HIGH
FDA DEVICE
OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2116.
Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.
Olympus Corporation of the Americas
Potential for
Olympus Corporation of the Americas Recalls
115 recalls found for Olympus Corporation of the Americas. Check if any of your products are affected.
HIGH
FDA DEVICE
OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2119.
Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.
Olympus Corporation of the Americas
Potential for
HIGH
FDA DEVICE
OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2111
Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.
Olympus Corporation of the Americas
Potential for
HIGH
FDA DEVICE
OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2117.
Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.
Olympus Corporation of the Americas
Potential for
HIGH
FDA DEVICE
OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2113.
Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.
Olympus Corporation of the Americas
Potential for
HIGH
FDA DEVICE
OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2115.
XXX
Olympus Corporation of the Americas
XXX
HIGH
FDA DEVICE
OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2112
Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.
Olympus Corporation of the Americas
Potential for
HIGH
FDA DEVICE
OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2114.
Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.
Olympus Corporation of the Americas
Potential for
HIGH
FDA DEVICE
OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2118.
Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.
Olympus Corporation of the Americas
Potential for
HIGH
FDA DEVICE
OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2138.
Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.
Olympus Corporation of the Americas
Potential for
HIGH
FDA DEVICE
OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2110. May be included with the Olympus OER-ELITE.
Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.
Olympus Corporation of the Americas
Potential for
HIGH
FDA DEVICE
Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 45cm. Model Number: TB2-0545FC.
Potential for detachment of a distal tip component of the device during use.
Olympus Corporation of the Americas
Potential for
HIGH
FDA DEVICE
Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 35cm. Model Number: TB2-0535FC.
Potential for detachment of a distal tip component of the device during use.
Olympus Corporation of the Americas
Potential for
HIGH
FDA DEVICE
Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 25cm. Model Number: TB2-0525FC.
Potential for detachment of a distal tip component of the device during use.
Olympus Corporation of the Americas
Potential for
HIGH
FDA DEVICE
Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 20cm. Model Number: TB2-0520FC.
Potential for detachment of a distal tip component of the device during use.
Olympus Corporation of the Americas
Potential for
Health & Personal Care
HIGH
FDA DEVICE
Olympus SOLTIVE Premium Laser System Recall Affects 408 Units Worldwide (2026)
Olympus recalls 408 SOLTIVE Premium Laser System units worldwide after a defect in the 24V power supply may render the system inoperable and cause smoke or a burning smell. The issue is contained within the internal console and would self-extinguish. Hospitals should stop using the device immediately and follow recall instructions.
Olympus Corporation of the Americas
Following a
Health & Personal Care
HIGH
FDA DEVICE
Olympus HALO PKS Cutting Forceps HACF0533 Recalled for Jaw Breakage; 2,648 Units Worldwide (2026)
Olympus Corporation of the Americas is recalling 2,648 HALO PKS Cutting Forceps HACF0533 sold to hospitals and clinics worldwide. The jaw can break during surgical use due to a supplier welding-validation issue. Healthcare facilities should stop using the device immediately and follow Olympus recall instructions for disposition.
Olympus Corporation of the Americas
Olympus identified
Health & Personal Care
HIGH
FDA DEVICE
Olympus PK Cutting Forceps Recall 444 Units Worldwide Over Welding Defect (2026)
Olympus Corporation of the Americas is recalling 444 PK-CF0533 cutting forceps distributed worldwide. The devices may have welding defects that can cause the jaw to break during surgery. Stop using the device and follow recall instructions from Olympus or your healthcare provider.
Olympus Corporation of the Americas
Olympus identified
Health & Personal Care
HIGH
FDA DEVICE
Olympus Everest Bipolar Cutting Forceps Recalled Worldwide for Welding Defect (164 Units, 2026)
Olympus Corporation of the Americas recalled 164 Everest Bipolar Cutting Forceps worldwide on Feb. 25, 2026. A supplier welding process was not adequately validated, risking jaw breakage during surgical use. Clinicians should stop using the device and follow Olympus recall instructions.
Olympus Corporation of the Americas
Olympus identified
Health & Personal Care
HIGH
FDA DEVICE
Olympus PKS Cutting Forceps 920005PK Recalled for Jaw Break Risk (2026)
Olympus Corporation of the Americas recalled 326 PKS Cutting Forceps worldwide. The devices may have welding defects that cause the jaw to break during use. Stop using the device immediately and follow the recall instructions provided by Olympus.
Olympus Corporation of the Americas
Olympus identified
Brand Statistics
Total Recalls
115
Pages
6