Lower risk Medical device recall · FDA · Published March 7, 2024

Olympus POWERSEAL 5mm 44cm Sealer: Incomplete Seal Cycle Causes Surgery Delays

Olympus recalls POWERSEAL 5mm 44cm curved jaw sealers due to incomplete seal cycles causing surgery delays. Affected units have model PS-0544CJDA and lot code CA179370.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-1701-2024Medical device Olympus ›

Lower-risk 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.

Take action

Contact the company

Recalling firmOlympus Corporation of the Americas3500 Corporate Pkwy · Center Valley, PA 18034-8229

✎ GovInfoNow plain-language explainer

Olympus is recalling POWERSEAL surgical sealers that may not seal properly during surgery, causing delays. This could impact surgical timing and patient care. Read more at govinfonow.com/recall/55953-olympus-powerseal-5mm-44cm-sealer-incomplete-seal-cycle-causes-surgery.

Source Summary by GovInfoNow · govinfonow.com/recall/55953-olympus-powerseal-5mm-44cm-sealer-incomplete-seal-cycle-causes-surgery · Updated August 17, 2026 · FDA enforcement record: FDA #Z-1701-2024

Cite this page

“Olympus POWERSEAL 5mm 44cm Sealer: Incomplete Seal Cycle Causes Surgery Delays.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/55953-olympus-powerseal-5mm-44cm-sealer-incomplete-seal-cycle-causes-surgery. Based on FDA recall #Z-1701-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1701-2024%22&limit=1).

The FDA announced on March 7, 2024, that Olympus Corporation of the Americas is recalling its POWERSEAL 5 mm, 44 cm, Curved Jaw Sealer and Divider. The device may fail to deliver energy upon activation, causing a delay in surgery.

How to tell if you have it

Brand: Olympus
Product: POWERSEAL 5 mm, 44 cm, Curved Jaw Sealer and Divider
Model/Catalog Number: PS-0544CJDA
UDI-DI: 00821925044579
Lot Code: CA179370

The hazard

Upon initial activation of the seal function, the device may produce an Incomplete Seal Cycle tone and display a message on the generator screen without delivering energy. This non-conformance results in a delay in surgery.

Context

GovInfoNow's records show Olympus Corporation of the Americas has issued 133 other recalls since August 18, 2017. Recent brand recalls include the Olympus Tripp-Lite P580-025 DisplayPort Cable (August 27, 2026) and the Olympus M3 Gold Autoclavable Foroblique Telescope 30 (August 24, 2026). Other recent recalls of similar products include Medline convenience kits with Olympus biopsy valves (February 16, 2026) and the Olympus OER-Pro (October 31, 2025).

How to tell if you have this one

Check for model number PS-0544CJDA and lot code CA179370 on the device. These units were sold with the UDI-DI 00821925044579.

Brand
Olympus
Category
Medical device

FDA recall event · 3 products

All 3 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

Classification
Class II
Status
Ongoing
Distribution
Worldwide distribution - US Nationwide and the countries of AU, CA, HK, KR.

Recall number	Product, codes & lots	Quantity
Z-1699-2024	POWERSEAL 5 mm, 23 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-0523CJDA; UDI-DI: 00821925044531 Lot number: CA182554	160 units: (20 units US); (140 units OUS)
Z-1700-2024	POWERSEAL 5 mm, 37 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-0537CJDA; UDI-DI: 00821925044555 Lot numbers: CA182543, CA182544, CA182546, CA182548, CA191230	850 units: (400 units US);(450 units OUS)
Z-1701-2024	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; UDI-DI:00821925044579 Lot Code: CA179370	150 units: (20 units US); (130 units OUS)

Based on the official FDA remedy

What to do — step by step

Check Device Status
Verify if the device emits an incomplete seal cycle tone and shows no energy delivery during activation.

Where it went and when

Where it was distributed

Distributed nationwide, and outside the U.S.

FDA distribution: “Worldwide distribution - US Nationwide and the countries of AU, CA, HK, KR.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide, and outside the U.S.

Recall timeline

FDA published this recall 2 months after the firm started it.

Mar 7, 2024Firm started the recall
Apr 30, 2024FDA classified it Class II
May 8, 2024Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Keep exploring

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Link to this recall

<a href="https://govinfonow.com/recall/55953-olympus-powerseal-5mm-44cm-sealer-incomplete-seal-cycle-causes-surgery">Olympus POWERSEAL 5mm 44cm Sealer: Incomplete Seal Cycle Causes Surgery Delays (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-1701-2024 (March 7, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1701-2024 to see it in context.
Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.