Z-1701-2024Class II

POWERSEAL 5 mm, 44 cm, Curved Jaw Sealer and Divider, Double Action is indicated for use in general surgery...

Name: Z-1701-2024 POWERSEAL 5 mm, 44 cm, Curved Jaw Sealer and Divider, Double Action is indicated for use in general surgery...
Creator: Olympus Corporation of the Americas
Published: 2024-03-07
License: https://open.fda.gov/license/

OLYMPUS Corporation of the Americas / initiated 2024-03-07 / Open, Classified / root cause: manufacturing process

FDA source

Olympus Corporation of the Americas began a recall of POWERSEAL 5 mm, 44 cm, Curved Jaw Sealer and Divider, Double Action is indicated for use in general surgery and such surgical specialties as urologic... on 2024-03-07. FDA classified it as Class II and gives the reason as "Upon initial activation of the seal function, the POWERSEAL non-conformance results in an immediate Incomplete Seal Cycle tone with the accompanying message on the generator screen, and no energy would be delivered to...". 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-1701-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-03-07
Posted: 2024-04-30
Recalling firm: OLYMPUS Corporation of the Americas
Product: POWERSEAL 5 mm, 44 cm, Curved Jaw Sealer and Divider, Double Action is indicated for use in general surgery and such surgical specialties as urologic, colorectal, bariatric, vascular, thoracic, and gynecologic. Model/Catalog Number: PS-0544CJDA
Product code: GEI Electrosurgical, Cutting & Coagulation & Accessories
Reason for recall: Upon initial activation of the seal function, the POWERSEAL non-conformance results in an immediate Incomplete Seal Cycle tone with the accompanying message on the generator screen, and no energy would be delivered to the device resulting in delay in surgery.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Olympus issued Urgent Medical Device Removal Letter on April 2, 2024 via email/visit. Letter states reason for recall, health risk and action to take: 1. Inspect your inventory and identify any POWERSEAL products having the lot number identified above. 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. 2. Please contact Customer Service at 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. 3. Access the Olympus recall portal to indicate that you have received this notification. a. Go to https://olympusamerica.com/recall b. Enter the recall number "0444 . c. Complete the form as instructed and include your account ID number. 4. If you have distributed these devices outside your facility, please provide a copy of this letter to those facilities immediately. If you require additional information, please do not hesitate to contact me directly by phone at (647) 999-3203 or by e-mail at [email protected]
Quantity in commerce: 150 units: (20 units US); (130 units OUS)
Distribution: Worldwide distribution - US Nationwide and the countries of AU, CA, HK, KR.
Product codes and lots: UDI-DI:00821925044579 Lot Code: CA179370

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1701-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1699-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-05-08	2024-04-30
Z-1700-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-05-08	2024-04-30
Z-1701-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-05-08	2024-04-30

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