CLASS II ONGOING Device recall · Reported 5 Oct 2022 · FDA Enforcement Report
Olympus Powerseal, Curved Jaw Sealer & Divider, Double-action recalled
Olympus Corporation of the Americas is recalling Olympus Powerseal, Curved Jaw Sealer & Divider, Double-action, distributed nationwide in the US. The recall was initiated on 12 Aug 2022 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-1813-2022
- FDA event ID
- 90788
- Recalling firm
- Olympus Corporation of the Americas, Center Valley, PA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 12 Aug 2022
- FDA classified
- 26 Sep 2022
- Reported
- 5 Oct 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Device type
- Surgical Instruments
Timeline
| 12 Aug 2022 | Recall initiated by company | |
| 26 Sep 2022 | Classified by FDA | +45 days |
| 5 Oct 2022 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
An out of specification component preventing the blue retention ring from keeping the rotation knob in place. This may result in a loose rotation collar and retention ring and cause delay of treatment
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
Olympus POWERSEAL 5MM, 23CM, CURVED JAW SEALER & DIVIDER, DOUBLE-ACTION Model Number: PS-0523CJDA. An electrosurgical device use in laparoscopic/minimally invasive or open surgical procedures.
Where it was distributed
Nationwide OUS: AUSTRALIA, CANADA , HONG KONG, CHINA, KOREA
Questions about this recall
Is Olympus Powerseal, Curved Jaw Sealer & Divider, Double-action recalled?
Yes. Olympus Corporation of the Americas recalled Olympus Powerseal, Curved Jaw Sealer & Divider, Double-action on 12 Aug 2022. The recall is Class II and its status is Ongoing. Recall number Z-1813-2022.
Why was it recalled?
An out of specification component preventing the blue retention ring from keeping the rotation knob in place. This may result in a loose rotation collar and retention ring and cause delay of treatment
Which lots are affected?
UDI-DI: 00821925044531 Lot Numbers: CA191167 CA191168 CA191169 CA191170
Where was it sold?
Nationwide OUS: AUSTRALIA, CANADA , HONG KONG, CHINA, KOREA
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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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 |
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