Powerseal 5 Mm recall
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…
Why was Powerseal 5 Mm recalled?
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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI-DI: 00821925044531 Lot number: CA182554
- Product
- 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…
- Recalling firm
- Olympus Corporation of the Americas
- Quantity
- 160 units: (20 units US); (140 units OUS)
- Distribution
- Worldwide distribution - US Nationwide and the countries of AU, CA, HK, KR.
- Recall date
- May 8, 2024
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)