FDA•MODERATE
Olympus PowerSeal 5 mm Curved Jaw Sealer & Divider
Olympus recalls PowerSeal 5 mm Curved Jaw Sealer & Divider over labeling error.
Olympus Corporation of the Americas
Olympus Corporation of the Americas: 14 recalls listed since February 2026 across FDA; 1 rated CRITICAL.
By year
- 202614
By agency
- FDA14
By category
- Medical Device14
All recalls (14)
FDA•MODERATEOlympus High Flow Insufflation Unit UHI-4Olympus recalls UHI-4 insufflation unit over unexpected display shutdown and air delivery loss.
FDA•MODERATEOlympus 4K UHD LCD MonitorOlympus is recalling the 4K UHD LCD Monitor (model OEV321UH) due to a potential connector fault that may cause image loss or abnormalities.
FDA•MODERATEOlympus Toomey Evacuator 30ccOlympus recalls Toomey Evacuator 30cc (Model 188) over sterilization failure risk.
4 products
FDA•MODERATEOlympus Single Use Distal CoverOlympus is replacing the previous design of the MAJ-2315 Single Use Distal Cover used with the EVIS EXERA III Duodenovideoscope.
FDA•MODERATEOlympus OER-ELITE Connecting TubesOlympus recalls OER-ELITE connecting tubes (MAJ-2110) due to premature lock lever failure.
12 products
FDA•MODERATEOlympus Thunderbeat II ShearsOlympus recalls Thunderbeat II Shears (model TB2-0520FC) over distal tip detachment risk.
4 products
FDA•MODERATEOlympus SOLTIVE Laser SystemOlympus recalls SOLTIVE laser systems (TFL-SLS, TFL-PLS) due to power supply defect that may cause inoperability and smoke.
2 products
FDA•MODERATEOlympus PKS Cutting ForcepsOlympus recalls PKS Cutting Forceps over jaw breakage risk from defective welds.
7 products
FDA•MODERATEOlympus Endoscope Air/Water and Suction ValvesOlympus recalls endoscope valves MAJ-1444 and MAJ-1443 over reprocessor incompatibility.
4 products
FDA•MODERATEOlympus ShockPulse-SE Lithotripsy System GeneratorOlympus is recalling the ShockPulse-SE Lithotripsy System generator due to a wiring issue that may cause treatment delays.
2 products
FDA•MODERATEOlympus Single Use Biopsy ValveOlympus is recalling the MAJ-210 single use biopsy valve due to the potential for rubber fragments to detach during use.
2 products- FDA•CRITICALOlympus High Flow Insufflation Unit
Olympus is recalling the UHI-3 High Flow Insufflation Unit due to a software issue that may cause dangerous overpressure events.
3 products 
FDA•MODERATEOlympus Single Use 3-Lumen Sphincterotome VOlympus is recalling the Single Use 3-Lumen Sphincterotome V (Model KD-V411M-1520) due to a risk of deformation and performance loss.
30 products