Olympus Corporation of the Americas recalls

All Olympus Corporation of the Americas recalls we track from FDA, CPSC and NHTSA data. Categories: medical devices (189).

189 recalls published between October 23, 2024 and September 30, 2026. Most common issues: sterility (14), laceration (9), burn (8), software (3). 30 were FDA Class I, the most serious level.

• Olympus BiCOAG Hemostasis Probe 7Fr Fixed Pin Connector recall
  FDA September 30, 2026 · Olympus Corporation of the Americas · Class II
• Olympus BiCOAG Hemostasis Probe 7Fr Coaxial Connector recall
  FDA September 30, 2026 · Olympus Corporation of the Americas · Class II
• Olympus BiCOAG Hemostasis Probe 10Fr Fixed Pin Connector recall
  FDA September 30, 2026 · Olympus Corporation of the Americas · Class II
• Olympus BiCOAG Hemostasis Probe 10Fr Coaxial Connector recall
  FDA September 30, 2026 · Olympus Corporation of the Americas · Class II
• Olympus EZDilate Endoscopic Balloon Dilator Wired-guided 11, 12, 13mm recall
  FDA September 30, 2026 · Olympus Corporation of the Americas · Class II
• POWERSEAL 5 MM (in diameter) 23 CM (long), Curved Jaw Sealer & Divider… recall
  FDA September 2, 2026 · Olympus Corporation of the Americas · Class II
• Olympus High Flow Insufflation Unit - UHI-4. Model Number: UHI-4 recall
  FDA July 29, 2026 · Olympus Corporation of the Americas · Class II
• Olympus 4K UHD LCD Monitor recall
  FDA July 29, 2026 · Olympus Corporation of the Americas · Class II
• Olympus Glass Body for 194 Ellik Evacuator recall
  FDA July 22, 2026 · Olympus Corporation of the Americas · Class II
• Olympus Ellik Evacuator Includes Glass Body… recall
  FDA July 22, 2026 · Olympus Corporation of the Americas · Class II
• Olympus Toomey Evacuator 50cc with Adaptor recall
  FDA July 22, 2026 · Olympus Corporation of the Americas · Class II
• Olympus Toomey Evacuator 30cc with Adaptor recall
  FDA July 22, 2026 · Olympus Corporation of the Americas · Class II
• Olympus Single Use Distal Cover recall
  FDA July 15, 2026 · Olympus Corporation of the Americas · Class II
• OER-ELITE Endoscope Reprocessor Connecting Tubes recall
  FDA April 29, 2026 · Olympus Corporation of the Americas · Class II
• OER-ELITE Endoscope Reprocessor Connecting Tubes recall
  FDA April 29, 2026 · Olympus Corporation of the Americas · Class II
• OER-ELITE Endoscope Reprocessor Connecting Tubes recall
  FDA April 29, 2026 · Olympus Corporation of the Americas · Class II
• OER-ELITE Endoscope Reprocessor Connecting Tubes recall
  FDA April 29, 2026 · Olympus Corporation of the Americas · Class II
• OER-ELITE Endoscope Reprocessor Connecting Tubes recall
  FDA April 29, 2026 · Olympus Corporation of the Americas · Class II
• OER-ELITE Endoscope Reprocessor Connecting Tubes recall
  FDA April 29, 2026 · Olympus Corporation of the Americas · Class II
• OER-ELITE Endoscope Reprocessor Connecting Tubes recall
  FDA April 29, 2026 · Olympus Corporation of the Americas · Class II
• OER-ELITE Endoscope Reprocessor Connecting Tubes recall
  FDA April 29, 2026 · Olympus Corporation of the Americas · Class II
• OER-ELITE Endoscope Reprocessor Connecting Tubes recall
  FDA April 29, 2026 · Olympus Corporation of the Americas · Class II
• OER-ELITE Endoscope Reprocessor Connecting Tubes recall
  FDA April 29, 2026 · Olympus Corporation of the Americas · Class II
• OER-ELITE Endoscope Reprocessor Connecting Tubes recall
  FDA April 29, 2026 · Olympus Corporation of the Americas · Class II
• OER-ELITE Endoscope Reprocessor Connecting Tubes recall
  FDA April 29, 2026 · Olympus Corporation of the Americas · Class II
• Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 45cm recall
  FDA April 29, 2026 · Olympus Corporation of the Americas · Class II
• Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 35cm recall
  FDA April 29, 2026 · Olympus Corporation of the Americas · Class II
• Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 25cm recall
  FDA April 29, 2026 · Olympus Corporation of the Americas · Class II
• Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 20cm recall
  FDA April 29, 2026 · Olympus Corporation of the Americas · Class II
• Olympus SOLTIVE Pro SuperPulsed Laser System Product Name: SOLTIVE Pro… recall
  FDA April 8, 2026 · Olympus Corporation of the Americas · Class II
• Olympus SOLTIVE Premium SuperPulsed Laser System Product Name: SOLTIVE… recall
  FDA April 8, 2026 · Olympus Corporation of the Americas · Class II
• Olympus PKS Cutting Forceps, 5mm 33cm Product Name: PKS Cutting Forceps… recall
  FDA April 1, 2026 · Olympus Corporation of the Americas · Class II
• Olympus PKS Cutting Forceps w/Cord, 5mm 24cm Product Name: PKS Cutting… recall
  FDA April 1, 2026 · Olympus Corporation of the Americas · Class II
• Olympus PKS Cutting Forceps, 5mm 33cm Product Name: PKS Cutting Forceps… recall
  FDA April 1, 2026 · Olympus Corporation of the Americas · Class II
• Olympus HALO PKS Cutting Forceps, 5mm 33cm Product Name: HALO PKS Cutting… recall
  FDA April 1, 2026 · Olympus Corporation of the Americas · Class II
• Olympus PK Cutting Forceps, 5mm 33cm Product Name: PK Cutting Forceps Model recall
  FDA April 1, 2026 · Olympus Corporation of the Americas · Class II
• Olympus Everest Bipolar Cutting Forceps w/Cord… recall
  FDA April 1, 2026 · Olympus Corporation of the Americas · Class II
• Olympus Everest Bipolar Cutting Forceps, 5 mm 33 cm Product Name: Everest… recall
  FDA April 1, 2026 · Olympus Corporation of the Americas · Class II
• Olympus Endoscope Reprocessor OER-Pro recall
  FDA April 1, 2026 · Olympus Corporation of the Americas · Class II
• Olympus Endoscope Reprocessor OER-Elite recall
  FDA April 1, 2026 · Olympus Corporation of the Americas · Class II
• Olympus Endoscope Air/Water Valve - MAJ-1444. Model Number: MAJ-1444 recall
  FDA April 1, 2026 · Olympus Corporation of the Americas · Class II
• Olympus Endoscope Suction Valve - MAJ-1443. Model Number: MAJ-1443 recall
  FDA April 1, 2026 · Olympus Corporation of the Americas · Class II
• Olympus ShockPulse-SE Lithotripsy System with Generator Product Name:… recall
  FDA March 11, 2026 · Olympus Corporation of the Americas · Class II
• Olympus Single Use Biopsy Valve recall
  FDA March 11, 2026 · Olympus Corporation of the Americas · Class II
• Olympus Single use Biopsy Valve recall
  FDA March 11, 2026 · Olympus Corporation of the Americas · Class II
• ShockPulse-SE Lithotripsy System Product Name: ShockPulse-SE Lithotripsy… recall
  FDA March 11, 2026 · Olympus Corporation of the Americas · Class II
• ShockPulse-SE Lithotripsy System SPL-S Product Name: ShockPulse-SE… recall
  FDA March 11, 2026 · Olympus Corporation of the Americas · Class II
• ShockPulse-SE Lithotripsy System SPL-SR Product Name: ShockPulse-SE… recall
  FDA March 11, 2026 · Olympus Corporation of the Americas · Class II
• Olympus Resection Sheath recall
  FDA March 4, 2026 · Olympus Corporation of the Americas · Class II
• Olympus Inner Sheath recall
  FDA March 4, 2026 · Olympus Corporation of the Americas · Class II
• Olympus Inner Sheath recall
  FDA March 4, 2026 · Olympus Corporation of the Americas · Class II
• Olympus Sheath, 10 Fr recall
  FDA March 4, 2026 · Olympus Corporation of the Americas · Class II
• Olympus Inner Sheath 21 Fr recall
  FDA March 4, 2026 · Olympus Corporation of the Americas · Class II
• Olympus Resection Sheath recall
  FDA March 4, 2026 · Olympus Corporation of the Americas · Class II
• Olympus Inner Sheath, Long recall
  FDA March 4, 2026 · Olympus Corporation of the Americas · Class II
• Olympus Inner Sheath, Long recall
  FDA March 4, 2026 · Olympus Corporation of the Americas · Class II
• Olympus Inner Sheath recall
  FDA March 4, 2026 · Olympus Corporation of the Americas · Class II
• Olympus Resection Sheath, 8 mm recall
  FDA March 4, 2026 · Olympus Corporation of the Americas · Class II
• Olympus Inner Sheath recall
  FDA March 4, 2026 · Olympus Corporation of the Americas · Class II
• Olympus Resection Sheath, 28 Fr recall
  FDA March 4, 2026 · Olympus Corporation of the Americas · Class II