CLASS II ONGOING Device recall · Reported 8 May 2024 · FDA Enforcement Report
Powerseal, Curved Jaw Sealer and Divider recalled
Olympus Corporation of the Americas is recalling Powerseal, Curved Jaw Sealer and Divider, Double Action is indicated for use in general, distributed nationwide in the US. The recall was initiated on 7 Mar 2024 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1700-2024
- FDA event ID
- 94375
- Recalling firm
- Olympus Corporation of the Americas, Center Valley, PA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 7 Mar 2024
- FDA classified
- 30 Apr 2024
- Reported
- 8 May 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Packaging Defects
- Device type
- Heart & Vascular Devices
Timeline
| 7 Mar 2024 | Recall initiated by company | |
| 30 Apr 2024 | Classified by FDA | +54 days |
| 8 May 2024 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
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
Where it was distributed
Worldwide distribution - US Nationwide and the countries of AU, CA, HK, KR.
Questions about this recall
Why was it 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.
Which lots are affected?
UDI-DI: 00821925044555 Lot numbers: CA182543, CA182544, CA182546, CA182548, CA191230
Where was it sold?
Worldwide distribution - US Nationwide and the countries of AU, CA, HK, KR.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
2 other products · FDA event 94375This product is part of a recall event; the main page for the event is Powerseal, Curved Jaw Sealer and Divider recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Powerseal, Curved Jaw Sealer and Divider recalled | Olympus Corporation of the Americas | Packaging Defects | Nationwide | |
| CLASS II | Powerseal, Curved Jaw Sealer and Divider recalled | Olympus Corporation of the Americas | Packaging Defects | Nationwide |
More recalls from Olympus Corporation of the Americas
All 415| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Powerseal (in diameter) (long), Curved Jaw Sealer & Divider recalled | Olympus Corporation of the Americas | Labeling Errors | Nationwide |
| Device | CLASS II | Olympus 4K UHD LCD Monitor recalled by Olympus Corporation of the | Olympus Corporation of the Americas | Other | Nationwide |
| Device | CLASS II | Olympus High Flow Insufflation Unit - UHI recalled | Olympus Corporation of the Americas | Other | Nationwide |
| Device | CLASS II | Olympus Toomey Evacuator 50cc with Adaptor recalled | Olympus Corporation of the Americas | Sterility | Nationwide |
| Device | CLASS II | Olympus Glass Body for 194 Ellik Evacuator recalled | Olympus Corporation of the Americas | Sterility | Nationwide |
Other Heart & Vascular Devices recalls
All 6,199| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Getinge PVC Thoracic Catheter, Soft PVC Right Angle recalled | Atrium Medical | Potency & Assay | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes: *Bardex¿ I.C recalled | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes recalled by C.R. Bard | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes recalled by C.R. Bard | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Getinge PVC Thoracic Catheter, Firm PVC Straight recalled | Atrium Medical | Potency & Assay | Nationwide |