Recall of Olympus Everest Bipolar Cutting Forceps Model 3005
Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.
Olympus is recalling 106 units of the Everest Bipolar Cutting Forceps due to potential jaw breakage from defective welds in the components.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on April 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, cpsc, Devices.
Recall Article
What Happened
Olympus identified that the Cutting Forceps contain components for which the supplier did not adequately validate the welding process, potentially resulting in the jaw breaking during clinical use.
Which Products Are Affected
The affected product is the Olympus Everest Bipolar Cutting Forceps, Model 3005. It includes 106 units with UDI: 00821925035881 and all unexpired lot numbers. The product is distributed nationwide in the US and to countries including Canada, Mexico, EU, Australia, China, Singapore, Korea, and Japan.
What You Should Do
Consumers should contact the recalling firm, Olympus Corporation of the Americas, as the recall was initiated via letter for further instructions on the affected devices.
Why This Matters
This recall affects 106 medical devices that could malfunction during procedures, potentially impacting patient safety in clinical settings.
Source
FDA Recall Number: Z-1638-2026
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 (963 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to April 8, 2026.
Frequently Asked Questions
Common questions about this FDA recall.