Z-1815-2022Class II

Olympus POWERSEAL 5MM, 44CM, CURVED JAW SEALER & DIVIDER, DOUBLE-ACTION Model Number: PS-0544CJDA. An...

Name: Z-1815-2022 Olympus POWERSEAL 5MM, 44CM, CURVED JAW SEALER & DIVIDER, DOUBLE-ACTION Model Number: PS-0544CJDA. An...
Creator: Olympus Corporation of the Americas
Published: 2022-08-12
License: https://open.fda.gov/license/

OLYMPUS Corporation of the Americas / initiated 2022-08-12 / Open, Classified

FDA source

Olympus Corporation of the Americas began a recall of Olympus POWERSEAL 5MM, 44CM, CURVED JAW SEALER & DIVIDER, DOUBLE-ACTION Model Number: PS-0544CJDA. An electrosurgical device use in laparoscopic/minimally... on 2022-08-12. FDA classified it as Class II and gives the reason as "An out of specification component preventing the blue retention ring from keeping the rotation knob in place. This may result in a loose rotation collar and retention ring and cause delay of treatment". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1815-2022
Classification: Class II
Status: Open, Classified
Initiated: 2022-08-12
Posted: 2022-09-26
Recalling firm: OLYMPUS Corporation of the Americas
Product: Olympus POWERSEAL 5MM, 44CM, CURVED JAW SEALER & DIVIDER, DOUBLE-ACTION Model Number: PS-0544CJDA. An electrosurgical device use in laparoscopic/minimally invasive or open surgical procedures.
Product code: GEI Electrosurgical, Cutting & Coagulation & Accessories
Reason for recall: An out of specification component preventing the blue retention ring from keeping the rotation knob in place. This may result in a loose rotation collar and retention ring and cause delay of treatment
FDA root cause: Under Investigation by firm
Action: Olympus issued Urgent Medical Device Recall Letter on 8/12/22 to Surgical Department Risk Management. Letter states reason for recall, health risk and action to take: 1. Immediately locate any product with affected lot numbers listed in this communication. See Attachment 2 for pictures showing the location of lot numbers on the package. 2. Call your Olympus customer service representative at 1 800 848 9024, option 2. Olympus will issue a Return Material Authorization to return any affected product at no charge to you. Olympus will issue a credit to your facility upon return of 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 0412 and provide your contact information as indicated in the portal. 4. If you have distributed these devices outside your facility, please notify your customers of this removal action immediately. Your notification to your customers may be enhanced by including a copy of this recall notification letter. Contact directly at (647) 999-3203 or at [email protected] for any additional information or support concerning this matter.
Quantity in commerce: 44 units (5/box); 133 units (5/box) OUS
Distribution: Nationwide OUS: AUSTRALIA, CANADA , HONG KONG, CHINA, KOREA
Product codes and lots: UDI-DI: 00821925044579 Lot Numbers: CA191182 CA191183 CA191184 CA191185 CA191186 CA236235 CA236237 FR230559

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1815-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1813-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-10-05	2022-09-26
Z-1814-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-10-05	2022-09-26
Z-1815-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-10-05	2022-09-26

Product code GEI

K212643Class IIPOWERSEAL Curved Jaw Sealer and Divider, Double ActionOlympus Surgical Technologies America / cleared 2021-09-27

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)