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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 Devices·2,089 affected·Mar 25, 2026
High RiskFDA
Olympus Corporation Of The Americas
OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2113.
Medical Devices·8,936 affected·Mar 25, 2026
High RiskFDA
Olympus Corporation Of The Americas
OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2119.
Medical Devices·741 affected·Mar 25, 2026
High RiskFDA
Olympus Corporation Of The Americas
OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2114.
Medical Devices·2,143 affected·Mar 25, 2026
High RiskFDA
Olympus Corporation Of The Americas
OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2138.
Medical Devices·808 affected·Mar 25, 2026
High RiskFDA
Olympus Corporation Of The Americas
OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2118.
Medical Devices·1,259 affected·Mar 25, 2026
High RiskFDA
Olympus Corporation Of The Americas
OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2112
Medical Devices·8,994 affected·Mar 25, 2026
High RiskFDA
Olympus Corporation Of The Americas
Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 45cm. Model Number: TB2-0545FC.
Medical Devices·490 affected·Mar 23, 2026
High RiskFDA
Olympus Corporation Of The Americas
Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 20cm. Model Number: TB2-0520FC.
Medical Devices·830 affected·Mar 23, 2026
High RiskFDA
Olympus Corporation Of The Americas
Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 35cm. Model Number: TB2-0535FC.
Medical Devices·3,360 affected·Mar 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 Devices·408 affected·Feb 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 Devices·93 affected·Feb 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 Devices·7 affected·Feb 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 Devices·444 affected·Feb 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 Devices·106 affected·Feb 25, 2026
High RiskFDA
Olympus Corporation Of The Americas
Olympus Endoscope Suction Valve - MAJ-1443. Model Number: MAJ-1443.
Medical Devices·47,383 affected·Feb 12, 2026
High RiskFDA
Olympus Corporation Of The Americas
Olympus Endoscope Reprocessor OER-Pro. Model Number: N3058140.
Medical Devices·3,354 affected·Feb 12, 2026
High RiskFDA
Olympus Corporation Of The Americas
Olympus Endoscope Reprocessor OER-Elite. Model Number: N5789340.
Medical Devices·2,929 affected·Feb 12, 2026
High RiskFDA
Olympus Corporation Of The Americas
Olympus Endoscope Air/Water Valve - MAJ-1444. Model Number: MAJ-1444.
Medical Devices·89,579 affected·Feb 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 Devices·95,882 affected·Jan 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 Devices·1,276 affected·Jan 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 Devices·485 affected·Jan 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 Devices·744 affected·Jan 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 Devices·3,954 affected·Jan 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 Devices·886 affected·Jan 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 Devices·33,433 affected·Jan 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 Devices·136,037 affected·Jan 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 Devices·1,490 affected·Jan 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 Devices·1,025 affected·Jan 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 Devices·7,689 affected·Jan 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 Devices·1,072 affected·Jan 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 Devices·1,474 affected·Jan 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 Devices·887 affected·Jan 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 Devices·10,008 affected·Jan 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 Devices·30,489 affected·Jan 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 Devices·4,183 affected·Jan 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 Devices·125 affected·Jan 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 Devices·72,023 affected·Jan 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 Devices·93 affected·Jan 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 Devices·86,303 affected·Jan 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 Devices·5,946 affected·Jan 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 Devices·10,257 affected·Jan 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 Devices·2,344 affected·Jan 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 Devices·650 affected·Jan 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 Devices·1,684 affected·Nov 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 Devices·94 affected·Nov 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 Devices·2,626 affected·Nov 11, 2025
High RiskFDA
Olympus Corporation Of The Americas
Olympus Inner Sheath, Long; Model No. WA22017A. Inner sheath for urological and gynecological applications.
Medical Devices·437 affected·Nov 11, 2025