
Medical Devices2,626 affectedNov 11, 2025
High RiskFDA
Olympus Corporation Of The Americas
Olympus Inner Sheath, Long; Model No. WA22017A. Inner sheath for urological and gynecological applications.
Medical Devices437 affectedNov 11, 2025