Olympus POWERSEAL Surgical Sealer Recalled for Non-Functional Seal Activation
Olympus POWERSEAL curved jaw sealers may fail to deliver energy during initial activation, causing incomplete seal cycles and surgical delays. Affected units should be removed from service immediately.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall of a surgical device with a non-functional seal mechanism that prevents proper device operation and causes surgical delays. No injuries or hospitalizations have been reported, placing this at the upper threshold for recalls with theoretical risk of harm but no documented patient injury.
Plain-English summary
Olympus Corporation of the Americas is recalling POWERSEAL 5 mm, 44 cm Curved Jaw Sealer and Divider, Double Action surgical instruments (Model PS-0544CJDA, Lot Code CA179370). These devices are used in general surgery and specialized procedures including urologic, colorectal, bariatric, vascular, thoracic, and gynecologic surgery.
The recalled devices exhibit a non-conformance that prevents energy delivery to the seal mechanism upon initial activation. When activated, an incomplete seal cycle tone sounds and a message appears on the generator screen, but no energy is delivered to the device. This failure prevents the device from functioning as intended and results in surgical delays.
The recall affects 150 units distributed worldwide: 20 units in the United States and 130 units distributed internationally to Australia, Canada, Hong Kong, and South Korea. Healthcare facilities and surgical providers should immediately identify and remove any devices matching this lot code from service and contact Olympus Corporation of the Americas for replacement or further instructions.
The recalled product
- 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
- Manufacturer
- Olympus Corporation of the Americas
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- UDI-DI:00821925044579 Lot Code: CA179370
Distribution
Part of a larger recall action
This product is one of 3 recalled by Olympus Corporation of the Americas under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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