Z-1167-2024Class II

Esg Pk Cutting Forceps, 5Mm, 33Cm

Name: Z-1167-2024 Esg Pk Cutting Forceps, 5Mm, 33Cm
Creator: Olympus Corporation of the Americas
Published: 2023-12-15
License: https://open.fda.gov/license/

OLYMPUS Corporation of the Americas / initiated 2023-12-15 / Open, Classified / root cause: labeling and UDI

FDA source

Olympus Corporation of the Americas began a recall of ESG PK CUTTING FORCEPS, 5MM, 33CM on 2023-12-15. FDA classified it as Class II and gives the reason as "The jaw may fracture prior to the procedure during the inspection instructed per the IFU, or during the procedure". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1167-2024
Classification: Class II
Status: Open, Classified
Initiated: 2023-12-15
Posted: 2024-02-20
Recalling firm: OLYMPUS Corporation of the Americas
Product: Esg Pk Cutting Forceps, 5Mm, 33Cm
Product code: GEI Electrosurgical, Cutting & Coagulation & Accessories
Reason for recall: The jaw may fracture prior to the procedure during the inspection instructed per the IFU, or during the procedure.
Root cause tag: labeling and UDI
FDA root cause: Under Investigation by firm
Action: On January 15, 2024, the firm notified customers of the issue via URGENT MEDICAL DEVICE REMOVAL letters. Customers were instructed to inspect your inventory and identify any products of the model and lots subject to this action. Please check all areas of the hospital to determine if any of these devices remain in inventory. Quarantine and cease use of the affected model/lots. Customers were given detailed instructions on how to identify affected product. Please contact your Olympus customer service representative at 1-800-848-9024, option 2 with the quantity, model and lot number of the affected device(s). Olympus will issue a Return Material Authorization to return any affected product at no charge. Olympus will issue a credit to your facility upon return of the affected product. Customers who have further distributed product should notify downstream accounts at once. If you require assistance with identifying affected product, please contact the Olympus Technical Assistance Center at 1- 800-848-9024, option 1, and the FDA. Adverse events experienced with the use of this product may also be reported to the FDA s MedWatch Adverse Event Reporting program either online, by regular mail, or by fax. If you have questions about this recall, please contact the recalling firm at (647) 999-3203 or by e-mail at [email protected].
Quantity in commerce: 11,123 units
Distribution: Worldwide distribution - US Nationwide and the countries of Australia, Canada, Germany, Mexico, P.R. China, Singapore, South Korea.
Product codes and lots: Model: PK-CF0533; UDI DI: 00821925035867; Lot Numbers: FR258486, FR261738, FR259544, FR263183, FR276278, FR279757, FR279625, FR279658, FR286369, FR287112, FR374622, FR207935, FR212413, FR212735, FR215061, FR216817, FR220525, FR222456, FR227254, FR227774, FR227781, FR232882, FR234845, FR247614, FR240430, FR246627, FR247039, FR248008, FR255679, FR248312, FR263636, FR263244, FR269280, FR269267, FR269269, FR287114, FR303799, FR297022, FR301062, PWO-308561, PWO-308562, PWO-308563, PWO-308560, PWO-308567, PWO-308566, PWO-308565, FR303864, FR313639, FR316869, FR319703, FR316872, FR327890, PWO-308972, FR335984, FR335990, FR337947, FR373912, FR401646, FR379790, FR347006;

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1167-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1167-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-02-28	2024-02-20

Product code GEI

K203277Class IIElectrosurgical Generator ESG-410, Foot Switches, PK Cutting ForcepsOlympus Winter & Ibe GmbH / cleared 2021-04-28

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)