Z-2380-2021Class II

Gyrus Acmi PKS Omni 5mm/33cm-intended for the electrosurgical coagulation, mechanical grasping, and...

Name: Z-2380-2021 Gyrus Acmi PKS Omni 5mm/33cm-intended for the electrosurgical coagulation, mechanical grasping, and...
Creator: Olympus Corporation of the Americas
Published: 2021-06-09
License: https://open.fda.gov/license/

OLYMPUS Corporation of the Americas / initiated 2021-06-09 / Terminated / root cause: manufacturing process

FDA source

Olympus Corporation of the Americas began a recall of Gyrus Acmi PKS Omni 5mm/33cm-intended for the electrosurgical coagulation, mechanical grasping, and dissection of tissue during the performance of laparoscopic... on 2021-06-09. FDA classified it as Class II and gives the reason as "Expired adhesive used as an electrical insulation barrier and as a secondary retention bond failed and could result in foreign body / biologic reaction within the patient and / or electrical continuity to patient...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2380-2021
Classification: Class II
Status: Terminated
Initiated: 2021-06-09
Posted: 2021-08-27
Terminated: 2023-02-17
Recalling firm: OLYMPUS Corporation of the Americas
Product: Gyrus Acmi PKS Omni 5mm/33cm-intended for the electrosurgical coagulation, mechanical grasping, and dissection of tissue during the performance of laparoscopic and general open surgical procedures when used in conjunction with the Gyrus ACMI G400 workstation Ref: 970010PC
Product code: GEI Electrosurgical, Cutting & Coagulation & Accessories
Reason for recall: Expired adhesive used as an electrical insulation barrier and as a secondary retention bond failed and could result in foreign body / biologic reaction within the patient and / or electrical continuity to patient causing tissue burn to critical structures.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Olympus issued Urgent Medical Device Recall Letter on June 9th 2021 via Federal Express two day mail. Letter states reason for recall, health risk and action to take: 1. Immediately cease any further use of any affected product you have, remove it from your inventory and quarantine it until it is shipped back to us. 2. Call your Olympus customer service representative at 1-888-524-7266 option 1. Olympus will issue a Return Material Authorization to return any affected product. at no charge to you. Olympus will issue a credit or replacement to your facility for your affected product. 3. Access the Olympus recall portal to indicate that you have received this notification. Go to https://olympusamerica.com/recall. Enter the recall number Recall-0395 and provide your contact information as indicated in the portal. In addition, if you have further distributed this product, please identify your customers, notify them at once of this product recall, and appropriately document your notification process. Your notification to your customers may be enhanced by including a copy of this recall notification letter. Contact me directly at 484-896-5688 or at [email protected] for any additional information concerning this matter.
Quantity in commerce: 6 boxes (5 per/box)=30 units
Distribution: US Nationwide distribution in the states of CA, GA, MN, TN.
Product codes and lots: Lot number KR121617

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2380-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2380-2021	Class II	Terminated	Voluntary: Firm initiated	2021-09-08	2021-08-27

Product code GEI

K081766Class IIPks Omni InstrumentGyrus-Acmi L.P. / cleared 2008-08-08

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)