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Brand Name: Olympus HALO PKS Cutting Forceps, 5mm 33cm recallZ-1641-2026 · Olympus Corporation of the Americas · initiated Feb 25, 2026

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Olympus Corporation of the Americas or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was 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.

FDA root cause category: Nonconforming Material/Component

What the company is doing

On February 25, 2026 URGENT: MEDICAL DEVICE REMOVAL letters were sent to customers. Actions to be taken: 1. Examine inventory and quarantine any affected devices 2. Cease usage of the product with immediate effect 3. Please contact Customer Service at 1-800-848-9024, option 2, to obtain a Return Material Authorization 4. Even if you no longer have the device, Olympus requests that you acknowledge receipt of this letter through the Olymps portal 5. Please forward this notice to other users who may have the affected products if you have further distributed it.

Recall details

Recall number
Z-1641-2026
Status
Open, Classified
Initiated by the company
Feb 25, 2026
Posted by the FDA
Mar 25, 2026
Recalling firm
Olympus Corporation of the Americas
Quantity
2648 units
Product code
GEI
FDA submissions
K100896
Distribution
Worldwide - US Nationwide and the countries of Canada, Mexico, EU, Australia, China, Singapore, Korea, Japan.

Product description

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.

Code information (models, lots, serial numbers)

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

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Other products in the same recall event

The FDA groups related products into one recall event (event 98454).

Sources and updates

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