Z-1643-2026Class II

Brand Name: Olympus PKS Cutting Forceps w/Cord, 5mm 24cm Product Name: PKS Cutting Forceps Model/Catalog...

Name: Z-1643-2026 Brand Name: Olympus PKS Cutting Forceps w/Cord, 5mm 24cm Product Name: PKS Cutting Forceps Model/Catalog...
Creator: Olympus Corporation of the Americas
Published: 2026-02-25
License: https://open.fda.gov/license/

OLYMPUS Corporation of the Americas / initiated 2026-02-25 / Open, Classified / root cause: manufacturing process

FDA source

Olympus Corporation of the Americas began a recall of Brand Name: Olympus PKS Cutting Forceps w/Cord, 5mm 24cm Product Name: PKS Cutting Forceps Model/Catalog Number: 920000PK Product Description: The PKS Cutting... on 2026-02-25. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1643-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-02-25
Posted: 2026-03-25
Recalling firm: OLYMPUS Corporation of the Americas
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 visualization. The device is intended to be used with the PKS electrical generator.
Product code: GEI Electrosurgical, Cutting & Coagulation & Accessories
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.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: 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.
Quantity in commerce: 7 units
Distribution: Worldwide - US Nationwide and the countries of Canada, Mexico, EU, Australia, China, Singapore, Korea, Japan.
Product codes and lots: Model: 920000PK; UDI: 00821925038080; Lot Numbers: All unexpired;

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1643-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1638-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-04-01	2026-03-25
Z-1639-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-04-01	2026-03-25
Z-1640-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-04-01	2026-03-25
Z-1641-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-04-01	2026-03-25
Z-1642-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-04-01	2026-03-25
Z-1643-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-04-01	2026-03-25
Z-1644-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-04-01	2026-03-25

Product code GEI

K023492Class IIEverest Bipolar Cutting Forceps and Gyrus Bipolar Cutting ForcepsGyrus Medical, Inc. / cleared 2002-11-13

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)