The Recall Desk

FDA (Devices) recall action 98454

Olympus Corporation of the Americas recalled 7 products on 2026-04-01

The FDA (Devices) publishes a recall like this one as 7 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 7 pages.

Products
7
Announced
2026-04-01
Critical
0
Units
3,788

Why these products were recalled

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.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–7 of 7

  • HighFDA (Devices)··2026-04-01

    Olympus HALO PKS cutting forceps jaws may break from defective welds

    Olympus is recalling HALO PKS Cutting Forceps because a supplier did not adequately validate the welding process, and defective welds can cause the forceps jaw to break during clinical use.

    Product
    Brand Name: Olympus HALO PKS Cutting Forceps, 5mm 33cm Product Name: HALO PKS Cutting Forceps Model/Catalog Number: HACF0533 Product Description: The HALO PKS Cutting Forceps are intended to be passed through a 5 mm laparoscopic cannula. Coagulation is achieved using electro
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    0 states
  • HighFDA (Devices)··2026-04-01

    Olympus Everest bipolar forceps model 3005 jaws may break

    Olympus is recalling Everest Bipolar Cutting Forceps model 3005 because a supplier did not adequately validate the welding process, and defective welds can cause the jaw to break during clinical use.

    Product
    Brand Name: Olympus Everest Bipolar Cutting Forceps, 5 mm 33 cm Product Name: Everest Bipolar Cutting Forceps Model/Catalog Number: 3005 Product Description: The OLYMPUS Everest Bipolar Cutting Forceps are intended to be passed through a 5 mm cannula. Coagulation is achieved u
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    0 states
  • HighFDA (Devices)··2026-04-01

    Olympus Everest bipolar cutting forceps jaws may break from defective welds

    Olympus is recalling Everest Bipolar Cutting Forceps because a supplier did not adequately validate the welding process, and defective welds can cause the forceps jaw to break during clinical use.

    Product
    Brand Name: Olympus Everest Bipolar Cutting Forceps w/Cord, 5mm 33 cm Product Name: Everest Bipolar Cutting Forceps Model/Catalog Number: 3006 Product Description: The OLYMPUS Everest Bipolar Cutting Forceps are intended to be passed through a 5 mm cannula. Coagulation is achi
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    0 states
  • HighFDA (Devices)··2026-04-01

    Olympus PK cutting forceps jaws may break from defective welds

    Olympus is recalling PK Cutting Forceps because a supplier did not adequately validate the welding process, and defective welds can cause the forceps jaw to break during clinical use.

    Product
    Brand Name: Olympus PK Cutting Forceps, 5mm 33cm Product Name: PK Cutting Forceps Model/Catalog Number: PK-CF0533 Product Description: An assembly of devices intended to generate and apply radio-frequency (RF) alternating current to soft tissues for cutting and coagulation dur
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    0 states
  • HighFDA (Devices)··2026-04-01

    Olympus PKS cutting forceps jaws may break from defective welds

    Olympus is recalling PKS Cutting Forceps because a supplier did not adequately validate the welding process, and defective welds can cause the forceps jaw to break during clinical use.

    Product
    Brand Name: Olympus PKS Cutting Forceps, 5mm 33cm Product Name: PKS Cutting Forceps Model/Catalog Number: 920005PK Product Description: The PKS Cutting Forceps are intended to be passed through a 5mm cannula. Coagulation is achieved using electrosurgical energy under visuali
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    0 states
  • HighFDA (Devices)··2026-04-01

    Olympus PKS cutting forceps 920000PK jaws may break from welds

    Olympus is recalling PKS Cutting Forceps with cord, model 920000PK, because a supplier did not adequately validate the welding process and defective welds can cause the jaw to break.

    Product
    Brand Name: Olympus PKS Cutting Forceps w/Cord, 5mm 24cm Product Name: PKS Cutting Forceps Model/Catalog Number: 920000PK Product Description: The PKS Cutting Forceps are intended to be passed through a 5mm cannula. Coagulation is achieved using electrosurgical energy under
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    0 states
  • HighFDA (Devices)··2026-04-01

    Olympus PKS cutting forceps 3005PK jaws may break from defective welds

    Olympus is recalling PKS Cutting Forceps model 3005PK because a supplier did not adequately validate the welding process and defective welds can cause the jaw to break during clinical use.

    Product
    Brand Name: Olympus PKS Cutting Forceps, 5mm 33cm Product Name: PKS Cutting Forceps Model/Catalog Number: 3005PK Product Description: The PKS Cutting Forceps are intended to be passed through a 5mm cannula. Coagulation is achieved using electrosurgical energy under visualiza
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    0 states