Olympus POWERSEAL Device Recall Due to Labeling Deficiency
Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.
Olympus Corporation of the Americas is recalling 335 units of POWERSEAL 5 MM 23 CM Curved Jaw Sealer & Divider due to incorrect labeling on outer shelf boxes.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on September 8, 2026 and geographically references United States. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, Devices.
What Happened
Olympus Corporation of the Americas initiated a voluntary recall due to a potential labeling deficiency in which an outer shelf box is incorrectly labeled as a 37-cm device.
Which Products Are Affected
POWERSEAL 5 MM (in diameter) 23 CM (long), Curved Jaw Sealer & Divider, Double Action (GEI / Electrosurgical, cutting & coagulation & accessories). Model Number: PS-0523CJDA. UDI-DI: 00821925044531. Lot Number: FR490902. A total of 335 units are affected. Distribution includes US states of Kansas and Florida, as well as Australia, European Union, and Japan.
What You Should Do
The recall is voluntary and firm initiated via letter. Consumers should refer to the FDA recall notice for additional guidance.
Why This Matters
This Class II recall addresses a labeling issue affecting electrosurgical devices distributed in multiple countries.
Source
FDA recall number Z-3035-2026. https://www.fda.gov
Original source: FDA Official Notice ↗
Related FDA Recalls
All FDA Recalls →Nationwide notices with similar length or severity timing 8
Two Areazine-derived peer sets for this FDA recall: nearest notices by body length and by same severity near the same agency date. Peers come from other categories so they are not the same-feed Related list above.
Similar body length
Nearest notices by article body length (933 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to September 8, 2026.
Frequently Asked Questions
Common questions about this FDA recall.