Olympus HALO PKS Cutting Forceps recalled for defective welds causing jaw breakage
Stop using Olympus HALO PKS Cutting Forceps
Olympus discovered that some HALO PKS Cutting Forceps (model HACF0533) have defective welds in their components. During surgery, the forceps' jaw can break when the welds fail, potentially affecting the procedure. This affects medical facilities worldwide that use these surgical instruments with the Gyrus ACMI G400 Workstation.
- Stop using HALO PKS Cutting Forceps model HACF0533 immediately
- Contact your hospital or surgical facility's device coordinator if you have these forceps
- Do not use affected instruments until you receive guidance from Olympus or the FDA
Olympus identified that the Cutting Forceps contain components for which the supplier did not adequately validate the welding process. Defective welds can result in the Cutting Forceps' jaw breaking during clinical use.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1641-2026More Olympus Corporation of the Americas recalls
- FDA-Device2026-07-29Olympus High Flow Insufflation Unit UHI-4 recalled for unexpected display shutdown and air delivery loss
- FDA-Device2026-07-29Olympus OEV321UH 4K UHD LCD Monitor recalled for faulty HDMI and DisplayPort connectors
- FDA-Device2026-07-22Olympus Ellik Evacuator Model 194 recalled for inadequate sterilization parameters
- FDA-Device2026-07-22Olympus Toomey Evacuator 30cc with Adaptor recalled for inadequate sterilization
- FDA-Device2026-07-22Olympus Glass Body for 194 Ellik Evacuator recalled for inadequate sterilization
Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief