Olympus Cutting Forceps Recalled for Jaw Breaking Risk

Agency Publication Date: March 25, 2026

Summary

Olympus has recalled approximately 3,788 units of various Bipolar and PKS Cutting Forceps because the supplier did not properly validate the welding process for certain components. This manufacturing defect can cause the device's jaw to break off during surgery. The recall affects several models including Everest, PK, and HALO PKS variants distributed worldwide between February and March 2026.

Risk

A defective weld may cause the cutting forceps' jaw to break during clinical use, which could lead to surgical delays, tissue injury, or the unintended leaving of a metal fragment inside a patient's body.

What You Should Do

Identify if you have the affected devices by checking the model and UDI numbers on the product labeling or packaging. Affected models include 3005, 3006, PK-CF0533, HACF0533, 3005PK, 920000PK, and 920005PK with 'All unexpired' lot numbers.
See the Affected Products section below for the full list of affected codes.
Stop using the recalled device immediately to prevent patient injury.
Contact Olympus Corporation of the Americas or your local distributor to arrange for the return, replacement, or correction of the defective forceps.
Call the FDA at 1-888-463-6332 (1-888-INFO-FDA) for additional questions or to report an incident.

Your Remedy Options

Other Action

How to: Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: Olympus Everest Bipolar Cutting Forceps, 5 mm 33 cm

Variants: 5 mm, 33 cm

Model / REF:

3005

Lot Numbers:

All unexpired

UDI:

00821925035881

Recall #: Z-1638-2026; Intended for use with bipolar outputs of compatible generators.

Product: Olympus Everest Bipolar Cutting Forceps w/Cord, 5mm 33 cm

Variants: 5 mm, 33 cm, with Cord

Model / REF:

3006

Lot Numbers:

All unexpired

UDI:

00821925035898

Recall #: Z-1639-2026; Intended for use with bipolar outputs of compatible generators.

Product: Olympus PK Cutting Forceps, 5mm 33cm

Variants: 5 mm, 33 cm

Model / REF:

PK-CF0533

Lot Numbers:

All unexpired

UDI:

00821925035867

Recall #: Z-1640-2026; Used for cutting and coagulation during endoscopic or open surgical procedures.

Product: Olympus HALO PKS Cutting Forceps, 5mm 33cm

Variants: 5 mm, 33 cm

Model / REF:

HACF0533

Lot Numbers:

All unexpired

UDI:

00821925036390

Recall #: Z-1641-2026; Intended for use with the Gyrus ACMI G400 Workstation only.

Product: Olympus PKS Cutting Forceps, 5mm 33cm

Variants: 5 mm, 33 cm

Model / REF:

3005PK

Lot Numbers:

All unexpired

UDI:

00821925036000

Recall #: Z-1642-2026; Intended for use with the PKS electrical generator.

Product: Olympus PKS Cutting Forceps w/Cord, 5mm 24cm

Variants: 5 mm, 24 cm, with Cord

Model / REF:

920000PK

Lot Numbers:

All unexpired

UDI:

00821925038080

Recall #: Z-1643-2026; Intended for use with the PKS electrical generator.

Product: Olympus PKS Cutting Forceps, 5mm 33cm

Variants: 5 mm, 33 cm

Model / REF:

920005PK

Lot Numbers:

All unexpired

UDI:

00821925036178

Recall #: Z-1644-2026; Intended for use with the PKS electrical generator.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 98454

Status: Active

Manufacturer: Olympus Corporation of the Americas

Sold By: Olympus Corporation of the Americas; Surgical equipment distributors

Manufactured In: United States

Units Affected: 7 products (106 units; 164 units; 444 units; 2648 units; 93 units; 7 units; 326 units)

Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

Identify if you have the affected devices by checking the model and UDI numbers on the product labeling or packaging. Affected models include 3005, 3006, PK-CF0533, HACF0533, 3005PK, 920000PK, and 920005PK with 'All unexpired' lot numbers.

See the Affected Products section below for the full list of affected codes.

Stop using the recalled device immediately to prevent patient injury.

Contact Olympus Corporation of the Americas or your local distributor to arrange for the return, replacement, or correction of the defective forceps.

Call the FDA at 1-888-463-6332 (1-888-INFO-FDA) for additional questions or to report an incident.

Affected Products

Product: Olympus Everest Bipolar Cutting Forceps, 5 mm 33 cm

Variants: 5 mm, 33 cm

Model / REF:

3005

Lot Numbers:

All unexpired

UDI:

00821925035881

Recall #: Z-1638-2026; Intended for use with bipolar outputs of compatible generators.

Product: Olympus Everest Bipolar Cutting Forceps w/Cord, 5mm 33 cm

Variants: 5 mm, 33 cm, with Cord

Model / REF:

3006

Lot Numbers:

All unexpired

UDI:

00821925035898

Recall #: Z-1639-2026; Intended for use with bipolar outputs of compatible generators.

Product: Olympus PK Cutting Forceps, 5mm 33cm

Variants: 5 mm, 33 cm

Model / REF:

PK-CF0533

Lot Numbers:

All unexpired

UDI:

00821925035867

Recall #: Z-1640-2026; Used for cutting and coagulation during endoscopic or open surgical procedures.

Product: Olympus HALO PKS Cutting Forceps, 5mm 33cm

Variants: 5 mm, 33 cm

Model / REF:

HACF0533

Lot Numbers:

All unexpired

UDI:

00821925036390

Recall #: Z-1641-2026; Intended for use with the Gyrus ACMI G400 Workstation only.

Product: Olympus PKS Cutting Forceps, 5mm 33cm

Variants: 5 mm, 33 cm

Model / REF:

3005PK

Lot Numbers:

All unexpired

UDI:

00821925036000

Recall #: Z-1642-2026; Intended for use with the PKS electrical generator.

Product: Olympus PKS Cutting Forceps w/Cord, 5mm 24cm

Variants: 5 mm, 24 cm, with Cord

Model / REF:

920000PK

Lot Numbers:

All unexpired

UDI:

00821925038080

Recall #: Z-1643-2026; Intended for use with the PKS electrical generator.

Product: Olympus PKS Cutting Forceps, 5mm 33cm

Variants: 5 mm, 33 cm

Model / REF:

920005PK

Lot Numbers:

All unexpired

UDI:

00821925036178

Recall #: Z-1644-2026; Intended for use with the PKS electrical generator.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 98454

Status: Active

Manufacturer: Olympus Corporation of the Americas

Sold By: Olympus Corporation of the Americas; Surgical equipment distributors

Manufactured In: United States

Units Affected: 7 products (106 units; 164 units; 444 units; 2648 units; 93 units; 7 units; 326 units)

Distributed To: Nationwide