CLASS II ONGOING Device recall · Reported 1 Apr 2026 · FDA Enforcement Report

HALO PKS Cutting Forceps recalled by Olympus Corporation of the

Olympus Corporation of the Americas is recalling HALO PKS Cutting Forceps, distributed nationwide in the US. The recall was initiated on 25 Feb 2026 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesModel: HACF0533; UDI: 00821925036390; Lot Numbers: All unexpired;

Quantity recalled2648 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1641-2026
FDA event ID: 98454
Recalling firm: Olympus Corporation of the Americas, Center Valley, PA
Classification: Class II
Status: Ongoing
Recall initiated: 25 Feb 2026
FDA classified: 25 Mar 2026
Reported: 1 Apr 2026
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Heart & Vascular Devices

Timeline

25 Feb 2026	Recall initiated by company
25 Mar 2026	Classified by FDA	+28 days
1 Apr 2026	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

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 electrosurgical energy under laparoscopic visualization. The device is intended to be used with the Gyrus ACMI G400 Workstation only.

Where it was distributed

Worldwide - US Nationwide and the countries of Canada, Mexico, EU, Australia, China, Singapore, Korea, Japan.

Nationwide

Questions about this recall

Why was it recalled?

Which lots are affected?

Model: HACF0533; UDI: 00821925036390; Lot Numbers: All unexpired;

Where was it sold?

Worldwide - US Nationwide and the countries of Canada, Mexico, EU, Australia, China, Singapore, Korea, Japan.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

6 other products · FDA event 98454

This product is part of a recall event; the main page for the event is Olympus PKS Cutting Forceps PKS Cutting Forceps recalled.

Reported	Class	Recall	Company	Reason	Where
1 Apr 2026	CLASS II	Olympus PKS Cutting Forceps PKS Cutting Forceps recalled	Olympus Corporation of the Americas	Device Malfunction	Nationwide
1 Apr 2026	CLASS II	PKS Cutting Forceps recalled by Olympus Corporation of the	Olympus Corporation of the Americas	Device Malfunction	Nationwide
1 Apr 2026	CLASS II	Olympus PK Cutting Forceps PK Cutting Forceps recalled	Olympus Corporation of the Americas	Device Malfunction	Nationwide
1 Apr 2026	CLASS II	Everest Bipolar Cutting Forceps recalled by Olympus Corporation of the	Olympus Corporation of the Americas	Device Malfunction	Nationwide
1 Apr 2026	CLASS II	Everest Bipolar Cutting Forceps recalled by Olympus Corporation of the	Olympus Corporation of the Americas	Device Malfunction	Nationwide
1 Apr 2026	CLASS II	Olympus PKS Cutting Forceps PKS Cutting Forceps recalled	Olympus Corporation of the Americas	Device Malfunction	Nationwide

More recalls from Olympus Corporation of the Americas

All 415

Reported	Class	Recall	Company	Reason	Where
2 Sep 2026Device	CLASS II	Powerseal (in diameter) (long), Curved Jaw Sealer & Divider recalled	Olympus Corporation of the Americas	Labeling Errors	Nationwide
29 Jul 2026Device	CLASS II	Olympus 4K UHD LCD Monitor recalled by Olympus Corporation of the	Olympus Corporation of the Americas	Other	Nationwide
29 Jul 2026Device	CLASS II	Olympus High Flow Insufflation Unit - UHI recalled	Olympus Corporation of the Americas	Other	Nationwide
22 Jul 2026Device	CLASS II	Olympus Toomey Evacuator 50cc with Adaptor recalled	Olympus Corporation of the Americas	Sterility	Nationwide
22 Jul 2026Device	CLASS II	Olympus Glass Body for 194 Ellik Evacuator recalled	Olympus Corporation of the Americas	Sterility	Nationwide

Other Heart & Vascular Devices recalls

All 6,199

Reported	Class	Recall	Company	Reason	Where
16 Sep 2026Device	CLASS II	Getinge PVC Thoracic Catheter, Soft PVC Right Angle recalled	Atrium Medical	Potency & Assay	Nationwide
16 Sep 2026Device	CLASS II	Products that contain the Pericare Wipes: *Bardex¿ I.C recalled	C.R. Bard	Other	Nationwide
16 Sep 2026Device	CLASS II	Products that contain the Pericare Wipes recalled by C.R. Bard	C.R. Bard	Other	Nationwide
16 Sep 2026Device	CLASS II	Products that contain the Pericare Wipes recalled by C.R. Bard	C.R. Bard	Other	Nationwide
16 Sep 2026Device	CLASS II	Getinge PVC Thoracic Catheter, Firm PVC Straight recalled	Atrium Medical	Potency & Assay	Nationwide